@Article{info:doi/10.2196/63854, author="Hess, W. Courtney and Rosenbloom, N. Brittany and Mesaroli, Giulia and Lopez, Cristal and Ngo, Nhat and Cohen, Estreya and Ouellette, Carley and Gold, I. Jeffrey and Logan, Deirdre and Simons, E. Laura and Stinson, N. Jennifer", title="Extended Reality (XR) in Pediatric Acute and Chronic Pain: Systematic Review and Evidence Gap Map", journal="JMIR Pediatr Parent", year="2025", month="Apr", day="7", volume="8", pages="e63854", keywords="virtual reality", keywords="augmented reality", keywords="extended reality", keywords="acute pain", keywords="chronic pain", keywords="pediatrics", keywords="adolescents", keywords="safety", keywords="feasibility", keywords="effectiveness", keywords="evidence gap map", keywords="child", keywords="children", keywords="VR", keywords="XR", keywords="biobehavioral", keywords="intervention", keywords="systematic review", abstract="Background: The use of extended reality (XR), including virtual reality (VR) and augmented reality (AR), for treating pain has accelerated in the last 10 years. XR is an attractive biobehavioral intervention that may support management of pain or pain-related disability. Reviews of the literature pertaining to adults report promising results, particularly for acute procedural pain. Objective: This study aimed to (1) summarize the available evidence with respect to feasibility, safety, and effectiveness (pain intensity) of XR for pediatric acute and chronic pain; (2) summarize assessment tools used to measure study outcomes; and (3) identify gaps in evidence to guide future research efforts. Methods: This study is a systematic review of the literature. Multiple databases (CINAHL, Cochrane Central, Embase, MEDLINE, PsycINFO) were searched from inception until March 2023. Titles, abstracts, and full-text articles were reviewed by 2 team members to determine eligibility. Articles were included if the (1) participants were aged 0 to 18 years; (2) study intervention was VR or AR; (3) study outcomes included safety, feasibility, acceptability, or effectiveness on the outcome of pain; and (4) study design was observational or interventional. Data were collected on bibliographic information; study characteristics; XR characteristics; outcome domains; outcome measures; and study findings pertaining to safety, feasibility, and effectiveness. Results: We included 90 articles in the review. All included studies used VR, and 93\% (84/90) studied VR in the context of acute pain. Of the 90 studies, 74 studies were randomized trials, and 15 studies were observational. Safety was assessed in 23 studies of acute pain, with 13 studies reporting no adverse events and 10 studies reporting events of low concern. Feasibility was assessed in 27 studies. Of the 84 studies of acute pain, 62\% (52/84) reported a positive effect on pain intensity, 21\% (18/84) reported no effect, and 13\% (11/84) reported mixed effects. All 6 studies of chronic pain reported a positive effect on pain intensity. An evidence gap map was used to illuminate gaps in specific research areas stratified by subtypes of pain. Risk of bias assessment revealed 67 studies had a moderate risk of bias, 17 studies had a high risk, and 5 studies were deemed to be low risk. Conclusions: The current body of literature around XR for pediatric pain is focused on acute pain with promising results of safety and effectiveness on pain intensity. The literature pertaining to chronic pain lags behind, limiting our ability to draw conclusions. The risk of bias in studies is problematic in this field, with the inherent challenge of blinding participants and researchers to the intervention. Future research should aim to measure effectiveness beyond pain intensity with a consistent approach to measuring key outcome domains and measures. Current efforts are underway to establish expert consensus on best research practices in this field. Trial Registration: Prospero CRD42022307153; https://www.crd.york.ac.uk/PROSPERO/view/CRD42022307153 ", doi="10.2196/63854", url="https://pediatrics.jmir.org/2025/1/e63854" } @Article{info:doi/10.2196/63098, author="Liszio, Stefan and B{\"a}uerlein, Franziska and Hildebrand, Jens and van Nahl, Carolin and Masuch, Maic and Basu, Oliver", title="Cooperative Virtual Reality Gaming for Anxiety and Pain Reduction in Pediatric Patients and Their Caregivers During Painful Medical Procedures: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2025", month="Mar", day="31", volume="14", pages="e63098", keywords="virtual reality", keywords="extended reality", keywords="mixed reality", keywords="serious game", keywords="video game", keywords="pain", keywords="anxiety", keywords="stress", keywords="child", keywords="caregiver", keywords="patient experience", keywords="well-being", keywords="medical procedures", keywords="punctures", keywords="distraction", keywords="intervention", abstract="Background: The hospital experience is often marked by fear and pain, particularly for children undergoing medical procedures. Sedation is commonly used to alleviate patient anxiety, but it poses additional health risks. Caregivers, usually the parents, also experience emotional distress during the child's hospital stay, which can further exacerbate the child's anxiety and pain. While various interventions exist to ease patient distress, few consider the emotional well-being of caregivers. Objective: This study aims to explore the effectiveness of a cooperative virtual reality (VR) game as a novel nonpharmacological solution to reduce anxiety and pain for both pediatric patients and their caregivers during medical procedures. Specifically, we aim to investigate whether the VR game ``Sweet Dive VR'' (SDVR), designed for children aged between 6 and 12 years to play with 1 caregiver, can alleviate anxiety and pain during different types of needle punctures and Kirschner-wire removal. Methods: A prospective multicenter randomized clinical trial will be conducted. Eligible participants will be identified by scanning the hospital information system, and group allocation will follow stratified randomization. During the medical procedure, patients in the VR condition will play SDVR with a caregiver present, while patients in the control group will listen to a recording of gently crashing waves. Data collection will be carried out through self-reports of patients and caregivers using visual analog scales and questionnaires at 2 measurement time points: before and after the intervention. In addition, observation by the interviewers will occur during the intervention to capture emotional and pain reactions as well as interaction quality between patients and caregivers and smoothness of the procedure flow using a structured observation protocol. The measured variables will encompass patient affect and pain, caregiver affect, player experience, patient experience, and the flow of the procedure. Results: As of November 2024, we enrolled 39 patients and caregivers, 28 of whom completed the study. Data collection is still ongoing. Conclusions: Cooperative VR gaming, as exemplified by SDVR, emerges as a promising intervention to address anxiety and pain in pediatric patients while involving caregivers to support the emotional well-being of both parties. Our approach strives to foster positive shared experiences and to maintain trust between children and caregivers during emotionally challenging medical situations. Trial Registration: German Clinical Trial Register (DRKS) DRKS00033544; https://drks.de/search/en/trial/DRKS00033544 International Registered Report Identifier (IRRID): DERR1-10.2196/63098 ", doi="10.2196/63098", url="https://www.researchprotocols.org/2025/1/e63098" } @Article{info:doi/10.2196/58784, author="Slatman, Syl and Heesink, Lieke and Achterkamp, Reinoud and Broeks, Jos{\'e} and Monteiro de Oliveira, Nelson and ter Riet, Remko and Stegeman, Marjolein and Tabak, Monique", title="At-Home Virtual Reality Intervention for Patients With Chronic Musculoskeletal Pain: Single-Case Experimental Design Study", journal="JMIR XR Spatial Comput", year="2025", month="Mar", day="4", volume="2", pages="e58784", keywords="virtual reality", keywords="VR", keywords="chronic musculoskeletal pain", keywords="CMP", keywords="single-case experimental design", keywords="SCED", keywords="user experience", keywords="self-management", keywords="musculoskeletal pain", abstract="Background: Virtual reality (VR) could possibly alleviate complaints related to chronic musculoskeletal pain (CMP); however, little is known about how it affects pain-related variables on an individual level and how patients experience this intervention. Objective: This study aimed to gain detailed insight into the influence of an at-home VR intervention for pain education and management on pain-related variables, and to explore its feasibility and general experience. Methods: The study applied a single-case experimental design in which an at-home VR intervention was used for 4 weeks by patients with CMP who were on a waiting list for regular pain treatment. Outcome measures included pain-related variables, functioning, and objectively measured outcomes (ie, stress, sleep, and steps). Outcomes were analyzed using data visualization (based on line plots) and statistical methods (ie, Tau-U and reliable change index) on an individual and group level. In addition, a focus group was conducted to assess feasibility and general experience to substantiate findings from the single-case experimental design study. This focus group was analyzed using inductive thematic analysis. Results: A total of 7 participants (female: n=6, 86\%) with a median age of 45 (range 31?61) years participated in this study. A dataset with 42 measurement moments was collected with a median of 280 (range 241?315) data points per participant. No statistically significant or clinically relevant differences between the intervention and no-intervention phases were found. Results of the visual analysis of the diary data showed that patients responded differently to the intervention. Results of the focus group with 3 participants showed that the VR intervention was perceived as a feasible and valued additional intervention. Conclusions: Although patients expressed a positive perspective on this VR intervention, it did not seem to influence pain-related outcomes. Individual patients responded differently to the intervention, which implies that this intervention might not be suitable for all patients. Future studies should examine which CMP patients VR is effective for and explore its working mechanisms. In addition, future larger trials should be conducted to complement this study's findings on the effectiveness of this intervention for patients with CMP and whether VR prevents deterioration on the waiting list compared with a control group. ", doi="10.2196/58784", url="https://xr.jmir.org/2025/1/e58784" } @Article{info:doi/10.2196/59922, author="Ding, E. Michael and Traiba, Hajar and Perez, R. Hector", title="Virtual Reality Interventions and Chronic Pain: Scoping Review", journal="J Med Internet Res", year="2025", month="Feb", day="18", volume="27", pages="e59922", keywords="virtual reality", keywords="chronic pain", keywords="scoping review", keywords="pain management", keywords="efficacy", keywords="anxiety disorders", keywords="mood", keywords="health condition", keywords="health intervention", keywords="adults", keywords="aging", keywords="therapeutic", keywords="descriptive--analytical method", keywords="monitoring", keywords="US", keywords="PRISMA", abstract="Background: Virtual reality (VR) interventions have demonstrated efficacy for more than a decade for mood and anxiety disorders and emerging evidence suggests they can reduce pain symptoms in both acute and chronic pain. More recently, these interventions have abounded within the commercial and academic sectors, immersing participants within a virtual environment to confer health benefits to users. VR immersion can facilitate the delivery of health interventions by isolating participants from distractors and stressors in a therapeutic environment. While recent studies of VR interventions have exploded, they are not uniform in approach or device type, limiting generalizability. Recent scoping reviews on VR and chronic pain have focused on specific diseases or limited inquiries to specific interventions or study types. Objective: We conducted a scoping review to generate new knowledge about the sum total of VR studies on chronic pain with specific emphasis on the methods and results of each study, including (1) the type of interventions, (2) outcomes chosen, (3) samples studied, and (4) data generated. Methods: A scoping review was performed on the literature on VR and chronic pain to describe themes associated with the literature to date and identify important gaps and unanswered questions to guide future research. CINAHL [EBSCO] (Cumulative Index to Nursing and Allied Health Literature) and PubMed were queried for the terms ``virtual reality'' and ``pain,'' providing studies of chronic pain adult participants using VR delivered through headset displays. We included English-language manuscripts that had at least one VR intervention arm with adults with chronic pain. For this analysis, we only included VR interventions that were immersive (ie, using headsets). Non--study reports, studies with no specific chronic pain component, those not involving adults, and those using VR as part of a comprehensive rehabilitation program were excluded. A descriptive analytical method was used to extract data, compare studies, and contextualize the presented outcomes. Articles were categorized into several themes including the type of intervention, outcomes chosen, participant characteristics, degree to which immersion was achieved, and adverse effect monitoring and reporting. Results: A total of 36 articles were included in our analysis. We summarize the literature using 5 themes: (1) heterogeneity of chronic pain types, (2) highly variable intervention types, (3) highly variable secondary and exploratory outcomes, (4) immersion was highly variable between studies and not systemically explored in many articles, and (5) side effect monitoring was limited. Conclusions: The literature on VR in chronic pain is highly variable and lacks theoretical rigor. While there is emerging evidence that supports VR use in a wide variety of health conditions including chronic pain, future research should focus on producing theoretically rigorous work that focuses on mechanisms and that systematically assesses side effects to generate robust generalizable knowledge. ", doi="10.2196/59922", url="https://www.jmir.org/2025/1/e59922" } @Article{info:doi/10.2196/57826, author="Griefahn, Annika and Avermann, Florian and Zalpour, Christoff and Marshall, Percy Robert and Cordon Morillas, In{\'e}s and Luedtke, Kerstin", title="Exploring the Effect of an 8-Week AI-Composed Exercise Program on Pain Intensity and Well-Being in Patients With Spinal Pain: Retrospective Cohort Analysis", journal="JMIR Form Res", year="2025", month="Feb", day="18", volume="9", pages="e57826", keywords="exercise", keywords="mHealth", keywords="app engagement", keywords="spinal pain", keywords="artificial intelligence", keywords="AI", keywords="intensity", keywords="well-being", keywords="mobile health", keywords="apps", keywords="applications", keywords="retrospective analysis", keywords="physical activity", keywords="adults", keywords="questionnaire", abstract="Background: Spinal pain, one of the most common musculoskeletal disorders (MSDs), significantly impacts the quality of life due to chronic pain and disability. Physical activity has shown promise in managing spinal pain, although optimizing adherence to exercise remains a challenge. The digital development of artificial intelligence (AI)-driven applications offers a possibility for guiding and supporting patients with MSDs in their daily lives. Objective: The trial aimed to investigate the effect of an 8-week AI-composed exercise program on pain intensity and well-being in patients with spinal pain. It also examined the relationship between exercise frequency, pain intensity, and well-being. In addition, app usage frequency was examined as a proxy for app engagement. Methods: Data from users who met the inclusion criteria were collected retrospectively from the medicalmotion app between January 1, 2020, and June 30, 2023. The intervention involved the use of the medicalmotion app, which provides 3?5 personalized exercises for each session based on individual user data. The primary outcomes assessed pain intensity and well-being using the numeric rating scale (NRS) and the Likert scale. Data were collected at baseline (t0), 4 weeks (t1), and 8 weeks (t2). The correlation between exercise frequency, pain intensity, and well-being was analyzed as a secondary outcome. In addition, average session length and frequency were measured to determine app engagement. Statistical analysis included ANOVA and Spearman correlation analysis. Results: The study included 379 participants with a mean age of 50.96 (SD 12.22) years. At t2, there was a significant reduction of 1.78 points on the NRS (P<.001). The score on the Likert scale for well-being improved by 3.11 points after 8 weeks. Pain intensity showed a negative correlation with the number of daily exercises performed at t1 and t2. Well-being had a small negative correlation with the average number of exercises performed per day. The average number of exercises performed per day was 3.58. The average session length was approximately 10 minutes, and the average interaction with the app was 49.2\% (n=27.6 days) of the 56 available days. Conclusions: Overall, the study demonstrates that an app-based intervention program can substantially reduce pain intensity and increase well-being in patients with spinal pain. This retrospective study showed that an app that digitizes multidisciplinary rehabilitation for the self-management of spinal pain significantly reduced user-reported pain intensity in a preselected population of app users. Trial Registration: OSF Registries osf.io/kjhef; https://osf.io/kjhef ", doi="10.2196/57826", url="https://formative.jmir.org/2025/1/e57826" } @Article{info:doi/10.2196/50635, author="Vermeir, F. Julie and White, J. Melanie and Johnson, Daniel and Crombez, Geert and Van Ryckeghem, L. Dimitri M.", title="Gamified Web-Delivered Attentional Bias Modification Training for Adults With Chronic Pain: Randomized, Double-Blind, Placebo-Controlled Trial", journal="JMIR Serious Games", year="2025", month="Jan", day="16", volume="13", pages="e50635", keywords="chronic pain", keywords="cognition", keywords="attentional bias", keywords="gamification", keywords="motivation", keywords="randomized controlled trial", keywords="web-based intervention", keywords="pain management", keywords="digital intervention", keywords="digital health", abstract="Background: Attentional bias to pain-related information has been implicated in pain chronicity. To date, research investigating attentional bias modification training (ABMT) procedures in people with chronic pain has found variable success, perhaps because training paradigms are typically repetitive and monotonous, which could negatively affect engagement and adherence. Increasing engagement through the gamification (ie, the use of game elements) of ABMT may provide the opportunity to overcome some of these barriers. However, ABMT studies applied to the chronic pain field have not yet incorporated gamification elements. Objective: This study aimed to investigate the effects of a gamified web-delivered ABMT intervention in a sample of adults with chronic pain via a randomized, double-blind, placebo-controlled trial. Methods: A final sample of 129 adults with chronic musculoskeletal pain, recruited from clinical (hospital outpatient waiting list) and nonclinical (wider community) settings, were included in this randomized, double-blind, placebo-controlled, 3-arm trial. Participants were randomly assigned to complete 6 web-based sessions of nongamified standard ABMT (n=43), gamified ABMT (n=41), or a control condition (nongamified sham ABMT; n=45) over a period of 3 weeks. Active ABMT conditions trained attention away from pain-related words. The gamified task included a combination of 5 game elements. Participant outcomes were assessed before training, during training, immediately after training, and at 1-month follow-up. Primary outcomes included self-reported and behavioral engagement, pain intensity, and pain interference. Secondary outcomes included anxiety, depression, cognitive biases, and perceived improvement. Results: Results of the linear mixed model analyses suggest that across all conditions, there was an overall small to medium decline in self-reported task-related engagement between sessions 1 and 2 (P<.001; Cohen d=0.257; 95\% CI 0.13-0.39), sessions 1 and 3 (P<.001; Cohen d=0.368; 95\% CI 0.23-0.50), sessions 1 and 4 (P<.001; Cohen d=0.473; 95\% CI 0.34-0.61), sessions 1 and 5 (P<.001; Cohen d=0.488; 95\% CI 0.35-0.63), and sessions 1 and 6 (P<.001; Cohen d=0.596; 95\% CI 0.46-0.73). There was also an overall small decrease in depressive symptoms from baseline to posttraining assessment (P=.007; Cohen d=0.180; 95\% CI 0.05-0.31) and in pain intensity (P=.008; Cohen d=0.180; 95\% CI 0.05-0.31) and pain interference (P<.001; Cohen d=0.237; 95\% CI 0.10-0.37) from baseline to follow-up assessment. However, no differential effects were observed over time between the 3 conditions on measures of engagement, pain intensity, pain interference, attentional bias, anxiety, depression, interpretation bias, or perceived improvement (all P values>.05). Conclusions: These findings suggest that gamification, in this context, was not effective at enhancing engagement, and they do not support the widespread clinical use of web-delivered ABMT in treating individuals with chronic musculoskeletal pain. The implications of these findings are discussed, and future directions for research are suggested. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000803998; https://anzctr.org.au/ACTRN12620000803998.aspx International Registered Report Identifier (IRRID): RR2-10.2196/32359 ", doi="10.2196/50635", url="https://games.jmir.org/2025/1/e50635" } @Article{info:doi/10.2196/58734, author="Funao, Hiroki and Momosaki, Ryo and Tsujikawa, Mayumi and Kawamoto, Eiji and Esumi, Ryo and Shimaoka, Motomu", title="Virtual Reality--Applied Home-Visit Rehabilitation for Patients With Chronic Pain: Protocol for Single-Arm Pre-Post Comparison Study", journal="JMIR Res Protoc", year="2024", month="Dec", day="30", volume="13", pages="e58734", keywords="chronic pain", keywords="homebound patient", keywords="home-visit rehabilitation", keywords="virtual reality", keywords="protocol", keywords="feasibility study", keywords="VR", keywords="pain", keywords="recurrent pain", keywords="home visit", keywords="rehabilitation", keywords="home rehabilitation", keywords="in-home", keywords="effective", keywords="screening", keywords="VR intervention", keywords="feasibility", keywords="alleviate pain", abstract="Background: Pain inhibits rehabilitation. In rehabilitation at medical institutions, the usefulness of virtual reality (VR) has been reported in many cases to alleviate pain. In recent years, the demand for home rehabilitation has increased. Unlike in medical situations, the patients targeted for in-home rehabilitation often have chronic pain due to physical and psychosocial factors, and the environment is not specialized for rehabilitation. However, VR might be effective for in-home rehabilitation settings. Objective: This study aims to evaluate the feasibility of applying VR to home-visit rehabilitation for homebound patients with chronic pain. Methods: This study will test the feasibility of VR applied to home-visit rehabilitation for patients with chronic pain. A single-arm pre-post comparison will be conducted to evaluate its feasibility. Screening will be conducted on patients who have given consent to participate in the study, and those who have pain that persists or recurs for more than 3 months and receive home-visit rehabilitation will be enrolled in the study. Baseline measurements will be conducted on study participants before the start of the VR intervention. VR-applied home-visit rehabilitation will be conducted once a week for a total of 10 VR interventions. The primary endpoint is the change in pain from the baseline to the tenth intervention. Pain is a subjective symptom of the study participants and will be subjectively assessed by the Numerical Rating Scale of 11 levels from 0 to 10. Pain as the primary endpoint will be measured at 3-time points per rehabilitation session: before, during, and after the rehabilitation so that changes between time points can be evaluated. Secondary endpoints are heart rate variability, range of motion of the area in the musculoskeletal system where the pain occurs, motivation for rehabilitation, catastrophic thoughts of pain, mood state, quality of life, and interviews. Assessments will be conducted at the baseline, first, fifth, and tenth interventions. After completing the clinical study (10 VR interventions), patients will continue their regular home-visit rehabilitation as usual. Results: Recruitment of participants began on February 22, 2022, and data collection is ongoing as of November 2024. The research results will be published in international peer-reviewed journals and through presentations at national and international conferences. Conclusions: This study will contribute to the development of novel rehabilitation-based solutions for homebound patients who have had difficulty obtaining adequate relief from chronic pain. Future studies will consider conducting randomized controlled trials as clinical trials to validate the efficacy of VR during home-visit rehabilitation for patients with chronic pain. International Registered Report Identifier (IRRID): DERR1-10.2196/58734 ", doi="10.2196/58734", url="https://www.researchprotocols.org/2024/1/e58734" } @Article{info:doi/10.2196/52340, author="Knobel, J. Samuel E. and Oberson, Raphael and R{\"a}ber, Jonas and Sch{\"u}tz, Narayan and Egloff, Niklaus and Botros, Angela and Gerber, M. Stephan and Nef, Tobias and Heydrich, Lukas", title="Evaluation of a New Mobile Virtual Reality Setup to Alter Pain Perception: Pilot Development and Usability Study in Healthy Participants", journal="JMIR Serious Games", year="2024", month="Dec", day="11", volume="12", pages="e52340", keywords="immersive virtual reality", keywords="embodiment", keywords="pain management", keywords="chronic pain", keywords="full-body illusion", keywords="cardiovisual illusion", keywords="pain", keywords="virtual reality", keywords="pilot study", keywords="development", keywords="mobile virtual reality", keywords="mobile", keywords="virtual environment", keywords="usability", keywords="heart rate", keywords="mobile phone", abstract="Background: Chronic pain presents a significant treatment challenge, often leading to frustration for both patients and therapists due to the limitations of traditional methods. Research has shown that synchronous visuo-tactile stimulation, as used in the rubber hand experiment, can induce a sense of ownership over a fake body part and reduces pain perception when ownership of the fake body part is reported. The effect of the rubber hand experiment can be extended to the full body, for example, during the full-body illusion, using both visuo-tactile and cardiovisual signals. Objective: This study first aimed to evaluate the usability and accuracy of a novel, mobile virtual reality (VR) setup that displays participants' heartbeats as a flashing silhouette on a virtual avatar, a technique known as the cardiovisual full-body illusion. The second part of the study investigated the effects of synchronous cardiovisual stimulation on pain perception and ownership in 20 healthy participants as compared with asynchronous stimulation (control condition). Methods: The setup comprised a head-mounted display (HMD) and a heart rate measurement device. A smartphone-based HMD (Samsung Galaxy S8+) was selected for its mobility, and heart rates were measured using smartwatches with photoplethysmography (PPG). The accuracy of 2 smartwatch positions was compared with a 5-point electrocardiogram (ECG) standard in terms of their accuracy (number and percent of missed beats). Each participant underwent two 5-minute sessions of synchronous cardiovisual stimulation and two 5-minute sessions of asynchronous cardiovisual stimulation (total of 4 sessions), followed by pain assessments. Usability, symptoms of cybersickness, and ownership of the virtual body were measured using established questionnaires (System Usability Scale, Simulator Sickness Questionnaire, Ownership Questionnaire). Pain perception was assessed using advanced algometric methods (Algopeg and Somedic algometer). Results: Results demonstrated high usability scores (mean 4.42, SD 0.56; out of 5), indicating ease of use and acceptance, with minimal side effects (mean 1.18, SD 0.46; out of a possible 4 points on the Simulator Sickness Questionnaire). The PPG device showed high heart rate measurement precision, which improved with optimized filtering and peak detection algorithms. However, compared with previous work, no significant effects on body ownership and pain perception were observed between the synchronous and asynchronous conditions. These findings are discussed in the context of existing literature on VR interventions for chronic pain. Conclusions: In conclusion, while the new VR setup showed high usability and minimal side effects, it did not significantly affect ownership or pain perception. This highlights the need for further research to refine VR-based interventions for chronic pain management, considering factors like visual realism and perspective. ", doi="10.2196/52340", url="https://games.jmir.org/2024/1/e52340" } @Article{info:doi/10.2196/52294, author="Pe{\~n}a, Jorge and Koebner, Ian and Weisman, William", title="Using Digital Art and Attachment Priming in a Web-Based Serious Game to Reduce Pain and Social Disconnection in Individuals With Chronic Pain and Loneliness: Randomized Controlled Trial", journal="JMIR Serious Games", year="2024", month="Nov", day="27", volume="12", pages="e52294", keywords="pain", keywords="social disconnection", keywords="loneliness", keywords="randomized controlled trial", keywords="art", keywords="museums", keywords="virtual reality", keywords="serious games", keywords="virtual art", keywords="chronic pain and loneliness", keywords="attachment", keywords="priming", keywords="mediation", keywords="intervention", keywords="cyberpsychology", keywords="mental health", abstract="Background: Arts engagement using virtual reality and serious games represent promising nonpharmacological self-management treatment approaches to chronic pain. This study is the first randomized controlled trial to explore the impact of a web-based serious game that simulated a visit to an art museum on pain and social disconnection among individuals living with chronic pain and loneliness. Objective: This study aimed to test the joint and separate effects of exposure to digital art and attachment figure priming on pain and social disconnection among individuals living with chronic pain and loneliness. Methods: This randomized controlled trial used a 2 (digital artwork present and absent) {\texttimes} 2 (secure attachment and avoidant attachment prime) repeated measures factorial web-based experimental design with a hanging control condition. Mediation and moderation analyses examined how feelings about the social world triggered by the artwork and frequency of museum visits impacted the effects of the interventions on pain and social disconnection. Results: The results are based on 308 participants. Mean age of the participants was 42.78 (SD 13.11; range 18-76) years, and 60.2\% (n=186) were women. Posttest pain was lower than pretest pain for the artwork present (P=.001) and absent (P=.001) conditions. Similarly, posttest pain was lower than pretest pain for the secure (P=.001) and avoidant (P=.001) attachment priming conditions. Relative to the control group, artwork present (P=.001) and absent (P=.01) conditions had decreased posttest pain. The secure (P=.001) and avoidant (P=.001) attachment priming conditions also had lower posttest pain scores relative to the control group. Moreover, social disconnection decreased from pre- to posttest for both the artwork present (P=.04) and the secure attachment priming (P=.002) conditions. Relative to the control group, posttest social disconnection was lower for the artwork present (P=.02) and secure attachment priming condition (P=.03). The artwork-secure attachment (P=.001) and artwork-avoidant attachment (P=.006) conditions had lower posttest pain scores compared with the control group. Social disconnection decreased from pre- to posttest for the artwork-secure attachment (P=.01) and no artwork-secure attachment (P=.05) conditions. Posttest social disconnection was lower for the artwork-secure attachment condition compared with the control group (P=.04). Positive feelings about the social world triggered by artwork exposure and frequency of museum visits in the last year played a mediating and moderating role in these effects. Positive feelings about the social world were associated with decreased pain (B=?.53) and social disconnection (B=?.25), and these effects operated on individuals exposed to digital artwork at low, medium, and high frequency of physical museum visits. Conclusions: Relative to a control group, visiting a web-based art museum reliably decreased pain and social disconnection among individuals living with chronic pain and loneliness. Engaging with digital artwork that triggers positive feelings about the social world may mitigate the burden of chronic pain. Trial Registration: ClinicalTrials.gov NCT05310747; https://clinicaltrials.gov/study/NCT05310747 ", doi="10.2196/52294", url="https://games.jmir.org/2024/1/e52294" } @Article{info:doi/10.2196/55034, author="Warlo, S. Leonie and El Bardai, Souraya and de Vries, Andrica and van Veelen, Marie-Lise and Moors, Suzan and Rings, HHM Edmond and Legerstee, S. Jeroen and Dierckx, Bram", title="Game-Based eHealth Interventions for the Reduction of Fatigue in People With Chronic Diseases: Systematic Review and Meta-Analysis", journal="JMIR Serious Games", year="2024", month="Oct", day="17", volume="12", pages="e55034", keywords="fatigue", keywords="chronic disease", keywords="eHealth", keywords="serious games", keywords="exergames", abstract="Background: Fatigue is a common and debilitating side effect of chronic diseases, significantly impacting patients' quality of life. While physical exercise and psychological treatments have been shown to reduce fatigue, patients often struggle with adherence to these interventions in clinical practice. Game-based eHealth interventions are believed to address adherence issues by making the intervention more accessible and engaging. Objective: This study aims to compile empirical evidence on game-based eHealth interventions for fatigue in individuals with chronic diseases and to evaluate their effectiveness in alleviating fatigue. Methods: A comprehensive literature search was performed across Embase, MEDLINE ALL, PsycINFO, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, and Google Scholar in August 2021. Study characteristics and outcomes from the included studies were extracted, and a random-effects meta-analysis was conducted. Sensitivity and subgroup analyses were performed to identify sources of heterogeneity. Results: Of 1742 studies identified, 17 were included in the meta-analysis. These studies covered 5 different chronic diseases: multiple sclerosis (n=10), cancer (n=3), renal disease (n=2), stroke (n=1), and Parkinson disease (n=1). All but 1 study used exergaming interventions. The meta-analysis revealed a significant moderate effect size in reducing fatigue favoring the experimental interventions (standardized mean difference [SMD] --0.65, 95\% CI --1.09 to --0.21, P=.003) compared with control conditions consisting of conventional care and no care. However, heterogeneity was high (I2=85.87\%). Subgroup analyses were conducted for the 2 most prevalent diseases. The effect size for the multiple sclerosis subgroup showed a trend in favor of eHealth interventions (SMD --0.47, 95\% CI --0.95 to 0.01, P=.05, I2=63.10\%), but was not significant for the cancer group (SMD 0.61, 95\% CI --0.36 to 1.58, P=.22). Balance exercises appeared particularly effective in reducing fatigue (SMD --1.19, 95\% CI --1.95 to --0.42, P=.002). Conclusions: Game-based eHealth interventions appear effective in reducing fatigue in individuals with chronic diseases. Further research is needed to reinforce these findings and explore their impact on specific diseases. Additionally, there is a lack of investigation into interventions beyond exergaming within the field of game-based learning. ", doi="10.2196/55034", url="https://games.jmir.org/2024/1/e55034" } @Article{info:doi/10.2196/58089, author="Elser, Alexander and Kopkow, Christian and Sch{\"a}fer, Georg Axel", title="Implementation of a Virtual Reality Intervention in Outpatient Physiotherapy for Chronic Pain: Protocol for a Pilot Implementation Study", journal="JMIR Res Protoc", year="2024", month="Sep", day="23", volume="13", pages="e58089", keywords="chronic pain", keywords="implementation", keywords="virtual reality", keywords="VR", keywords="physiotherapy", keywords="virtual reality intervention", keywords="pain", keywords="outpatient", keywords="chronic pain conditions", keywords="evidence-based", abstract="Background: Chronic pain is a global health issue that causes physical, psychological, and social disabilities for patients, as well as high costs for societies. Virtual reality (VR) is a new treatment that provides an opportunity to narrow the gap between clinical practice and recommended care in the use of patient education and behavioral interventions in the outpatient physiotherapy setting. However, there is currently no implementation strategy to integrate VR treatments into this setting. Objective: This protocol outlines a pilot implementation study that aims to (1) identify barriers and facilitators for implementing a VR intervention in outpatient physiotherapy care for people with chronic pain and (2) develop and pilot test an implementation strategy in 5 practices in Germany. Methods: The study consists of 4 phases. The first phase involves adapting the treatment protocol of the VR intervention to the local context of outpatient physiotherapy practices in Germany. The second phase includes the collection of barriers and facilitators through semistructured interviews from physiotherapists and the development of a theory-driven implementation strategy based on the Theoretical Domains framework and the Behavior Change Wheel. This strategy will be applied in the third phase, which will also include a 6-month span of using VR interventions in practices, along with a process evaluation. The fourth phase consists of semistructured interviews to evaluate the developed implementation strategy. Results: The recruitment process and phase 1, including the adaptation of the treatment protocol, have already been completed. We recruited 5 physiotherapy practices in Lower Saxony, Germany, where the VR intervention will be implemented. The collection of barriers and facilitators through semistructured interviews is scheduled to begin in February 2024. Conclusions: This pilot implementation study aims to develop a theory-driven implementation strategy for integrating a VR intervention into outpatient physiotherapy care for people with chronic pain. The identified barriers and facilitators, along with the implementation strategy, will serve as a starting point for future randomized controlled implementation studies in different settings to refine the implementation process and integrate VR interventions into the outpatient care of people with chronic pain. Trial Registration: German Clinical Trials Register DRKS00030862; https://tinyurl.com/3zf7uujx International Registered Report Identifier (IRRID): DERR1-10.2196/58089 ", doi="10.2196/58089", url="https://www.researchprotocols.org/2024/1/e58089" } @Article{info:doi/10.2196/48959, author="Orgil, Zandantsetseg and Karthic, Anitra and Bell, F. Nora and Heisterberg, M. Lisa and Williams, E. Sara and Ding, Lili and Kashikar-Zuck, Susmita and King, D. Christopher and Olbrecht, A. Vanessa", title="Use of Biofeedback-Based Virtual Reality in Pediatric Perioperative and Postoperative Settings: Observational Study", journal="JMIR Perioper Med", year="2024", month="Sep", day="16", volume="7", pages="e48959", keywords="virtual reality", keywords="biofeedback", keywords="biofeedback-based virtual reality", keywords="acute pain", keywords="postoperative pain", keywords="pediatrics", keywords="postoperative", keywords="pain", keywords="anxiety", keywords="children", keywords="adolescents", keywords="perioperative management", keywords="acceptability", keywords="feasibility", keywords="pain reduction", abstract="Background: Biofeedback-based virtual reality (VR-BF) is a novel, nonpharmacologic method for teaching patients how to control their breathing, which in turn increases heart rate variability (HRV) and may reduce pain. Unlike traditional forms of biofeedback, VR-BF is delivered through a gamified virtual reality environment, increasing the accessibility of biofeedback. This is the first study to systematically integrate VR-BF use in the pediatric perioperative setting, with the ultimate goal of evaluating the efficacy of VR-BF to reduce pain, anxiety, and opioid consumption once feasibility and acceptability have been established. Objectives: The primary objective was to develop a clinical trial protocol for VR-BF use in the pediatric perioperative setting, including preoperative education and training, and postoperative application of VR-BF in children undergoing surgery. A secondary objective was to evaluate the patient and parent experience with VR-BF. Methods: A total of 23 patients (12-18 years of age) scheduled for surgery at Nationwide Children's Hospital were recruited using purposive sampling. Following training, participants independently completed a daily, 10-minute VR-BF session for 7 days before surgery and during their inpatient stay. Participants could use VR-BF up to 2 weeks after hospital discharge. Patient- and session-level data of VR-BF usage and achievement of target HRV parameters were measured to identify the optimal frequency and duration of sessions before and after surgery for this population. Standardized questionnaires and semistructured interviews were conducted to obtain qualitative information about patients' experiences with VR-BF. Results: Patient-level data indicated that the highest odds of achieving 1 session under target HRV parameters was after 4 sessions (odds ratio [OR] 5.1 for 4 vs 3 sessions, 95\% CI 1.3-20.6; OR 16.6 for 3 vs 2 sessions, 95\% CI 1.2-217.0). Session-level data showed that a session duration of 9 to 10 minutes provided the greatest odds of achieving 1 session under target HRV parameters (OR 1.3 for 9 vs 8 min, 95\% CI 1.1-1.7; OR 1.4 for 8 vs 7 min, 95\% CI 1.1-1.8; OR 1 for 10 vs 9 min, 95\% CI 0.9-1.2). Qualitative data revealed patient satisfaction with the VR-BF technology, particularly in managing perioperative stress (17/20, 85\%). Few patients reported VR-BF as beneficial for pain (8/20, 40\%). Conclusions: Children and adolescents undergoing surgery successfully learned behavioral strategies with VR-BF with 10-minute sessions once daily for 5 days. To integrate VR-BF as a therapeutic intervention in a subsequent clinical trial, patients will be instructed to complete three 10-minute sessions a day for 7 days after surgery. Trial Registration: ClinicalTrials NCT04943874; https://clinicaltrials.gov/ct2/show/NCT04943874 ", doi="10.2196/48959", url="https://periop.jmir.org/2024/1/e48959", url="http://www.ncbi.nlm.nih.gov/pubmed/38742940" } @Article{info:doi/10.2196/48787, author="Lo, Man Hermione Hin and Zhu, Mengting and Zou, Zihui and Wong, Lee Cho and Lo, Shan Suzanne Hoi and Chung, Chi-Ho Vincent and Wong, Yeung-Shan Samuel and Sit, Shan Regina Wing", title="Immersive and Nonimmersive Virtual Reality--Assisted Active Training in Chronic Musculoskeletal Pain: Systematic Review and Meta-Analysis", journal="J Med Internet Res", year="2024", month="Aug", day="19", volume="26", pages="e48787", keywords="virtual reality", keywords="VR", keywords="physical therapy", keywords="musculoskeletal", keywords="pain", keywords="physiotherapy", keywords="chronic pain", keywords="musculoskeletal pain", keywords="low back pain", keywords="neck pain", keywords="osteoarthritis", keywords="knee pain", keywords="shoulder pain", keywords="disability", keywords="kinesiophobia", keywords="arthritis", keywords="systematic", keywords="review methods", keywords="review methodology", keywords="immersive", keywords="simulation", keywords="simulations", abstract="Background: Virtual reality (VR) in different immersive conditions has been increasingly used as a nonpharmacological method for managing chronic musculoskeletal pain. Objective: We aimed to assess the effectiveness of VR-assisted active training versus conventional exercise or physiotherapy in chronic musculoskeletal pain and to analyze the effects of immersive versus nonimmersive VR on pain outcomes. Methods: This systematic review of randomized control trials (RCTs) searched PubMed, Scopus, and Web of Science databases from inception to June 9, 2024. RCTs comparing adults with chronic musculoskeletal pain receiving VR-assisted training were included. The primary outcome was pain intensity; secondary outcomes included functional disability and kinesiophobia. Available data were pooled in a meta-analysis. Studies were graded using the Cochrane Risk-of-Bias Tool version 2. Results: In total, 28 RCTs including 1114 participants with some concerns for a high risk of bias were identified, and 25 RCTs were included in the meta-analysis. In low back pain, short-term outcomes measured post intervention showed that nonimmersive VR is effective in reducing pain (standardized mean difference [SMD] --1.79, 95\% CI --2.72 to --0.87; P<.001), improving disability (SMD --0.44, 95\% CI --0.72 to --0.16; P=.002), and kinesiophobia (SMD --2.94, 95\% CI --5.20 to --0.68; P=.01). Intermediate-term outcomes measured at 6 months also showed that nonimmersive VR is effective in reducing pain (SMD --8.15, 95\% CI --15.29 to --1.01; P=.03), and kinesiophobia (SMD --4.28, 95\% CI --8.12 to --0.44; P=.03) compared to conventional active training. For neck pain, immersive VR reduced pain intensity (SMD --0.55, 95\% CI --1.02 to --0.08; P=.02) but not disability and kinesiophobia in the short term. No statistical significances were detected for knee pain or other pain regions at all time points. In addition, 2 (8\%) studies had a high risk of bias. Conclusions: Both nonimmersive and immersive VR--assisted active training is effective in reducing back and neck pain symptoms. Our study findings suggest that VR is effective in alleviating chronic musculoskeletal pain. Trial Registration: PROSPERO CRD42022302912; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=302912 ", doi="10.2196/48787", url="https://www.jmir.org/2024/1/e48787" } @Article{info:doi/10.2196/53196, author="Gold, I. Jeffrey and Akbar, M. Krystal and Avila, Sandra and Ngo, H. Nhat and Klein, J. Margaret", title="Exploring Relations Between Unique Patient Characteristics and Virtual Reality Immersion Level on Anxiety and Pain in Patients Undergoing Venipuncture: Secondary Analysis of a Randomized Control Trial", journal="J Med Internet Res", year="2024", month="Jul", day="1", volume="26", pages="e53196", keywords="pediatrics", keywords="virtual reality", keywords="VR", keywords="immersion", keywords="anxiety", keywords="pain management", keywords="routine medical procedures", keywords="venipuncture", keywords="secondary data analysis", keywords="mediation", keywords="moderation", keywords="pain", keywords="acute pain", keywords="pediatric pain", keywords="anxiety sensitivity", abstract="Background: Virtual reality (VR) is a well-researched digital intervention that has been used for managing acute pain and anxiety in pediatric patients undergoing various medical procedures. This study focuses on investigating the role of unique patient characteristics and VR immersion level on the effectiveness of VR for managing pediatric pain and anxiety during venipuncture. Objective: The purpose of this study is to determine how specific patient characteristics and level of immersion during a VR intervention impact anxiety and pain levels for pediatric patients undergoing venipuncture procedures. Methods: This study is a secondary data analysis of 2 combined, previously published randomized control trials on 252 pediatric patients aged 10-21 years observed at Children's Hospital Los Angeles from April 12, 2017, to July 24, 2019. One randomized clinical trial was conducted in 3 clinical environments examining peripheral intravenous catheter placement (radiology and an infusion center) and blood draw (phlebotomy). Conditional process analysis was used to conduct moderation and mediation analyses to assess the impact of immersion level during the VR intervention. Results: Significant moderation was found between the level of immersion and anxiety sensitivity when predicting postprocedural anxiety (P=.01). Patients exhibiting the highest anxiety sensitivity within the standard of care yielded a 1.9 (95\% CI 0.9-2.8; P<.001)-point elevation in postprocedural anxiety relative to individuals with high immersion levels. No other significant factors were found to mediate or moderate the effect of immersion on either postprocedural anxiety or pain. Conclusions: VR is most effective for patients with higher anxiety sensitivity who report feeling highly immersed. Age, location of the procedure, and gender of the patient were not found to significantly impact VR's success in managing levels of postprocedural pain or anxiety, suggesting that immersive VR may be a beneficial intervention for a broad pediatric population. Trial Registration: ClinicalTrials.gov NCT04268901; https://clinicaltrials.gov/study/NCT04268901 ", doi="10.2196/53196", url="https://www.jmir.org/2024/1/e53196", url="http://www.ncbi.nlm.nih.gov/pubmed/38949862" } @Article{info:doi/10.2196/42829, author="Guo, Qifan and Zhang, Liming and Han, Lianyi Leo and Gui, Chenfan and Chen, Guanghui and Ling, Chunyan and Wang, Wei and Gao, Qiang", title="Effects of Virtual Reality Therapy Combined With Conventional Rehabilitation on Pain, Kinematic Function, and Disability in Patients With Chronic Neck Pain: Randomized Controlled Trial", journal="JMIR Serious Games", year="2024", month="Apr", day="24", volume="12", pages="e42829", keywords="virtual reality", keywords="neck pain", keywords="disability", keywords="kinematic function", keywords="rehabilitation", keywords="physiotherapy", keywords="neck", keywords="pain", keywords="chronic", keywords="therapy", keywords="kinematic", keywords="efficacy", keywords="patient", keywords="effect", abstract="Background: Neck pain is a common condition that leads to neck motor dysfunction and subsequent disability, with a significant global health care burden. As a newly emerging tool, virtual reality (VR) technology has been employed to address pain and reduce disability among patients with neck pain. However, there is still a lack of high-quality studies evaluating the efficacy of VR therapy combined with conventional rehabilitation for patients with chronic neck pain, particularly in terms of kinematic function. Objective: This study aims to investigate the effect of VR therapy combined with conventional rehabilitation on pain, kinematic function, and disability in patients with chronic neck pain. Methods: We conducted an assessor-blinded, allocation-concealed randomized controlled trial. Sixty-four participants experiencing chronic neck pain were randomly allocated into the experimental group that underwent VR rehabilitation plus conventional rehabilitation or the control group receiving the same amount of conventional rehabilitation alone for 10 sessions over 4 weeks. Pain intensity, disability, kinematic function (cervical range of motion, proprioception, and mean and peak velocity), degree of satisfaction, and relief of symptoms were evaluated at 3 timepoints (baseline, postintervention, and at 3 months follow-up). A 2*3 mixed repeated measures analysis of variance was utilized for analyzing the difference across indicators, with a significant difference level of .05. Results: Both groups demonstrated significant improvements in pain, disability, and kinematic functions (P<.05) at postintervention and at 3-month follow-up. The experimental group showed superior therapeutic outcomes compared to the control group in pain reduction (mean difference from the baseline: 5.50 vs 1.81 at posttreatment; 5.21 vs 1.91 at the 3-month follow-up, respectively; P<.001), disability improvement (mean difference from baseline: 3.04 vs 0.50 at posttreatment; 3.20 vs 0.85 at the 3-month follow-up, respectively; P<.001), and enhanced kinematic functions (P<.05). Moreover, participants in the experimental group reported better satisfaction and relief of symptoms than the control group (P<.05), with better initiative for exercising during the follow-up period. However, there was no between-group difference of improvement in proprioception. No adverse events were reported or observed in our research. Conclusions: The findings of our study support the efficacy of combining VR therapy with conventional rehabilitation in alleviating pain, enhancing kinematic function, and reducing disability of patients with chronic neck pain. Future research should focus on refining the therapeutic protocols and dosages for VR therapy as well as on optimizing its application in clinical settings for improved convenience and effectiveness. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000040132; http://www.chictr.org.cn/showproj.aspx?proj=64346 ", doi="10.2196/42829", url="https://games.jmir.org/2024/1/e42829", url="http://www.ncbi.nlm.nih.gov/pubmed/38656775" } @Article{info:doi/10.2196/50089, author="Zhang, Tongtong and Li, Xin and Zhou, Xuan and Zhan, Lixia and Wu, Fan and Huang, Zefan and Sun, Yuxun and Feng, Yufei and Du, Qing", title="Virtual Reality Therapy for the Management of Chronic Spinal Pain: Systematic Review and Meta-Analysis", journal="JMIR Serious Games", year="2024", month="Feb", day="12", volume="12", pages="e50089", keywords="virtual reality", keywords="chronic spinal pain", keywords="inflammation-related pain", keywords="systematic review", keywords="meta-analysis", abstract="Background: The effectiveness of virtual reality (VR) therapy in adults with chronic spinal pain (CSP) is unclear. Objective: This study was conducted to compare the effectiveness of VR therapy and other therapies in adults with CSP, especially patients with inflammation-related pain. Methods: PubMed, Web of Science, Cochrane Library, Embase, and CINAHL databases were searched up to November 11, 2023. Randomized controlled trials (RCTs) comparing adults with CSP receiving VR therapy with those receiving other therapies were included. The trial registration platform as well as the reference lists of included studies and previous systematic reviews and meta-analyses were manually searched. Two independent reviewers performed study selection, data extraction, risk-of-bias assessment, and evaluation of the quality of the evidence. The weighted mean difference (WMD) was used as the effect size used to synthesize the outcome measure. Results: In total, 16 RCTs involving 800 participants were included in this meta-analysis. The pooled data from 15 (94\%) RCTs including 776 (97\%) participants showed that VR therapy was superior in improving pain intensity (WMD=--1.63, 95\% CI --2.11 to --1.16, P<.001, I2=90\%) and reducing inflammatory markers, including C-reactive protein (WMD=--0.89, 95\% CI --1.07 to --0.70, P<.001, I2=0\%), tumor necrosis factor-alpha (WMD=--6.60, 95\% CI --8.56 to --4.64, P<.001, I2=98\%), and interleukin-6 (WMD=--2.76, 95\% CI --2.98 to --2.53, P<.001, I2=0\%). However, no significant differences were found in terms of the spinal range of motion (ROM), disability level, or fear of movement. In addition, 10 (63\%) of the included RCTs had a high risk of bias. Conclusions: VR therapy may be an effective and safe intervention for reducing symptoms in patients with CSP, as it is shown to exert significant analgesic effects and beneficial improvements in inflammatory factor levels. However, this approach may not have significant effects on the spinal ROM, disability level, or fear of movement. Notably, the quality of the evidence from the RCTs included in this study ranged from moderate to low. Therefore, we recommend that readers interpret the results of this study with caution. Trial Registration: PROSPERO CRD42022382331; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=382331 ", doi="10.2196/50089", url="https://games.jmir.org/2024/1/e50089", url="http://www.ncbi.nlm.nih.gov/pubmed/38345832" } @Article{info:doi/10.2196/48354, author="Yang, Xun and Zhong, Sen and Yang, Sheng and He, Meng and Xu, Xu and He, Shisheng and Fan, Guoxin and Liu, Lijun", title="Global Scientific Trends in Virtual Reality for Pain Treatment From 2000 to 2022: Bibliometric Analysis", journal="JMIR Serious Games", year="2023", month="Nov", day="14", volume="11", pages="e48354", keywords="virtual reality", keywords="pain management", keywords="bibliometrics", keywords="research trends", keywords="CiteSpace", keywords="VOSviewer", abstract="Background: Virtual reality (VR) is a computer simulation technique that has been increasingly applied in pain management over the past 2 decades. Objective: In this study, we used bibliometrics to explore the literature on VR and pain control, with the aim of identifying research progress and predicting future research hot spots. Methods: We extracted literature on VR and pain control published between 2000 and 2022 from the Web of Science Core Collections and conducted bibliometric analyses. We analyzed the publication and citation trends in the past 2 decades, as well as publication and citation analyses of different countries, institutions, journals, and authors. For references, we conducted cocitation and burst analyses. For keywords, we conducted co-occurrence, clustering, timeline view, and citation burst analyses. Results: Based on 1176 publications, we found that there was a continuous increase in publication and citation volumes, especially in the last 5 years. The United States was the most representative country, and the University of Washington was the most representative institution, with both having the most publications and citations. The most popular journal in this field was Burns, and Hoffman HG was the most productive author, leading many studies on patients with burn pain. The reference with the most citation burst was a study on the verification of new hardware in pain control. The keywords with the highest citation bursts related to various situations of pain such as ``burn pain,'' ``wound care,'' ``low back pain,'' and ``phantom limb.'' Conclusions: VR has been applied in various clinical situations for pain management, among which burns and pediatric surgery have achieved satisfactory results. We infer that VR will be extended to more clinical pain situations in the future, such as pain control in wound care, low back pain, and phantom limb pain. New research hot spots will include the development of software and hardware to improve the immersive experience of VR for pain control. However, our work was based solely on English literature from the Web of Science database. For future studies, we recommend that researchers explore literature from multiple databases to enhance the scope of their research. ", doi="10.2196/48354", url="https://games.jmir.org/2023/1/e48354" } @Article{info:doi/10.2196/47541, author="Ummels, Darcy and Cnockaert, Elise and Timmers, Inge and den Hollander, Marlies and Smeets, Rob", title="Use of Virtual Reality in Interdisciplinary Multimodal Pain Treatment With Insights From Health Care Professionals and Patients: Action Research Study", journal="JMIR Rehabil Assist Technol", year="2023", month="Nov", day="10", volume="10", pages="e47541", keywords="virtual reality", keywords="interdisciplinary multimodal pain treatment", keywords="chronic pain", keywords="pain", keywords="rehabilitation", keywords="digital health", keywords="physiotherapy", keywords="occupational therapy", keywords="physical therapy", abstract="Background: Chronic pain is a widespread global health problem. Interdisciplinary multimodal pain treatment (IMPT) is a treatment option for people with chronic pain. Virtual reality (VR) could be used to broaden IMPT programs. However, despite the advantages of VR, it is rarely used in daily clinical practice. Objective: This research aimed to explore how, when, and with whom VR can be used meaningfully during IMPT, either as an addition or substitution as a component of IMPT. Methods: This research used an action research design to help health care professionals and patients learn how, when, and with whom they can use VR. Data were collected through reflection sessions with health care professionals and semistructured interviews with patients in 2 specialized centers that provide IMPT for chronic pain. Two researchers performed direct content analyses. Results: In total, 4 physiotherapists, 1 occupational therapist, 3 psychologists, and 22 patients participated in this research. Three iteration cycles, including 9 reflection sessions and 8 semistructured interviews, were performed. Both health care professionals and patients considered VR to be useful in therapy as an addition but not a substitution. VR was used as a diagnostic and intervention tool with all patients at the rehabilitation center or home. VR was used to gain insight into patients' pain beliefs, cognitions, and irrational cognitions about additional damage and physical abilities. Considering VR as an intervention tool, the health care professionals had 3 goals: balancing relaxation and competition, grading activities, and exposure in vivo. Conclusions: VR could be a valuable addition to IMPT for both patients with chronic pain and health care professionals. More research should be performed to assess the additional effects of VR on patients' participation in daily life. ", doi="10.2196/47541", url="https://rehab.jmir.org/2023/1/e47541", url="http://www.ncbi.nlm.nih.gov/pubmed/37948109" } @Article{info:doi/10.2196/40044, author="Dy, Marika and Olazo, Kristan and Lisker, Sarah and Brown, Ellenor and Saha, Anindita and Weinberg, Jessica and Sarkar, Urmimala", title="Virtual Reality for Chronic Pain Management Among Historically Marginalized Populations: Systematic Review of Usability Studies", journal="J Med Internet Res", year="2023", month="Jun", day="6", volume="25", pages="e40044", keywords="virtual reality", keywords="chronic pain management", keywords="systematic review", keywords="historically marginalized populations", keywords="VR", keywords="usability", keywords="pain management", keywords="pain", keywords="chronic pain", abstract="Background: Virtual reality (VR) has potential to improve chronic pain management outcomes. However, the majority of studies assessing VR are conducted in predominantly White populations in well-resourced settings, thus leaving a gap in knowledge of VR use among diverse populations who experience a significant chronic pain burden. Objective: This review aims to examine the extent to which usability of VR for chronic pain management has been studied within historically marginalized patient groups. Methods: We conducted a systematic search to identify studies with usability outcomes located in high-income countries that included a historically marginalized population, defined by a mean age greater than or equal to 65 years, lower educational attainment (greater than or equal to 60\% having attained high school education or less), and being a racial or ethnic minority (less than or equal to 50\% non-Hispanic White people for studies based in the United States). Results: Our analysis included 5 papers, which we used to conduct a narrative analysis. Three studies examined VR usability as a primary outcome. All studies assessed VR usability using different measures, of which 4 found VR to be usable by their respective study population. Only 1 study found a significant improvement in pain levels post--VR intervention. Conclusions: The use of VR shows promise for chronic pain management, but few studies include populations that are older, have limited educational attainment, or have racial or ethnic diversity. Additional studies with these populations are needed to further develop VR systems that work best for diverse patients with chronic pain. ", doi="10.2196/40044", url="https://www.jmir.org/2023/1/e40044", url="http://www.ncbi.nlm.nih.gov/pubmed/37279039" } @Article{info:doi/10.2196/42944, author="Mo, Nan and Feng, yu Jin and Liu, xia Hai and Chen, yu Xiao and Zhang, Hui and Zeng, Hui", title="Effects of Exergaming on Musculoskeletal Pain in Older Adults: Systematic Review and Meta-analysis", journal="JMIR Serious Games", year="2023", month="Apr", day="25", volume="11", pages="e42944", keywords="aged", keywords="exergaming", keywords="pain", keywords="review", keywords="video game", keywords="virtual reality", abstract="Background: Exercise is effective for musculoskeletal pain. However, physical, social, and environmental factors make it difficult for older adults to persist in exercising. Exergaming is a new pathway that combines exercise with gameplay and may be helpful for older adults to overcome these difficulties and engage in regular exercise. Objective: This systematic review aimed to determine the efficacy of exergaming to improve musculoskeletal pain in older adults. Methods: The search was performed in 5 databases (PubMed, Embase, CINAHL, Web of Science, and Cochrane Library). The risk of bias for randomized controlled studies was assessed using the revised Cochrane Risk of Bias tool in randomized trials (RoB 2), and the methodological quality was assessed using the Physiotherapy Evidence-Based Database scale. Standardized mean difference and 95\% CI were calculated using fixed-effects model meta-analyses in the Review Manager version 5.3 (RevMan 5.3). Results: Seven randomized controlled studies were included, which contained 264 older adults. Three of the 7 studies reported significant improvements in pain after the exergaming intervention, but only 1 reported a significant difference between groups after adjustment for baseline (P<.05), and another reported a significant improvement in thermal pain between the 2 groups (P<.001). The results of the meta-analysis of the 7 studies showed no statistically significant improvement in pain compared to the control group (standardized mean difference --0.22; 95\% CI --0.47 to 0.02; P=.07). Conclusions: Although the effects of exergames on musculoskeletal pain in older adults are unknown, exergame training is generally safe, fun, and appealing to older adults. Unsupervised exercise at home is feasible and cost-effective. However, most of the current studies have used commercial exergames, and it is recommended that there should be more cooperation between industries in the future to develop professional rehabilitation exergames that are more suitable for older adults. The sample sizes of the studies included are small, the risk of bias is high, and the results should be interpreted with caution. Further randomized controlled studies with large sample sizes, high quality, and rigor are needed in the future. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022342325; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=342325 ", doi="10.2196/42944", url="https://games.jmir.org/2023/1/e42944", url="http://www.ncbi.nlm.nih.gov/pubmed/37097717" } @Article{info:doi/10.2196/36695, author="Xu, Nuo and Chen, Sijing and Liu, Yan and Jing, Yuewen and Gu, Ping", title="The Effects of Virtual Reality in Maternal Delivery: Systematic Review and Meta-analysis", journal="JMIR Serious Games", year="2022", month="Nov", day="23", volume="10", number="4", pages="e36695", keywords="virtual reality technology", keywords="delivery", keywords="labor pain", keywords="anxiety", keywords="meta-analysis", keywords="systematic review", keywords="pain", keywords="pregnancy", keywords="virtual reality", keywords="maternity", keywords="labor", keywords="technology", keywords="pregnant women", keywords="review", keywords="childbirth", keywords="mental health", abstract="Background: Extreme labor pain has negative effects; pharmacologic analgesic modalities are effective but are accompanied by adverse effects. Virtual reality (VR) works as a distracting nonpharmacologic intervention for pain and anxiety relief; however, the effects of VR use in laboring women is unknown. Objective: Our study aimed to determine the safety and effectiveness of VR technology during labor and delivery and investigate whether it impacts labor and patient satisfaction. Methods: In all, 7 databases (PubMed, Embase, Web of Science, the Cochrane Library, CINAHL, China National Knowledge Infrastructure, and Wan-Fang Database) were systematically searched for randomized controlled trials of VR use in pregnancy and childbirth from the time of database construction until November 24, 2021. Two researchers extracted data and evaluated study quality using the Cochrane Risk of Bias tool 2.0. Outcome measures were labor pain, anxiety, duration, satisfaction, and adverse events. Meta-analyses were performed where possible. Results: A total of 12 studies with 1095 participants were included, of which 1 and 11 studies were rated as ``Low risk'' and ``Some concerns'' for risk of bias, respectively. Of the 12 studies, 11 reported labor pain, 7 reported labor anxiety, and 4 reported labor duration. Meta-analysis revealed that VR use could relieve pain during labor (mean difference --1.81, 95\% CI --2.04 to --1.57; P<.001) and the active period (standardized mean difference [SMD] --0.41, 95\% CI --0.68 to --0.14; P=.003); reduce anxiety (SMD --1.39, 95\% CI --1.99 to --0.78; P<.001); and improve satisfaction with delivery (relative risk 1.32, 95\% CI 1.10-1.59; P=.003). The effects of VR on the duration of the first (SMD --1.12, 95\% CI --2.38 to 0.13; P=.08) and second (SMD --0.22, 95\% CI --0.67 to 0.24; P=.35) stages of labor were not statistically significant. Conclusions: VR is safe and effective in relieving maternal labor pain and anxiety; however, due to the heterogeneity among studies conducted to date, more rigorous, large-scale, and standardized randomized controlled trials are required to provide a higher-quality evidence base for the use of VR technology in maternal labor, with the aim of improving experience and outcomes. Trial Registration: PROSPERO CRD42021295410; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=295410 ", doi="10.2196/36695", url="https://games.jmir.org/2022/4/e36695", url="http://www.ncbi.nlm.nih.gov/pubmed/36416881" } @Article{info:doi/10.2196/33221, author="Soret, Lou and Gendron, Nicolas and Rivet, Nadia and Chocron, Richard and Macraigne, Laure and Clausse, Darless and Cholley, Bernard and Gaussem, Pascale and Smadja, M. David and Darnige, Luc", title="Pain Assessment Using Virtual Reality Facemask During Bone Marrow Aspiration: Prospective Study Including Propensity-Matched Analysis", journal="JMIR Serious Games", year="2022", month="Oct", day="12", volume="10", number="4", pages="e33221", keywords="bone marrow aspiration", keywords="pain assessment", keywords="virtual reality facemask", keywords="anxiety", keywords="hematology", keywords="virtual reality", keywords="VR", keywords="haematology", keywords="haematological", keywords="hematological", keywords="hematological disorder", keywords="pain", keywords="pain scale", keywords="medical procedure", keywords="bone marrow", keywords="facemask", keywords="diagnosis", keywords="monitoring", abstract="Background: Bone marrow aspiration (BMA) is a medical procedure necessary to the diagnosis and monitoring of patients with hematological or nonhematological disorders. This procedure is considered painful, and patients are generally anxious before and during BMA. Objective: This study assesses the effect of immersive virtual reality on pain during BMA. Methods: This observational prospective and monocentric study enrolled 105 consecutive patients who underwent sternal BMA with lidocaine anesthesia. The study was carried on during 2 periods. First, virtual reality facemask (VRF) was proposed to all patients in the absence of exclusion criteria. During the second period, BMA was performed without the VRF. For all patients, pain intensity after the procedure was assessed using a 10-point numerical pain rating scale (NPRS). All analyses were performed on propensity score--matched cohort (with or without VRF) to evaluate efficacy on NRPS levels. Results: The final matched cohort included 12 patients in the VRF group and 24 in the control group. No difference in anxiety level before BMA evaluated by the patient and by the operator was observed between groups (P=.71 and .42 respectively). No difference of NPRS was observed using VRF when compared to control group (median NPRS 3.8, IQR 2.0-6.3 vs 3.0, IQR 1.9-3.0, respectively; P=.09). Conclusions: Our study did not prove the efficacy of VRF to reduce pain during BMA. ", doi="10.2196/33221", url="https://games.jmir.org/2022/4/e33221", url="http://www.ncbi.nlm.nih.gov/pubmed/36222814" } @Article{info:doi/10.2196/31685, author="Meinke, Anita and Peters, Rick and Knols, H. Ruud and Swanenburg, Jaap and Karlen, Walter", title="Feedback on Trunk Movements From an Electronic Game to Improve Postural Balance in People With Nonspecific Low Back Pain: Pilot Randomized Controlled Trial", journal="JMIR Serious Games", year="2022", month="Jun", day="10", volume="10", number="2", pages="e31685", keywords="low back pain", keywords="postural balance", keywords="exergame", keywords="postural feedback", keywords="motor control", keywords="kinesiophobia", keywords="inertial measurement unit", keywords="randomized controlled trial", abstract="Background: Postural balance is compromised in people with low back pain, possibly by changes in motor control of the trunk. Augmenting exercising interventions with sensor-based feedback on trunk posture and movements might improve postural balance in people with low back pain. Objective: We hypothesized that exercising with feedback on trunk movements reduces sway in anterior-posterior direction during quiet standing in people with low back pain. Secondary outcomes were lumbar spine and hip movement assessed during box lift and waiter bow tasks, as well as participant-reported outcomes. Adherence to the exercising intervention was also examined. Methods: A randomized controlled trial was conducted with the intervention group receiving unsupervised home exercises with visual feedback using the Valedo Home, an exergame based on 2 inertial measurement units. The control group received no intervention. Outcomes were recorded by blinded staff during 4 visits (T1-T4) at University Hospital Zurich. The intervention group performed 9 sessions of 20 minutes in the 3 weeks between T2 and T3 and were instructed to exercise at their own convenience between T3 and T4. Postural balance was assessed on a force platform. Lumbar spine and hip angles were obtained from 3 inertial measurement units. The assessments included pain intensity, disability, quality of life, and fear of movement questionnaires. Results: A total of 32 participants with nonspecific low back pain completed the first assessment T1, and 27 (84\%) participants were randomized at T2 (n=14, 52\% control and n=13, 48\% intervention). Intention-to-treat analysis revealed no significant difference in change in anterior-posterior sway direction during the intervention period with a specified schedule (T2-T3) between the groups (W=99; P=.36; r=0.07). None of the outcomes showed significant change in accordance with our hypotheses. The intervention group completed a median of 61\% (55/90; range 2\%-99\%) of the exercises in the predefined training program. Adherence was higher in the first intervention period with a specified schedule. Conclusions: The intervention had no significant effect on postural balance or other outcomes, but the wide range of adherence and a limited sample size challenged the robustness of these conclusions. Future work should increase focus on improving adherence to digital interventions. Trial Registration: ClinicalTrials.gov NCT04364243; https://clinicaltrials.gov/ct2/show/NCT04364243 International Registered Report Identifier (IRRID): RR2-10.2196/26982 ", doi="10.2196/31685", url="https://games.jmir.org/2022/2/e31685", url="http://www.ncbi.nlm.nih.gov/pubmed/35687390" } @Article{info:doi/10.2196/34402, author="Goudman, Lisa and Jansen, Julie and Billot, Maxime and Vets, Nieke and De Smedt, Ann and Roulaud, Manuel and Rigoard, Philippe and Moens, Maarten", title="Virtual Reality Applications in Chronic Pain Management: Systematic Review and Meta-analysis", journal="JMIR Serious Games", year="2022", month="May", day="10", volume="10", number="2", pages="e34402", keywords="virtual reality", keywords="chronic pain", keywords="systematic review", keywords="multilevel meta-analysis", keywords="immersive technologies", keywords="clinical outcomes", keywords="mobile phone", abstract="Background: Virtual reality (VR) is a computer technology that immerses a user in a completely different reality. The application of VR in acute pain settings is well established. However, in chronic pain, the applications and outcome parameters influenced by VR are less clear. Objective: This review aimed to systematically identify all outcome parameters that are reported in relation to VR in patients with chronic pain. Methods: A total of 4 electronic databases (PubMed, Scopus, Web of Science, and Embase) were searched for relevant studies. Multilevel random-effect meta-analyses were performed, whereby the standardized mean difference was chosen as the effect size to denote the difference between measurements before and after a VR intervention. Results: The initial database search identified 1430 studies, of which 41 (2.87\%) were eventually included in the systematic review. Evidence has been found for the effects of VR on pain, functioning, mobility, functional capacity, psychological outcomes, quality of life, neuropsychological outcomes, and physical sensations. The overall effect size (a total of 194 effect sizes from 25 studies) based on a three level meta-analysis was estimated at 1.22 (95\% CI 0.55-1.89; z=3.56; P<.001), in favor of improvements after a VR intervention. When categorizing effect sizes, the overall effect sizes were reported as follows: 1.60 (95\% CI 0.83-2.36; z=4.09; P<.001) for the effect of VR on pain (n=31), 1.40 (95\% CI 0.13-2.67; z=2.17; P=.03) for functioning (n=60), 0.49 (95\% CI ?0.71 to 1.68; z=0.80; P=.42) for mobility (n=24), and 0.34 (95\% CI ?1.52 to 2.20; z=0.36; P=.72) for functional capacity (n=21). Conclusions: This systematic review revealed a broad range of outcome variables influenced by an intervention of VR technology, with statistically significant pain relief and improvements in functioning. These findings indicate that VR not only has applications in acute pain management but also in chronic pain settings, whereby VR might be able to become a promising first-line intervention as complementary therapy for patients with chronic pain. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021227016; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=227016 ", doi="10.2196/34402", url="https://games.jmir.org/2022/2/e34402", url="http://www.ncbi.nlm.nih.gov/pubmed/35536641" } @Article{info:doi/10.2196/30260, author="Hoag, A. Jennifer and Karst, Jeffrey and Bingen, Kristin and Palou-Torres, Akasha and Yan, Ke", title="Distracting Through Procedural Pain and Distress Using Virtual Reality and Guided Imagery in Pediatric, Adolescent, and Young Adult Patients: Randomized Controlled Trial", journal="J Med Internet Res", year="2022", month="Apr", day="18", volume="24", number="4", pages="e30260", keywords="virtual reality", keywords="procedural", keywords="pain", keywords="anxiety", keywords="pediatric", keywords="guided imagery", abstract="Background: Children with acute and chronic illness undergo frequent, painful, and distressing procedures. Objective: This randomized controlled trial was used to evaluate the effectiveness of guided imagery (GI) versus virtual reality (VR) on the procedural pain and state anxiety of children and young adults undergoing unsedated procedures. We explored the role of trait anxiety and pain catastrophizing in intervention response. Methods: Children and young adults were recruited from the hematology, oncology, and blood and marrow transplant clinics at a children's hospital. Each study participant completed the GI and VR intervention during separate but consecutive unsedated procedures. Self-report measures of pain and anxiety were completed before and after the procedures. Results: A total of 50 participants (median age 13 years) completed both interventions. GI and VR performed similarly in the management of procedural pain. Those with high pain catastrophizing reported experiencing less nervousness about pain during procedures that used VR than those using GI. State anxiety declined pre- to postprocedure in both interventions; however, the decrease reached the level of significance during the VR intervention only. Those with high trait anxiety had less pain during GI. Conclusions: In our sample, VR worked as well as GI to manage the pain and distress associated with common procedures experienced by children with acute or chronic illnesses. Children who are primed for pain based on beliefs about pain or because of their history of chronic pain had a better response to VR. GI was a better intervention for those with high trait anxiety. Trial Registration: ClinicalTrials.gov NCT04892160; https://clinicaltrials.gov/ct2/show/NCT04892160 ", doi="10.2196/30260", url="https://www.jmir.org/2022/4/e30260", url="http://www.ncbi.nlm.nih.gov/pubmed/35436209" } @Article{info:doi/10.2196/31404, author="Beltran-Alacreu, Hector and Navarro-Fern{\'a}ndez, Gonzalo and Godia-Lled{\'o}, Daniela and Graell-Pasar{\'o}n, Lucas and Ramos-Gonz{\'a}lez, {\'A}lvaro and Raya, Rafael and Martin-Pintado Zugasti, Aitor and Fernandez-Carnero, Josue", title="A Serious Game for Performing Task-Oriented Cervical Exercises Among Older Adult Patients With Chronic Neck Pain: Development, Suitability, and Crossover Pilot Study", journal="JMIR Serious Games", year="2022", month="Feb", day="1", volume="10", number="1", pages="e31404", keywords="video games", keywords="neck pain", keywords="aged", keywords="virtual reality", keywords="exercise therapy", keywords="physical therapy modalities", keywords="technology", abstract="Background: There is sparse research on the effectiveness of therapeutic exercise for the treatment of neck pain in older adult populations. Moreover, there is a lack of research on the use of serious games or virtual reality for the treatment of neck pain in this population. Objective: The primary aim of this study was to develop and assess the suitability of a serious game for performing task-oriented cervical exercises in patients with neck pain. Methods: A serious game was designed based on the key features identified by previous studies that designed serious video games for physical and cognitive rehabilitation or exercise. The game in this study was designed to provide an interactive scenario, with the main functionality of the software solution to control a virtual airplane to reach targets using head motions. At the end of the exercise, the application stores the targets reached and missed and the airplane's trajectory. A crossover pilot study was carried out for preliminary evaluation of the suitability of the technology in the older adult population. Men and women over 65 years of age with chronic neck pain were included. Subjects were randomly assigned to two study arms; each arm consisted of a sequence of two 4-week treatments with an intermediate washout period of 4 weeks. The total study duration was 16 weeks due to a final follow-up measure 4 weeks after the end of all treatments. Treatment A consisted of the use of the serious game developed in this study, and treatment B consisted of conventional exercises. Subjects allocated to the A-B study arm received treatment A first, followed by treatment B, and vice versa in the B-A arm. The following variables were assessed: Suitability Evaluation Questionnaire (SEQ) scores, Visual Analog Scale scores, and the number of targets reached in the serious game. Results: A total of 18 subjects were assessed for eligibility. A total of 13 subjects, aged between 71 and 92 years (mean 81.85, SD 6.82), were finally included and completed the study protocol. The global mean SEQ score was 50.38 (SD 5.35) out of 65 points, showing good suitability of the serious game. Most patients considered the experience very enjoyable and ``real'' in terms of the virtual environment and found the information provided to be clear. Also, they believed that the game could be very helpful for their rehabilitation. None of the patients felt any neck pain or discomfort when playing the game, and only 2 patients out of 13 (15\%) reported some degree of dizziness, eye discomfort, or disorientation, which did not limit their capacity to finish the session. Conclusions: The serious game developed in this study showed good suitability for use in adults over 70 years of age with chronic neck pain. The game was a safe method for performing task-oriented cervical exercises, and patients reported very high levels of satisfaction and acceptance after the use of this technology. ", doi="10.2196/31404", url="https://games.jmir.org/2022/1/e31404", url="http://www.ncbi.nlm.nih.gov/pubmed/35103608" } @Article{info:doi/10.2196/26982, author="Meinke, Anita and Peters, Rick and Knols, Ruud and Karlen, Walter and Swanenburg, Jaap", title="Exergaming Using Postural Feedback From Wearable Sensors and Exercise Therapy to Improve Postural Balance in People With Nonspecific Low Back Pain: Protocol for a Factorial Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2021", month="Aug", day="26", volume="10", number="8", pages="e26982", keywords="low back pain", keywords="exercise therapy", keywords="postural balance", keywords="postural feedback", keywords="motor control", keywords="fear of movement", keywords="exergame", keywords="randomized controlled trial", keywords="physical activity", keywords="smartphone", keywords="sensors", keywords="activity tracker", keywords="mobile phone", abstract="Background: Physical exercise is a common treatment for people with low back pain (LBP). Wearable sensors that provide feedback on body movements and posture during exercise may enhance postural balance and motor control in people with LBP. Objective: This study aims to investigate whether physical exercising with postural feedback (EPF) improves postural balance, motor control, and patient-reported outcomes in people with LBP. Methods: The study was an assessor-blinded 2{\texttimes}2 factorial trial. We planned to recruit 80 participants with nonspecific LBP who did not receive treatment for LBP. In addition, we aimed to recruit 40 patients with chronic, nonspecific LBP who were receiving exercise therapy (ET) at the University Hospital Zurich. Both ET patients and participants without treatment were randomized to receive either an additional EPF intervention or no additional intervention. This resulted in four different combinations of interventions: ET+EPF, ET, EPF, and no intervention. The participants underwent outcome assessments at inclusion (T1); 3 weeks later, at randomization (T2); after an intervention period of 3 weeks with a predefined exercise schedule for participants receiving EPF (T3); and after an additional 6 weeks, during which participants assigned to the EPF groups could exercise as much as they wished (T4). Patients receiving ET completed their regularly prescribed therapies during the study period. Balance was assessed during quiet standing on a force platform, and motor control was assessed during a lifting task and a waiter's bow task. Physical activity was recorded using an activity tracker and the participants' mobile phones during the study. The predefined EPF schedule consisted of nine sessions of 20 minutes of exercise with a tablet and inertial measurement unit sensors at home. Participants performed a series of trunk and hip movements and received feedback on their movements in a gamified environment displayed on the tablet. Results: The first participant was recruited in May 2019. Data collection was completed in October 2020, with 3 patients and 32 eligible people without therapy who passed the eligibility check. Conclusions: Although it will not be possible to investigate differences in patients and people without other therapies, we expect this pilot study to provide insights into the potential of EPF to improve balance in people with LBP and adherence to such interventions. International Registered Report Identifier (IRRID): DERR1-10.2196/26982 ", doi="10.2196/26982", url="https://www.researchprotocols.org/2021/8/e26982", url="http://www.ncbi.nlm.nih.gov/pubmed/34435954" } @Article{info:doi/10.2196/26040, author="Canares, Therese and Parrish, Carisa and Santos, Christine and Badawi, Alia and Stewart, Alyssa and Kleinman, Keith and Psoter, Kevin and McGuire, Joseph", title="Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial", journal="JMIR Pediatr Parent", year="2021", month="Jul", day="28", volume="4", number="3", pages="e26040", keywords="pediatrics", keywords="psychological distress", keywords="virtual reality", keywords="procedural pain", keywords="anxiety", keywords="phlebotomy", abstract="Background: Virtual reality (VR) has shown promise in reducing children's pain and anxiety during venipuncture, but studies on VR lack objective observations of pediatric coping. Notably, the process of capturing objective behavioral coping data can be labor- and personnel-intensive. Objective: The primary aims of this pilot trial were to assess the feasibility of conducting a trial of VR in a pediatric emergency department and the feasibility of documenting observed coping behaviors during pediatric procedures. Secondarily, this study examined whether VR affects child and caregiver coping and distress during venipuncture in the pediatric emergency department. Methods: This stratified, randomized, controlled pilot trial compared coping and distress between child life--supported VR engagement and child life specialist support without VR during painful procedures in children aged 7-22 years in the pediatric emergency department. An external control (reference group) received no standardized support. Primary feasibility outcomes included rates of recruitment, rates of withdrawal from VR, and rates of completed Child Adult Medical Procedure Interaction Scale-Short Form (CAMPIS-SF) observations. Secondary clinical outcomes were applied to venipuncture procedures and included CAMPIS-SF coping and distress (range 0-1.0), pain and anxiety on a visual analog scale (range 0-10), and cybersickness symptoms. Results: Overall recruitment was 93\% (66/71), VR withdrawal rate was 27\% (4/15), and of the completed procedures, 100\% (63/63) CAMPIS-SF observations were completed. A total of 55 patients undergoing venipuncture in the pediatric emergency department were included in the analyses of clinical outcomes: 15 patients (15 caregivers) randomized to VR, 20 patients (15 caregivers) randomized to child life specialist support, and 20 patients (17 caregivers) in the reference group. Patient coping differed across groups with higher coping in the VR group and child life specialist group than in the reference group (P=.046). There were no significant differences in the distress and pain ratings for patients and caregivers between the groups. Caregivers rated the lowest perceived anxiety in the child life specialist group (P=.03). There was no apparent change in cybersickness symptoms before and after VR use (P=.37). Conclusions: Real-time documentation of observed behaviors in patients and caregivers was feasible during medical procedures in which VR was utilized, particularly with the availability of research staff. VR and child life specialists improved coping in children during venipuncture procedures. Given the high participation rate, future studies to evaluate the efficacy of VR are recommended to determine whether an off-the-shelf VR headset can be a low-cost and low-risk tool to improve children's coping during venipuncture or other related procedures. Trial Registration: ClinicalTrials.gov NCT03686176; https://clinicaltrials.gov/ct2/show/NCT03686176 ", doi="10.2196/26040", url="https://pediatrics.jmir.org/2021/3/e26040", url="http://www.ncbi.nlm.nih.gov/pubmed/34319249" } @Article{info:doi/10.2196/26328, author="Olbrecht, A. Vanessa and O'Conor, T. Keith and Williams, E. Sara and Boehmer, O. Chloe and Marchant, W. Gilbert and Glynn, M. Susan and Geisler, J. Kristie and Ding, Lili and Yang, Gang and King, D. Christopher", title="Guided Relaxation--Based Virtual Reality for Acute Postoperative Pain and Anxiety in a Pediatric Population: Pilot Observational Study", journal="J Med Internet Res", year="2021", month="Jul", day="12", volume="23", number="7", pages="e26328", keywords="virtual reality", keywords="guided relaxation--based virtual reality", keywords="pain", keywords="anxiety", keywords="acute pain", keywords="postoperative pain", keywords="pediatrics", abstract="Background: Distraction-based therapies, such as virtual reality (VR), have been used to reduce pain during acutely painful procedures. However, distraction alone cannot produce prolonged pain reduction to manage sustained postoperative pain. Therefore, the integration of VR with other pain-reducing therapies, like guided relaxation, may enhance its clinical impact. Objective: The goal of this pilot study was to assess the impact of a single guided relaxation--based VR (VR-GR) session on postoperative pain and anxiety reduction in children. We also explored the influence of pain catastrophizing and anxiety sensitivity on this association. Methods: A total of 51 children and adolescents (7-21 years) with postoperative pain and followed by the Acute Pain Service at Cincinnati Children's Hospital were recruited over an 8-month period to undergo a single VR-GR session. Prior to VR, the patients completed 2 questionnaires: Pain Catastrophizing Scale for Children (PCS-C) and the Child Anxiety Sensitivity Index (CASI). The primary outcome was a change in pain intensity following the VR-GR session (immediately, 15 minutes, and 30 minutes). The secondary outcomes included changes in pain unpleasantness and anxiety. Results: The VR-GR decreased pain intensity immediately (P<.001) and at 30 minutes (P=.04) after the VR session, but not at 15 minutes (P=.16) postsession. Reductions in pain unpleasantness were observed at all time intervals (P<.001 at all intervals). Anxiety was reduced immediately (P=.02) but not at 15 minutes (P=.08) or 30 minutes (P=.30) following VR-GR. Patients with higher CASI scores reported greater reductions in pain intensity (P=.04) and unpleasantness (P=.01) following VR-GR. Pain catastrophizing was not associated with changes in pain and anxiety. Conclusions: A single, short VR-GR session showed transient reductions in pain intensity, pain unpleasantness, and anxiety in children and adolescents with acute postoperative pain. The results call for a future randomized controlled trial to assess the efficacy of VR-GR. Trial Registration: ClinicalTrials.gov NCT04556747; https://clinicaltrials.gov/ct2/show/NCT04556747 ", doi="10.2196/26328", url="https://www.jmir.org/2021/7/e26328", url="http://www.ncbi.nlm.nih.gov/pubmed/34048358" } @Article{info:doi/10.2196/26332, author="Fu, Henry and Garrett, Bernie and Tao, Gordon and Cordingley, Elliott and Ofoghi, Zahra and Taverner, Tarnia and Sun, Crystal and Cheung, Teresa", title="Virtual Reality--Guided Meditation for Chronic Pain in Patients With Cancer: Exploratory Analysis of Electroencephalograph Activity", journal="JMIR Biomed Eng", year="2021", month="Jun", day="24", volume="6", number="2", pages="e26332", keywords="virtual reality", keywords="guided meditation", keywords="neurophysiology", keywords="electroencephalograph", keywords="EEG", abstract="Background: Mindfulness-based stress reduction has demonstrated some efficacy for chronic pain management. More recently, virtual reality (VR)--guided meditation has been used to assist mindfulness-based stress reduction. Although studies have also found electroencephalograph (EEG) changes in the brain during mindfulness meditation practices, such changes have not been demonstrated during VR-guided meditation. Objective: This exploratory study is designed to explore the potential for recording and analyzing EEG during VR experiences in terms of the power of EEG waveforms, topographic mapping, and coherence. We examine how these measures changed during a VR-guided meditation experience in participants with cancer-related chronic pain. Methods: A total of 10 adult patients with chronic cancer pain underwent a VR-guided meditation experience while EEG signals were recorded during the session using a BioSemi ActiveTwo system (64 channels, standard 10-20 configuration). The EEG recording session consisted of an 8-minute resting condition (pre), a 30-minute sequence of 3 VR-guided meditation conditions (med), and a final rest condition (post). Power spectral density (PSD) was compared between each condition using a cluster-based permutation test and across conditions using multivariate analysis of variance. A topographic analysis, including coherence exploration, was performed. In addition, an exploratory repeated measures correlation was used to examine possible associations between pain scores and EEG signal power. Results: The predominant pattern was for increased $\beta$ and $\gamma$ bandwidth power in the meditation condition (P<.025), compared with both the baseline and postexperience conditions. Increased power in the $\delta$ bandwidth was evident, although not statistically significant. The pre versus post comparison also showed changes in the $\theta$ and $\alpha$ bands (P=.02) located around the frontal, central, and parietal cortices. Across conditions, multivariate analysis of variance tests identified 4 clusters with significant (P<.05) PSD differences in the $\delta$, $\theta$, $\beta$, and $\gamma$ bands located around the frontal, central, and parietal cortices. Topographically, 5 peak channels were identified: AF7, FP2, FC1, CP5, and P5, and verified the changes in power in the different brain regions. Coherence changes were observed primarily between the frontal, parietal, and occipital regions in the $\theta$, $\alpha$, and $\gamma$ bands (P<.0025). No significant associations were observed between pain scores and EEG PSD. Conclusions: This study demonstrates the feasibility of EEG recording in exploring neurophysiological changes in brain activity during VR-guided meditation and its effect on pain reduction. These findings suggest that distinct altered neurophysiological brain signals are detectable during VR-guided meditation. However, these changes were not necessarily associated with pain. These exploratory findings may guide further studies to investigate the highlighted regions and EEG bands with respect to VR-guided meditation. Trial Registration: ClinicalTrials.gov NCT00102401; http://clinicaltrials.gov/ct2/show/NCT00102401 ", doi="10.2196/26332", url="https://biomedeng.jmir.org/2021/2/e26332/" } @Article{info:doi/10.2196/25916, author="Logan, E. Deirdre and Simons, E. Laura and Caruso, J. Thomas and Gold, I. Jeffrey and Greenleaf, Walter and Griffin, Anya and King, D. Christopher and Menendez, Maria and Olbrecht, A. Vanessa and Rodriguez, Samuel and Silvia, Megan and Stinson, N. Jennifer and Wang, Ellen and Williams, E. Sara and Wilson, Luke", title="Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management", journal="J Med Internet Res", year="2021", month="Apr", day="26", volume="23", number="4", pages="e25916", keywords="virtual reality", keywords="pediatric", keywords="chronic pain", abstract="Background: Virtual reality (VR) and augmented reality (AR) interventions are emerging as promising tools in the treatment of pediatric chronic pain conditions. However, in this young field, there is little consensus to guide the process of engaging in the development and evaluation of targeted VR-based interventions. Objective: The INOVATE-Pain (Interdisciplinary Network on Virtual and Augmented Technologies for Pain management) consortium aims to advance the field of VR for pediatric chronic pain rehabilitation by providing guidance for best practices in the design, evaluation, and dissemination of VR-based interventions targeting this population. Methods: An interdisciplinary meeting of 16 academics, clinicians, industry partners, and philanthropy partners was held in January 2020. Results: Reviewing the state of the field, the consortium identified important directions for research-driven innovation in VR and AR clinical care, highlighted key opportunities and challenges facing the field, and established a consensus on best methodological practices to adopt in future efforts to advance the research and practice of VR and AR in pediatric pain. The consortium also identified important next steps to undertake to continue to advance the work in this promising new area of digital health pain interventions. Conclusions: To realize the promise of this realm of innovation, key ingredients for success include productive partnerships among industry, academic, and clinical stakeholders; a uniform set of outcome domains and measures for standardized evaluation; and widespread access to the latest opportunities, tools, and resources. The INOVATE-Pain collaborative hopes to promote the creation, rigorous yet efficient evaluation, and dissemination of innovative VR-based interventions to reduce pain and improve quality of life for children. ", doi="10.2196/25916", url="https://www.jmir.org/2021/4/e25916", url="http://www.ncbi.nlm.nih.gov/pubmed/33667177" } @Article{info:doi/10.2196/22620, author="Griffin, Anya and Wilson, Luke and Feinstein, B. Amanda and Bortz, Adeline and Heirich, S. Marissa and Gilkerson, Rachel and Wagner, FM Jenny and Menendez, Maria and Caruso, J. Thomas and Rodriguez, Samuel and Naidu, Srinivas and Golianu, Brenda and Simons, E. Laura", title="Virtual Reality in Pain Rehabilitation for Youth With Chronic Pain: Pilot Feasibility Study", journal="JMIR Rehabil Assist Technol", year="2020", month="Nov", day="23", volume="7", number="2", pages="e22620", keywords="digital health care", keywords="virtual reality", keywords="immersive technology", keywords="chronic pain management", keywords="adolescents", abstract="Background: In the field of pain, virtual reality (VR) technology has been increasingly common in the context of procedural pain management. As an interactive technology tool, VR has the potential to be extended beyond acute pain management to chronic pain rehabilitation with a focus on increasing engagement with painful or avoided movements. Objective: We outline the development and initial implementation of a VR program in pain rehabilitation intervention to enhance function in youth with chronic pain. Methods: We present the development, acceptability, feasibility, and utility of an innovative VR program (Fruity Feet) for pediatric pain rehabilitation to facilitate increased upper and lower extremity engagement. The development team was an interdisciplinary group of pediatric experts, including physical therapists, occupational therapists, pain psychologists, anesthesiologists, pain researchers, and a VR software developer. We used a 4-phase iterative development process that engaged clinicians, parents, and patients via interviews and standardized questionnaires. Results: This study included 17 pediatric patients (13 female, 4 male) enrolled in an intensive interdisciplinary pain treatment (IIPT) program, with mean age of 13.24 (range 7-17) years, completing a total of 63 VR sessions. Overall reports of presence were high (mean 28.98; max 40; SD 4.02), suggestive of a high level of immersion. Among those with multisession data (n=8), reports of pain (P<.001), fear (P=.003), avoidance (P=.004), and functional limitations (P=.01) significantly decreased. Qualitative analysis revealed (1) a positive experience with VR (eg, enjoyed VR, would like to utilize the VR program again, felt VR was a helpful tool); (2) feeling distracted from pain while engaged in VR; (3) greater perceived mobility; and (4) fewer clinician-observed pain behaviors during VR. Movement data support the targeted impact of the Fruity Feet compared to other available VR programs. Conclusions: The iterative development process yielded a highly engaging and feasible VR program based on qualitative feedback, questionnaires, and movement data. We discuss next steps for the refinement, implementation, and assessment of impact of VR on chronic pain rehabilitation. VR holds great promise as a tool to facilitate therapeutic gains in chronic pain rehabilitation in a manner that is highly reinforcing and fun. ", doi="10.2196/22620", url="http://rehab.jmir.org/2020/2/e22620/", url="http://www.ncbi.nlm.nih.gov/pubmed/33226346" } @Article{info:doi/10.2196/23626, author="Rantala, Arja and Jansson, M. Miia and Helve, Otto and Lahdenne, Pekka and Pikkarainen, Minna and P{\"o}lkki, Tarja", title="Parental Experiences of the Pediatric Day Surgery Pathway and the Needs for a Digital Gaming Solution: Qualitative Study", journal="JMIR Med Inform", year="2020", month="Nov", day="13", volume="8", number="11", pages="e23626", keywords="anxiety", keywords="children", keywords="day surgery", keywords="delivery of health care", keywords="digital solution", keywords="gamification", keywords="nursing", keywords="pain", keywords="qualitative study", keywords="technology", abstract="Background: The parents of hospitalized children are often dissatisfied with waiting times, fasting, discharge criteria, postoperative pain relief, and postoperative guidance. Parents' experiences help care providers to provide effective, family-centered care that responds to parents' needs throughout the day surgery pathway. Objective: The objective of our study was to describe parental experiences of the pediatric day surgery pathway and the needs for a digital gaming solution in order to facilitate the digitalization of these pathways. Methods: This was a descriptive qualitative study. The participants (N=31) were parents whose children were admitted to the hospital for the day surgical treatments or magnetic resonance imaging. The data were collected through an unstructured, open-ended questionnaire; an inductive content analysis was conducted to analyze the qualitative data. Reporting of the study findings adheres to the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist. Results: Parental experiences of the children's day surgery pathway included 3 main categories: (1) needs for parental guidance, (2) needs for support, and (3) child involved in his or her own pathway (eg, consideration of an individual child and preparation of child for treatment). The needs for a digital gaming solution were identified as 1 main category---the digital gaming solution for children and families to support care. This main category included 3 upper categories: (1) preparing children and families for the day surgery via the solution, (2) gamification in the solution, and (3) connecting people through the solution. Conclusions: Parents need guidance and support for their children's day surgery care pathways. A digital gaming solution may be a relevant tool to support communication and to provide information on day surgeries. Families are ready for and are open to digital gaming solutions that provide support and guidance and engage children in the day surgery pathways. ", doi="10.2196/23626", url="http://medinform.jmir.org/2020/11/e23626/", url="http://www.ncbi.nlm.nih.gov/pubmed/33185556" } @Article{info:doi/10.2196/17980, author="Smith, Vinayak and Warty, Rikain Ritesh and Sursas, Arun Joel and Payne, Olivia and Nair, Amrish and Krishnan, Sathya and da Silva Costa, Fabricio and Wallace, Morrison Euan and Vollenhoven, Beverley", title="The Effectiveness of Virtual Reality in Managing Acute Pain and Anxiety for Medical Inpatients: Systematic Review", journal="J Med Internet Res", year="2020", month="Nov", day="2", volume="22", number="11", pages="e17980", keywords="virtual reality", keywords="VR", keywords="pain management", keywords="anxiety", keywords="procedural pain", keywords="wound management", keywords="acute pain", keywords="analgesia", keywords="pain", abstract="Background: Virtual reality is increasingly being utilized by clinicians to facilitate analgesia and anxiolysis within an inpatient setting. There is however, a lack of a clinically relevant review to guide its use for this purpose. Objective: To systematically review the current evidence for the efficacy of virtual reality as an analgesic in the management of acute pain and anxiolysis in an inpatient setting. Methods: A comprehensive search was conducted up to and including January 2019 on PubMed, Ovid Medline, EMBASE, and Cochrane Database of Systematic reviews according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Search terms included virtual reality, vr, and pain. Primary articles with a focus on acute pain in the clinical setting were considered for the review. Primary outcome measures included degree of analgesia afforded by virtual reality therapy, degree of anxiolysis afforded by virtual reality therapy, effect of virtual reality on physiological parameters, side effects precipitated by virtual reality, virtual reality content type, and type of equipment utilized. Results: Eighteen studies were deemed eligible for inclusion in this systematic review; 67\% (12/18) of studies demonstrated significant reductions in pain with the utilization of virtual reality; 44\% (8/18) of studies assessed the effects of virtual reality on procedural anxiety, with 50\% (4/8) of these demonstrating significant reductions; 28\% (5/18) of studies screened for side effects with incidence rates of 0.5\% to 8\%; 39\% (7/18) of studies evaluated the effects of virtual reality on autonomic arousal as a biomarker of pain, with 29\% (2/7) demonstrating significant changes; 100\% (18/18) of studies utilized a head mounted display to deliver virtual reality therapy, with 50\% being in active form (participants interacting with the environment) and 50\% being in passive form (participants observing the content only). Conclusions: Available evidence suggests that virtual reality therapy can be applied to facilitate analgesia for acute pain in a variety of inpatient settings. Its effects, however, are likely to vary by patient population and indication. This highlights the need for individualized pilot testing of virtual reality therapy's effects for each specific clinical use case rather than generalizing its use for the broad indication of facilitating analgesia. In addition, virtual reality therapy has the added potential of concurrently providing procedural anxiolysis, thereby improving patient experience and cooperation, while being associated with a low incidence of side effects (nausea, vomiting, eye strain, and dizziness). Furthermore, findings indicated a head mounted display should be utilized to deliver virtual reality therapy in a clinical setting with a slight preference for active over passive virtual reality for analgesia. There, however, appears to be insufficient evidence to substantiate the effect of virtual reality on autonomic arousal, and this should be considered at best to be for investigational uses, at present. ", doi="10.2196/17980", url="https://www.jmir.org/2020/11/e17980", url="http://www.ncbi.nlm.nih.gov/pubmed/33136055" } @Article{info:doi/10.2196/20979, author="Hesam-Shariati, Negin and Newton-John, Toby and Singh, K. Avinash and Tirado Cortes, A. Carlos and Do, Nguyen Tien-Thong and Craig, Ashley and Middleton, W. James and Jensen, P. Mark and Trost, Zina and Lin, Chin-Teng and Gustin, M. Sylvia", title="Evaluation of the Effectiveness of a Novel Brain-Computer Interface Neuromodulative Intervention to Relieve Neuropathic Pain Following Spinal Cord Injury: Protocol for a Single-Case Experimental Design With Multiple Baselines", journal="JMIR Res Protoc", year="2020", month="Sep", day="29", volume="9", number="9", pages="e20979", keywords="EEG neurofeedback", keywords="neuropathic pain", keywords="spinal cord injury", keywords="thalamus", keywords="serious games", keywords="brain-machine interface", keywords="brain-computer interface", keywords="single-case experimental design", abstract="Background: Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury. Spinal cord injury neuropathic pain often is poorly responsive to existing pharmacological and nonpharmacological treatments. A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback. However, further studies are needed to provide more definitive evidence regarding the effectiveness of this intervention. Objective: The primary objective of this study is to evaluate the effectiveness of a multiday course of a brain-computer interface neuromodulative intervention in a gaming environment to provide pain relief for individuals with neuropathic pain following spinal cord injury. Methods: We have developed a novel brain-computer interface-based neuromodulative intervention for spinal cord injury neuropathic pain. Our brain-computer interface neuromodulative treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) power. We will use a single-case experimental design with multiple baselines to examine the effectiveness of our self-developed brain-computer interface neuromodulative intervention for the treatment of spinal cord injury neuropathic pain. We will recruit 3 participants with spinal cord injury neuropathic pain. Each participant will be randomly allocated to a different baseline phase (ie, 7, 10, or 14 days), which will then be followed by 20 sessions of a 30-minute brain-computer interface neuromodulative intervention over a 4-week period. The visual analog scale assessing average pain intensity will serve as the primary outcome measure. We will also assess pain interference as a secondary outcome domain. Generalization measures will assess quality of life, sleep quality, and anxiety and depressive symptoms, as well as resting-state electroencephalography and thalamic $\gamma$-aminobutyric acid concentration. Results: This study was approved by the Human Research Committees of the University of New South Wales in July 2019 and the University of Technology Sydney in January 2020. We plan to begin the trial in October 2020 and expect to publish the results by the end of 2021. Conclusions: This clinical trial using single-case experimental design methodology has been designed to evaluate the effectiveness of a novel brain-computer interface neuromodulative treatment for people with neuropathic pain after spinal cord injury. Single-case experimental designs are considered a viable alternative approach to randomized clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000556943; https://bit.ly/2RY1jRx International Registered Report Identifier (IRRID): PRR1-10.2196/20979 ", doi="10.2196/20979", url="http://www.researchprotocols.org/2020/9/e20979/", url="http://www.ncbi.nlm.nih.gov/pubmed/32990249" } @Article{info:doi/10.2196/17799, author="Hennessy, White Rebecca and Rumble, Deanna and Christian, Mike and Brown, A. David and Trost, Zina", title="A Graded Exposure, Locomotion-Enabled Virtual Reality App During Walking and Reaching for Individuals With Chronic Low Back Pain: Cohort Gaming Design", journal="JMIR Serious Games", year="2020", month="Aug", day="10", volume="8", number="3", pages="e17799", keywords="virtual reality", keywords="chronic low back pain", keywords="walking", keywords="rehabilitation", keywords="virtual reality exposure therapy", abstract="Background: Chronic low back pain (cLBP) can interfere with daily activities, and individuals with elevated pain-related fear (also known as kinesiophobia or the fear of injury due to movement) can develop worse long-term disability. Graded exposure (GEXP) protocols use successive participation in avoided activities to help individuals overcome fearful movement appraisals and encourage activity. We sought to develop a series of GEXP virtual reality (VR) walking and reaching scenarios to increase the exposure and engagement of people with high kinesiophobia and cLBP. Objective: This study aims to (1) determine GEXP content validity of the VR application and (2) determine the feasibility of individuals with cLBP performing locomotion-enabled physical activities. Methods: We recruited 13 individuals with cLBP and high pain-related fear to experience six VR modules, which provide progressive movement exposure over three sessions in a 1 week period. At session 1, participants ranked each module by likelihood to avoid and assigned an expected pain and concern for harming their back rating to each module. Participants provided a rating of perceived exertion (RPE) after experiencing each module. To test feasibility, we administered the system usability scale (SUS) and treatment evaluation inventory (TEI) following the final session. In addition, we measured pain and pain-related fear at baseline and follow-up. Results: The 12 participants who completed the study period assigned higher avoidance (P=.002), expected pain (P=.002), and expected concern (P=.002) for session 3 modules compared with session 1 modules. RPE significantly increased from session 1 (mean 14.8, SD 2.3) to session 3 (mean 16.8, SD 2.2; P=.009). The VR application showed positive feasibility for individuals with cLBP through acceptable SUS (mean 76.7, SD 13.0) and TEI (mean 32.5, SD 4.9) scores. Neither pain (P=.20) nor pain-related fear (P=.58) changed significantly across sessions. Conclusions: The GEXP VR modules provided progressive exposure to physical challenges, and participants found the VR application acceptable and usable as a potential treatment option. Furthermore, the lack of significant change for pain and pain-related fear reflects that participants were able to complete the modules safely. ", doi="10.2196/17799", url="http://games.jmir.org/2020/3/e17799/", url="http://www.ncbi.nlm.nih.gov/pubmed/32773381" } @Article{info:doi/10.2196/19752, author="Ahmadpour, Naseem and Weatherall, David Andrew and Menezes, Minal and Yoo, Soojeong and Hong, Hanyang and Wong, Gail", title="Synthesizing Multiple Stakeholder Perspectives on Using Virtual Reality to Improve the Periprocedural Experience in Children and Adolescents: Survey Study", journal="J Med Internet Res", year="2020", month="Jul", day="17", volume="22", number="7", pages="e19752", keywords="virtual reality", keywords="periprocedural anxiety", keywords="children", keywords="adolescents", keywords="stakeholder perspective", keywords="design", keywords="VR", keywords="pediatrics", keywords="patient experience", keywords="app", keywords="eHealth", abstract="Background: Virtual reality (VR) technology is a powerful tool for augmenting patient experience in pediatric settings. Incorporating the needs and values of stakeholders in the design of VR apps in health care can contribute to better outcomes and meaningful experiences for patients. Objective: We used a multiperspective approach to investigate how VR apps can be designed to improve the periprocedural experiences of children and adolescents, particularly those with severe anxiety. Methods: This study included a focus group (n=4) and a survey (n=56) of clinicians. Semistructured interviews were conducted with children and adolescents in an immunization clinic (n=3) and perioperative setting (n=65) and with parents and carers in an immunization clinic (n=3) and perioperative setting (n=35). Results: Qualitative data were examined to determine the experience and psychological needs and intervention and design strategies that may contribute to better experiences for children in three age groups (4-7, 8-11, and 12-17 years). Quantitative data were used to identify areas of priority for future VR interventions. Conclusions: We propose a set of ten design considerations for the creation of future VR experiences for pediatric patients. Enhancing patient experience may be achieved by combining multiple VR solutions through a holistic approach considering the roles of clinicians and carers and the temporality of the patient's experience. These situations require personalized solutions to fulfill the needs of pediatric patients before and during the medical procedure. In particular, communication should be placed at the center of preprocedure solutions, while emotional goals can be embedded into a procedure-focused VR app to help patients shift their focus in a meaningful way to build skills to manage their anxiety. ", doi="10.2196/19752", url="http://www.jmir.org/2020/7/e19752/", url="http://www.ncbi.nlm.nih.gov/pubmed/32706671" } @Article{info:doi/10.2196/16013, author="Alonso Puig, Mario and Alonso-Prieto, Mercedes and Mir{\'o}, Jordi and Torres-Luna, Raquel and Plaza L{\'o}pez de Sabando, Diego and Reinoso-Barbero, Francisco", title="The Association Between Pain Relief Using Video Games and an Increase in Vagal Tone in Children With Cancer: Analytic Observational Study With a Quasi-Experimental Pre/Posttest Methodology", journal="J Med Internet Res", year="2020", month="Mar", day="30", volume="22", number="3", pages="e16013", keywords="hematology oncology", keywords="pediatric patient", keywords="acute pain", keywords="patient-controlled analgesia", keywords="video pupilometer", keywords="analgesia nociception index", abstract="Background: Patients with secondary pain due to mucositis after chemotherapy require treatment with morphine. Use of electronic video games (EVGs) has been shown to be an effective method of analgesia in other clinical settings. Objective: The main objective of this study was to assess the association between the use of EVGs and the intensity of pain caused by chemotherapy-induced mucositis in pediatric patients with cancer. The secondary objective was to assess the association between changes in pain intensity and sympathetic-parasympathetic balance in this sample of pediatric patients. Methods: Clinical records were compared between the day prior to the use of EVGs and the day after the use of EVGs. The variables were variations in pupil size measured using the AlgiScan video pupilometer (IDMed, Marseille, France), heart rate variability measured using the Analgesia Nociception Index (ANI) monitor (Mdoloris Medical Systems, Loos, France), intensity of pain measured using the Numerical Rating Scale (score 0-10), and self-administered morphine pump parameters. Results: Twenty patients (11 girls and nine boys; mean age 11.5 years, SD 4.5 years; mean weight 41.5 kg, SD 20.7 kg) who met all the inclusion criteria were recruited. EVGs were played for a mean of 2.3 (SD 1.3) hours per day, resulting in statistically significant changes. After playing EVGs, there was significantly lower daily morphine use (before vs after playing EVGs: 35.9 vs 28.6 {\textmu}g/kg/day, P=.003), lower demand for additional pain relief medication (17 vs 9.6 boluses in 24 hours, P=.001), lower scores of incidental pain intensity (7.7 vs 5.4, P=.001), lower scores of resting pain (4.8 vs 3.2, P=.01), and higher basal parasympathetic tone as measured using the ANI monitor (61.8 vs 71.9, P=.009). No variation in pupil size was observed with the use of EVGs. Conclusions: The use of EVGs in pediatric patients with chemotherapy-induced mucositis has a considerable analgesic effect, which is associated physiologically with an increase in parasympathetic vagal tone despite lower consumption of morphine. ", doi="10.2196/16013", url="http://www.jmir.org/2020/3/e16013/", url="http://www.ncbi.nlm.nih.gov/pubmed/32224482" } @Article{info:doi/10.2196/14766, author="Vugts, AP Miel and Zedlitz, MEE Aglaia and Joosen, CW Margot and Vrijhoef, JM Hubertus", title="Serious Gaming During Multidisciplinary Rehabilitation for Patients With Chronic Pain or Fatigue Symptoms: Mixed Methods Design of a Realist Process Evaluation", journal="J Med Internet Res", year="2020", month="Mar", day="9", volume="22", number="3", pages="e14766", keywords="serious gaming", keywords="eHealth", keywords="chronic pain", keywords="medically unexplained symptoms", keywords="implementation", keywords="realist evaluation", abstract="Background: Serious gaming could support patients in learning to cope with chronic pain or functional somatic syndromes and reduce symptom burdens. Objective: To realize this potential, insight is needed into how, why, for whom, and when it works in actual treatment circumstances. Methods: Following a realist approach, process evaluations were performed before, during, and after a two-armed, natural quasi-experiment (n=275). A group of patients with interfering chronic pain or fatigue symptoms received a short additional blended mindfulness-based serious gaming intervention during a multidisciplinary rehabilitation program. A control group only received the regular rehabilitation program. During two sessions before and one session after the experiment, expectations about serious gaming processes were discussed in focus groups with local care providers, implementers, and experts. Patients participated in a survey (n=114) and in semistructured interviews (n=10). The qualitative data were used to develop tentative expectations about aspects of serious gaming that, in certain patients and circumstances, trigger mechanisms of learning and health outcome change. Hypotheses about indicative quantitative data patterns for tentative expectations were formulated before inspecting, describing, and analyzing---with regression models---routinely collected clinical outcome data. An updated program theory was formulated after mixing the qualitative and quantitative results. Results: Qualitative data showed that a subset of patients perceived improvement of their self-awareness in moments of daily social interactions. These results were explained by patients, who played the serious game LAKA, as a ``confrontation with yourself,'' which reflected self-discrepancies. Important characteristics of serious gaming in the study's context included innovation factors of relative advantage with experiential learning opportunity, compatibility with the treatment approach, and the limited flexibility in regard to patient preferences. Perceived patient factors included age and style of coping with stress or pain. Learning perceptions could also depend on care provider role-taking and the planning and facilitating (ie, local organization) of serious gaming introduction and feedback sessions in small groups of patients. Quantitative data showed very small average differences between the study groups in self-reported depression, pain, and fatigue changes (-.07