In this single-center randomized controlled trial, patients attending for IUD insertion in the outpatient gynecology clinic were screened for eligibility. Patients were eligible if aged 18 years and older and able to provide written informed consent. Patients were excluded if they had contraindications to IUD insertion, a history of epilepsy or vestibular disorders contraindicating VR use, an inability to consent, or if they had taken prescription pain relief prior to the procedure (simple analgesia was permitted).

Patients were randomized on the day of IUD insertion in the outpatient clinic to either the intervention group (addition of VR to standard care) or the control group (standard care). A computerized random sequence was generated, with allocations then placed in sequentially numbered opaque envelopes by a blinded third party. These envelopes were opened only after participants were enrolled in the study by the researcher, who was not otherwise involved in the patient’s care. Participants were not paid for their participation. Given the obvious nature of VR as an intervention and the subjective nature of pain and anxiety as outcomes, blinding was not possible.

VR digital content was delivered via smartphone and headset during the IUD insertion procedure. The content provided a relaxing, noninteractive 3D video of seals swimming with gentle classical music (Figure 1). The visual content was chosen by the investigators to ensure its suitability for the patient population and minimize any patient reactions to objectionable content. Content containing dialogue was considered inappropriate as it would interfere with clinical communication during this intimate procedure. Standard care included occasional use of a lignocaine spray to the cervix according to the clinician’s preference, and this was therefore recorded as part of the data collection.

Several pain scales exist and can be used to quantify the pain intensity from IUD insertion, including the Visual Analog Scale (VAS), the Verbal Rating Scale, and the Numerical Rating Scale [20]. The VAS is reliable, valid, and sensitive to subtle differences and changes in pain intensity [20]. For this reason, it is the most consistently used tool [21] and has been used in prior studies of discomfort associated with IUD insertion [3,5]. VAS differences of 10 mm are considered clinically significant from previous studies [22,23].

Patient demographic information was collected by reviewing the patient’s medical records and full consultation notes. In addition, patients were asked to plot their anxiety prior to the procedure, and their pain and anxiety during the procedure on a linear 10-cm VAS. Numerical VAS scores were then obtained by measuring the distance along the line to the nearest millimeter. Patients also completed a questionnaire on their satisfaction, recommendations, and side effects after the procedure. The time required for IUD insertion, clinician-reported ease of insertion on a scale of 1 to 5, and number of attempts required for successful IUD insertion (defined as the number of attempts to pass the IUD through the cervix) were also reported (Multimedia Appendix 1).

Statistical analyses were conducted in SPSS 25 (IBM Corp). Significance was defined as P <.05. Two-tailed t-tests were performed for group-wide comparisons.

For our power calculation, we assumed an equal SD of 14 mm in VAS pain scores between groups based on previous studies of VAS pain scores in women with pelvic pain during IUD insertion [24]. To achieve 80% of detecting a 10-mm difference between groups with a type 1 error rate of 0.05, we required a sample size of 31 in each group. Accounting for a compliance rate of 90%, we aimed for a sample size of 70 participants.

The study was approved by Monash Health Ethics Committee, Clayton, Victoria, Australia (ethics approval reference number 80700 and Monash Health reference number RES-21-0000-690A). The trial was prospectively registered (Australia and New Zealand Clinical Trial Registry ACTRN12622000088741p). Written informed consent was obtained from all participants following counseling, with time allowed for patients to review the participant information and consent form. Patients were able to opt out of the study at any stage if they chose to withdraw consent to participate. There were no payments or incentives or compensation provided that could result in pressure to participate. Data collected were deidentified and stored on secure password-protected servers, with all data converted to electronic copies and hard copies destroyed in confidential waste to protect patient privacy.

Despite the many benefits of IUDs, patient discomfort is a significant barrier to accessing outpatient insertion [2,4]. There is little evidence and no clear consensus on the best methods of addressing this discomfort without this being performed under general anesthesia, which itself presents costs and risks [12].

This study found no significant difference in anxiety or pain with VR headset use and identified anxiety as the most significant predictor of pain.

Interestingly, despite pain and anxiety scores not significantly differing between the 2 groups, the VR headsets may have benefits that may still be relevant for procedural acceptability. The VR intervention was effective and well-received in a subpopulation of responders, particularly those with reduced levels of pre-existing anxiety. Satisfaction and recommendation for the VR headsets were overall very high, demonstrating patient appreciation of these devices. Patients were provided with the opportunity to comment on their experience, and those who did were overwhelmingly positive. The reasons for high satisfaction and recommendation for VR use appear to be related predominantly to the distraction effect.

Patients’ comments particularly highlighted that they appreciated the distraction provided by the headsets, with 1 patient reporting the distraction was helpful for anxiety, while others stated the distraction helped them to forget about the procedure. Other possible reasons for the positive patient feedback for the VR devices may include the novelty of the equipment or other psychological benefits, which, although difficult to quantify, may improve the acceptability of outpatient IUD insertion with VR use despite the lack of improvement in pain scores.

As VR grows in its implementation in the health care space, several studies have recently been published on its use in outpatient gynecological procedures. The existing body of evidence relating directly to IUD insertion is scant and contradictory, with the study by Benazzouz et al directly contradicting findings from Oz et al [16,17]. Both studies were randomized trials, recruiting patients in a contraceptive clinic on the day of IUD insertion, applying VR headsets, and collecting similar data measures, including the use of the VAS for pain rating; however, the studies had important methodological differences.

The study by Benazzouz et al [16] was conducted in France in 100 patients with a mean age of roughly 24 years and found no difference in pain or anxiety with VR headset use, but preprocedure anxiety was identified as a significant predictor of pain. Postprocedure mean pain scores in this study were around 5, similar to our study. Most patients underwent copper IUD insertion, which is known to be less painful, and approximately 80% of patients took preprocedural analgesia that included opiates and other prescription medications, factors which may have biased results toward the null.

The study by Oz et al [17] was conducted in Turkey and recruited 80 patients with a mean age of around 24 years. They used copper IUDs and found a reduction in postprocedural pain and anxiety scores with the use of VR. Mean pain scores were around 2 cm. This study’s strengths included its uniform use of only 1 VR visual and audio immersion option for all participants, similar to our study. However, the description of inclusion criteria was limited, and confounders such as previous cervical instrumentation, chronic pain, or other concurrent analgesia use were not stated.

Our study is the first to evaluate the use of VR for IUD insertion in an Australian setting. It has multiple similarities to the study by Benazzouz et al [16], including similar mean pain scores and no benefit for pain or anxiety with VR device use. Its prospective design and randomization are strengths and add to the sparse body of literature. We enrolled a representative sample of individuals who would be seen for IUDs in an Australian tertiary hospital context. The IUDs used in our study were predominantly levonorgestrel devices, in contradistinction to the other studies. Other strengths include practical, real-life, broad inclusion criteria, and we excluded people who had taken pain relief other than simple analgesia.

This study has limitations. First, although our study was practically oriented and therefore purposefully limited in the data instruments collected, this limited our ability to more deeply understand which subpopulations might benefit from this intervention or not. Deeper characterization of responder and nonresponder populations, particularly with regard to anxiety, would be an important consideration for future studies.

Second, this was a single-center study with multiple operators, so results may not apply to other operators or populations; however, the outcomes observed are plausible and concordant with other data. It is also possible that factors inherent to our study population may have limited the efficacy of VR headset use.

Third, although randomization is supposed to produce confounder balance, there were apparent differences between groups in our study. The VR group was more likely to have IUDs inserted for abnormal uterine bleeding and a history of chronic pain and less likely to have undergone previous cervical instrumentation. These factors could contribute to the patients’ interactions with pain experiences and expectations prior to IUD insertion, which in turn can worsen pain. These confounders may have blunted the measured effect in this study. It is also possible that other potential unmeasured confounders may have impacted the outcome (eg, unmeasured history of substance use).

In addition, despite a formal power calculation, we cannot exclude the possibility that this study was underpowered, given that we observed a much higher SD in pain scores than we had anticipated. Pain is an inherently subjective phenomenon, and individual variability in the reporting of these outcomes can be vexing. If future studies are to be performed, these could be on a larger scale in a multicenter context to explore a broader patient population and improve the generalizability of results while reducing the likely impact of possible confounders.

Another possible limiting factor could be that the type of content provided to patients, though thought to be appropriate, may not have been optimal. By standardizing the content provided, we provided a repeatable intervention, but this may have come at the cost of patient preferences for content and interests, and therefore immersion. There may also have been factors unique to the IUD procedure and our busy clinical environment that may have inhibited the formation of a therapeutic alliance.

Finally, due to the nature of this VR intervention, blinding of both clinicians and patients was not feasible.

Future studies should be directed toward helping to improve the patient experience with IUD insertion. In addition to larger population studies to maximize generalizability of results and ability for subgroup analysis, there are several more specific areas identified by this study that warrant future consideration:

First, further qualitative studies regarding the other possible benefits of VR use for IUD insertion should be considered, given the positive response from patients regarding this despite the lack of improvement in pain and anxiety scores.

Second, the finding that preprocedural anxiety was most predictive of pain raises the question of whether providing anxiety management prior to IUD insertion could be beneficial. It may be that using VR prior to the procedure could be a useful way to reduce anxiety, potentially reduce pain, and ultimately improve procedural tolerability.

Finally, further research is required into optimizing VR content to maximize its interactivity and immersion, particularly in the gynecological context. Co-design with patients should be considered, and a balance will need to be reached between depth of VR immersion while also maintaining adequate situational awareness such that the patient can continue to provide consent to the intimate examinations being undertaken. This particularly requires cautious curation of the audio content to allow clinician communication with the patient. Visual imagery also needs to keep in mind the sensitive nature of this procedure type and therefore should avoid imagery that could be misconstrued or considered triggering for patients with a history of sexual trauma. This is a unique challenge that was felt to limit the appropriate options of VR content in this study and needs to be explored in depth in future VR research. Tailoring content for subgroup-specific features, such as heightened anxiety, or clinical characteristics, such as sexual trauma, may result in greater benefit.

Importantly, this study found that the most significant predictor of pain was patient anxiety, consistent with Bennazouz et al [16] and the broader VR literature. This also predicted the patients who would benefit from VR use with reduced pain scores. This implies that efforts should be focused on managing patient anxiety prior to IUD insertion as a method of alleviating patient pain, and there may be a role for VR in the anxiety-reducing preprocedural setting that should be explored further in future research. The high satisfaction and recommendation for VR during IUD insertion in this trial also highlight that there may be other benefits to VR which have not yet been measured. This may indicate that VR could be considered as a supplemental tool rather than a primary method for pain relief. Ultimately, the goal to facilitate timely, more tolerable outpatient IUD insertions remains a clinical and research priority.