Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 5, 2025
Date Accepted: May 12, 2026
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Pilot Feasibility Clinical Trial of Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures: Study Protocol for a Randomized Clinical Trial
ABSTRACT
Background:
Lasers have wide applications in medicine and dermatology, but are associated with pain and anxiety, particularly in younger patients. Pain mitigation is often limited to topical anesthetics in the outpatient setting. Distraction techniques are limited by the need for ocular protection, which can include adhesive eye patches that can completely occlude vision. Virtual reality is effective at managing procedural pain and anxiety under other short medical procedures and is a promising tool for this population.
Objective:
This trial aims to assess the safety, feasibility, and efficacy of Virtual Reality Pain Alleviation Therapeutic (VR-PAT) for pain management during outpatient laser procedures.
Methods:
40 patients requiring outpatient laser therapy for at least two sessions will be recruited from a pediatric hospital in the Midwest for this crossover randomized, two-arm clinical trial with a 1:1 allocation ratio. During the first laser visit, the participant will be randomly assigned to either play the VR-PAT game during their procedure or wear the headset with a dark screen. Participants will answer questions about their pain, anxiety, and pain medication usage. Those playing the VR-PAT will additionally report simulator sickness symptoms and their experience playing the game. At their second laser visit, participants will crossover to the opposite intervention from the one they received at their first visit. The primary outcomes are the difference in self-reported pain and anxiety between the two interventions.
Results:
The study began enrollment in January 2023. To date, 44 participants have finished their first visit. Final results are planned for February 2026, after all data have been collected and analyzed.
Conclusions:
Virtual reality is a promising digital technology that can improve the experience of patients requiring dermatologic laser therapy. Findings from this innovative randomized clinical trial will provide early evidence on the efficacy of the VR-PAT for reducing self-reported pain and anxiety during outpatient laser procedures. The results from this trial will inform a large-scale, multisite study. Clinical Trial: ClinicalTrials.gov: NCT05645224 [https://clinicaltrials.gov/study/NCT05645224]
Citation
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Copyright
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