Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures: Protocol for a Pilot Randomized Clinical Trial.

Background: Lasers have wide applications in medicine 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 eye patches that completely occlude vision. Virtual reality (VR) is effective at managing procedural pain and anxiety during other short medical procedures and is a promising tool for this population. Objective: This trial aims to assess the safety, feasibility, and efficacy of the virtual reality pain alleviation therapeutic (VR-PAT) for pain management during outpatient laser procedures. Methods: A total of 40 patients requiring outpatient laser therapy for at least 2 sessions will be recruited from a pediatric hospital in the Midwestern United States for this crossover randomized, 2-arm clinical trial. During the first laser visit, the participants 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 (Numeric Rating Scale 0-10), anxiety (State-Trait Anxiety Inventory for Children, Numeric Rating Scale 0-10, and Modified Yale Preoperative Anxiety Scale), and pain medication usage. Those playing the VR-PAT will report simulator sickness symptoms and their experience playing the game. At their second laser visit, participants will cross over to the opposite intervention. The primary outcomes are the differences in self-reported pain and anxiety between the 2 interventions. Feasibility outcomes include the proportion of screened patients who were eligible, have given consent, and completed both visits, as well as adverse events reported. To evaluate the efficacy of pain reduction, composite pain scores, and pain medication usage will be calculated for each laser visit. To evaluate the efficacy of anxiety reduction, the change in Modified Yale Preoperative Anxiety Scale scores will be compared between control and VR groups at each visit using the Wilcoxon rank sum tests. All statistical analyses will follow the intention-to-treat principle with regard to intervention assignment at each visit. Results: The study was funded in January 2023 and began enrollment at that time. A total of 44 participants were recruited, and data collection was completed in November 2025, with 40 participants completing both visits. The sample was balanced, with 40 participants using the intervention and participating in the control condition. The age range of the complete sample was 6 to 21 years at recruitment, and 22 (55%) were female. Data analysis is in progress with final results planned for June 2026. Conclusions: Findings from this innovative randomized clinical trial will provide early evidence on the efficacy of the VR-PAT in reducing self-reported pain and anxiety during outpatient laser procedures. The results from this trial will inform a large-scale, multisite study.