Smartphone virtual reality for pain management during pediatric burn care transition: study protocol for a randomized controlled trial.

BACKGROUND

Burn injuries severe enough to result in emergency department visits are a large burden for US children. Treatment for these injuries often involves daily dressing changes at home, which can be very painful and anxiety-inducing. This trial aims to evaluate the efficacy of a virtual reality therapeutic for pain and anxiety alleviation during repeated at-home burn dressing changes among pediatric patients.

METHODS

Two hundred children with burn injuries requiring daily dressing changes will be recruited from two American Burn Association-verified burn centers in the USA for this randomized, controlled, two-arm clinical trial with a 1:1 allocation ratio. During each dressing change at home, the intervention group will play the Virtual Reality Pain Alleviation Therapeutic (VR-PAT) game and answer questions about their pain, anxiety state, pain medication usage, simulator sickness symptoms, and experience playing the game. The control group will perform their dressing as usual without the VR-PAT and answer questions about their pain, anxiety state, and pain medication usage. The primary outcome is the difference in self-reported pain and anxiety between the two groups over their week of dressing changes.

DISCUSSION

The transition of burn injury treatment from the medical center to the home can increase anxiety for children and their parents. Virtual reality is a promising digital technology that can improve wound care for these children. Findings from this trial will provide data on the efficacy of the VR-PAT for reducing self-reported pain and anxiety during daily home dressing changes for pediatric burn care. The results from this trial will serve as evidence for a large-scale implementation study.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05673551. Registered on December 21, 2022.