Immersive virtual reality vs. non-immersive distraction for pain management of children during bone pins and sutures removal: A randomized clinical trial protocol.

Aims To examine the efficacy of an immersive virtual reality distraction compared with an active non-immersive distraction, such as video games on a tablet, for pain and anxiety management and memory of pain and anxiety in children requiring percutaneous bone pins and/or suture removal procedures. Design Three-centre randomized clinical trial using a parallel design with two groups: experimental and control. Methods Study to take place in the orthopaedic department of three children hospital of the Montreal region starting in 2019. Children, from 7-17 years old, requiring bone pins and/or suture removal procedures will be recruited. The intervention group (N = 94) will receive a virtual reality game (Dreamland), whereas the control group (N = 94) will receive a tablet with video games. The primary outcomes will be both the mean self-reported pain score measured by the Numerical Rating Scale and mean anxiety score, measured by the Child Fear Scale. Recalls of pain and anxiety will be measured 1 week after the procedure using the same scales. We aim to recruit 188 children to achieve a power of 80% with a significance level (alpha) of 5%. Discussion While multiple pharmacological methods have previously been tested for children, no studies have evaluated the impact of immersive virtual reality distraction for pain and anxiety management in the orthopaedic setting. Impact Improved pain management can be achieved using virtual reality during medical procedures for children. This method is innovative, non-pharmacological, adapted to the hospital setting, and user-friendly. Trial Registration NCT03680625, registered on clinicaltrials.gov.