Effects of Virtual Reality on PostOperative WEllbeing and recovery (POWER of VR) in children and adolescents undergoing major surgery: study protocol for a prospective, multicentre randomised controlled trial
Abstract
Introduction: Postoperative pain in children and adolescents is frequently reported, despite numerous advancements in pain management strategies. Virtual reality (VR) is a non-pharmacological tool, which has shown to be effective in reducing acute and procedural pain in children and adolescents. However, there are no studies on VR as an adjunctive treatment of postoperative pain management in the paediatric population. The aim of this study is to evaluate the effectiveness of VR in reducing postoperative pain in children and adolescents undergoing major surgery.
Methods and analysis: This is a multicentre, prospective, unblinded randomised controlled trial conducted in two tertiary academic children's hospitals in the Netherlands. 159 children and adolescents aged 6-18 undergoing major surgery with expected moderate to severe postoperative pain will be included. Patients will be stratified according to pain treatment and subsequently randomised into two study arms with a 2:1 allocation ratio to receive either (a) VR intervention plus care as usual (CAU) or (b) CAU alone during the first 3 days postoperatively. The primary outcome of this study is the difference between the two intervention groups in rate of change in postoperative pain scores during the first 3 days postoperatively, measured by the Numeric Rating Scale Pain. Secondary outcomes include the immediate- and long-term effects of VR on pain intensity, anxiety, trauma-related symptoms, quality of recovery, opioid…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 159 participants or records.
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