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.

چکیده اصلی

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 and analgesic consumption and incidence of chronic postoperative pain. Analyses will be based on an intention-to-treat approach, employing a linear mixed model to compare the effect of VR to CAU over time. Additional analyses will evaluate usability, user satisfaction, cost-effectiveness and predictors of treatment response. ETHICS AND DISSEMINATION: The Erasmus MC Medical Ethics Review Committee, Rotterdam, the Netherlands granted ethical approval for this study in July 2025. Results from this study will be published as soon as possible after completed data collection in international peer-reviewed scientific journals. CLINICAL TRIAL REGISTRATION: NL-OMON57871.

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