Feasibility and acceptability of perioperative application of biofeedback-based virtual reality versus active control for pain and anxiety in children and adolescents undergoing surgery: Protocol for a pilot randomised controlled trial

Introduction Current clinical applications of virtual reality (VR) provide patients with transient pain relief during acutely painful events by redirecting attention. Biofeedback (BF) is a mind-body therapy that effectively produces sustained pain reduction, but there are obstacles to its routine use. Combined, BF-based VR (VR-BF) may increase accessibility while enhancing the benefits of BF. VR-BF has yet to be employed in perioperative care, and as such, no defined treatment protocol for VR-BF exists. The primary aim of this study is to assess the feasibility of the perioperative use of VR-BF in children and adolescents. The secondary aims are to assess the acceptability of VR-BF and to collect pilot efficacy data. Methods and analysis This is a single-centre, randomised controlled pilot clinical trial. A total of 70 patients (12-18 years) scheduled for surgery anticipated to cause moderate to severe pain with ≥1 night of hospital admission will be randomised to one of two study arms (VR-BF or control). Participants randomised to VR-BF (n=35) will use the ForeVR VR platform to engage their breathing in gamified VR applications. Participants randomised to control (n=35) will interact with a pain reflection app, Manage My Pain. The primary outcome is feasibility of VR-BF use in adolescents undergoing surgery as assessed through recruitment, enrolment, retention and adherence to the protocol. Secondary outcomes are acceptability of VR-BF and pilot efficacy measures, including pain, anxiety and opioid consumption. Ethics and dissemination The protocol was approved by the Nationwide Children's Hospital Institutional Review Board (IRB #STUDY00002080). Patient recruitment begins in March 2023. Written informed consent is obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals. Data will be available per request and results will be posted on ClinicalTrials.gov. Trial registration number ClinicalTrials.gov Registry (NCT04943874).