Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomized, controlled trial (FOREVR Peds trial)

ABSTRACT Introduction Virtual reality (VR) offers an innovative method to deliver nonpharmacological pain management. Distraction-based VR (VR-D) using immersive games to redirect attention has shown short-term pain reductions in various settings. To create lasting pain reduction, VR-based strategies must go beyond distraction. Guided relaxation-based VR (VR-GR) integrates pain-relieving mind-body based guided relaxation with VR, a novel therapy delivery mechanism. The primary aim of this study is to assess the impact of daily VR-GR, VR-D, and 360 video (passive control) on pain intensity and opioid consumption. We will also assess the impact of these interventions on pain unpleasantness, anxiety, and benzodiazepine consumption. The secondary aim of this study will assess the impact of psychological factors (anxiety sensitivity, pain catastrophizing) on pain following VR. Methods and analysis This is a single center, prospective, randomized, clinical trial. Ninety children/adolescents, ages 8 to 18 years, presenting for Nuss repair of pectus excavatum will be randomized to 1 of 3 study arms (VR-GR, VR-D, 360 video). Patients will use the Starlight Xperience (Google Daydream) VR suite for 10-minutes. Patients randomized to VR-GR (n=30) will engage in guided relaxation/mindfulness with the Aurora application. Patients randomized to VR-D (n=30) will play 1 of 3 distraction-based games, and those randomized to the 360 video (n=30) will watch the Aurora application without audio instructions or sound. Primary outcomes are pain intensity and opioid consumption. Secondary outcomes include pain unpleasantness, anxiety, and benzodiazepine consumption. Ethics and dissemination This study follows SPIRIT guidelines. The protocol was approved by the Cincinnati Children’s Hospital Medical Center Institutional Review Board. The trial has not yet begun recruiting (recruitment to begin July 2020). Written informed consent will be obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals. Trial registration number ClinicalTrials.gov NCT04351776 , registered April 3, 2020. ARTICLE SUMMARY Strengths and limitations of this study - This is a prospective, randomized clinical trial, which provides the best clinical evidence and support for VR as an intervention. - This is the first study examining the use of VR-based interventions in a postoperative pediatric population. - Due to the nature of the study, it cannot be blinded. - One limitation is the specific patient population being studied: children and adolescents between the ages of 8 and 18 years undergoing Nuss repair of pectus excavatum. Patient selection may limit generalizability of findings. - A second limitation is the conduction of the study at an academic, tertiary care, pediatric hospital; as such, these results may not be generalizable to patients in other clinical settings.