Abstract
BACKGROUND: The hospital experience is often marked by fear and pain, particularly for children undergoing medical procedures. Sedation is commonly used to alleviate patient anxiety, but it poses additional health risks. Caregivers, usually the parents, also experience emotional distress during the child's hospital stay, which can further exacerbate the child's anxiety and pain. While various interventions exist to ease patient distress, few consider the emotional well-being of caregivers. OBJECTIVE: This study aims to explore the effectiveness of a cooperative virtual reality (VR) game as a novel nonpharmacological solution to reduce anxiety and pain for both pediatric patients and their caregivers during medical procedures. Specifically, we aim to investigate whether the VR game "Sweet Dive VR" (SDVR), designed for children aged between 6 and 12 years to play with 1 caregiver, can alleviate anxiety and pain during different types of needle punctures and Kirschner-wire removal. METHODS: A prospective multicenter randomized clinical trial will be conducted. Eligible participants will be identified by scanning the hospital information system, and group allocation will follow stratified randomization. During the medical procedure, patients in the VR condition will play SDVR with a caregiver present, while patients in the control group will listen to a recording of gently crashing waves. Data collection will be carried out through self-reports of patients and caregivers using visual analog scales and questionnaires at 2 measurement time points: before and after the intervention. In addition, observation by the interviewers will occur during the intervention to capture emotional and pain reactions as well as interaction quality between patients and caregivers and smoothness of the procedure flow using a structured observation protocol. The measured variables will encompass patient affect and pain, caregiver affect, player experience, patient experience, and the flow of the procedure. RESULTS: As of November 2024, we enrolled 39 patients and caregivers, 28 of whom completed the study. Data collection is still ongoing. CONCLUSIONS: Cooperative VR gaming, as exemplified by SDVR, emerges as a promising intervention to address anxiety and pain in pediatric patients while involving caregivers to support the emotional well-being of both parties. Our approach strives to foster positive shared experiences and to maintain trust between children and caregivers during emotionally challenging medical situations. TRIAL REGISTRATION: German Clinical Trial Register (DRKS) DRKS00033544; https://drks.de/search/en/trial/DRKS00033544. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63098.