Efficacy of a Virtual Reality Game on Children's Fear and Anxiety During Dental Procedures (VR-TOOTH): Protocol for a Randomized Controlled Trial.

Background: Dental fear and anxiety (DFA) affects approximately a quarter of children and adolescents. It significantly contributes to pediatric patients avoiding dental care later in adulthood. Lack of cooperation due to DFA can create a stressful environment, often forcing dentists to end appointments prematurely and consider alternative pharmacological treatments. The use of virtual reality (VR) during dental procedures, offering an immersive sensory experience, may serve as an additional nonpharmacologic tool to better manage DFA in children with special health care needs (SHCN) undergoing dental treatment. Objective: This study aims to assess the effectiveness of VR immersion in reducing anxiety and pain among pediatric patients with SHCN undergoing dental procedures. The study also seeks to understand the satisfaction of parents and health care providers with the use of VR during dental appointments. Methods: This randomized controlled trial follows a parallel design with two groups: a control group receiving standard care and an experimental group using VR. A sample size of 400 participants was calculated. Participants will be randomly assigned equally to each group. Recruitment will take place at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary- and quaternary-care center that primarily serves pediatric patients with SHCN. The two primary outcomes will include both observed and objective biomarker-based measures of anxiety. DFA will be evaluated using the Venham Anxiety Rating Scale as well as changes in mean levels of salivary alpha-amylase. Sociodemographic characteristics, parents' and health care professionals' satisfaction levels, participants' pain intensity and behavior during the procedure, changes in heart rate, occurrence of side effects, procedure duration, and any deviations from normal procedural length will also be collected. Descriptive and comparative statistics will be conducted for demographic and clinical comparisons and will be used to present sociodemographic and clinical data, parents' and health care professionals' satisfaction levels, child satisfaction with the game, and procedural time. Results: This study will be conducted from November 2023 to December 2025. As of November 2025, 300 participants have been recruited. Results are expected to be available in June 2026. Conclusions: We believe that the results of this study will confirm the efficacy of VR in reducing DFA in children with SHCN, providing an additional nonpharmacological alternative for better managing this condition in pediatric hospital settings.