Efficacy of A Virtual Reality Game on Children’s Fear and Anxiety During Dental Procedures (VR-TOOTH): A Randomized, Controlled Trial Protocol (Preprint)

<sec> <title>BACKGROUND</title> Dental fear and anxiety (DFA) is a condition that affects approximately a quarter of children and adolescents. It is a significant cause for pediatric patients to avoid dental care later in adulthood. Lack of patient cooperation due to DFA can create an environment of stress, often obligating dentists to end appointments prematurely and consider alternative pharmacological treatment options. Virtual reality use during dental care, providing an immersive experience through sensory stimuli, is potentially an additional non-pharmacologic tool to better manage DFA in children with special healthcare needs (SHCN) undergoing dental procedures. </sec> <sec> <title>OBJECTIVE</title> This study aims to measure the efficacy of VR immersion as a tool to reduce anxiety and pain in pediatric special needs patients undergoing dental procedures. The study also aims to gain insight into the satisfaction of parents and healthcare providers with the use of VR during dental appointments. </sec> <sec> <title>METHODS</title> This randomized controlled trial study will follow a parallel design including two groups: a control group (clinic’s standard care) and an experimental group (VR). 404 participants (including an attrition rate of 10%) will be randomized equally to either group. Recruitment will be carried out at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary-quaternary care centre that mostly serves pediatric patients with SHCN. The two primary outcomes will capture both observed and objective biomarker-based measures of anxiety. DFA will be evaluated using the anxiety subscale of the Venham Anxiety and Behavioural Scales (VABS) (22) as well as changes in mean levels of Salivary Alpha-Amylase (SAA) before (T0) and during the intervention (T1). Sociodemographic characteristics, measures of parental and healthcare professional satisfaction levels, pain intensity, behaviour during the procedure, changes in heart rate, occurrence of side effects, duration of the procedure, and any deviations from normal procedural length will also be collected. Descriptive and comparative statistics will be conducted for demographic and comparisons on clinical variables and will be used to present sociodemographic and clinical data, parents' and healthcare professionals' satisfaction levels, child satisfaction with the game and procedural time. </sec> <sec> <title>RESULTS</title> This study will be conducted from November 2023 to October 2025, with results expected to be available in June 2026. </sec> <sec> <title>CONCLUSIONS</title> We believe that the results of this study will confirm the efficacy of VR on DFA in children with SHCN and will provide an additional non-pharmacological alternative to better manage DFA in the pediatric population in the hospital setting. </sec> <sec> <title>CLINICALTRIAL</title> NCT06182462 https://clinicaltrials.gov/study/NCT06182462?cond=dental&amp;aggFilters=ages:child,status:not%20rec&amp;rank=1 </sec>