JMIR Publications

ABSTRACT

Background:

Dental fear and anxiety affect approximately a quarter of children and adolescents. It significantly contributes to pediatric patients avoiding dental care later in adulthood. Lack of cooperation due to dental fear and anxiety can create a stressful environment, often forcing dentists to end appointments prematurely and consider alternative pharmacological treatments. The use of virtual reality during dental procedures, offering an immersive sensory experience, may serve as an additional non-pharmacologic tool to better manage dental fear and anxiety in children with special healthcare needs undergoing dental treatment.

Objective:

This study aims to assess the effectiveness of virtual reality immersion in reducing anxiety and pain among pediatric patients with special needs undergoing dental procedures. The study also seeks to understand the satisfaction of parents and healthcare providers with the use of virtual reality 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 virtual reality. 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 centre that primarily serves pediatric patients with special healthcare needs. The two primary outcomes will include both observed and objective biomarker-based measures of anxiety. Dental fear and anxiety will be evaluated using the Venham Anxiety Rating Scale as well as changes in mean levels of Salivary Alpha-Amylase. Sociodemographic characteristics, parents’ and healthcare professionals’ satisfaction levels, participants’ pain intensity and behaviour 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 healthcare professionals' satisfaction levels, child satisfaction with the game, and procedural time.

Results:

This study will be conducted from November 2023 to December 2025, with results expected to be available in June 2026.

Conclusions:

We believe that the results of this study will confirm the efficacy of virtual reality in reducing dental fear and anxiety in children with special healthcare needs, providing an additional non-pharmacological alternative for better managing this condition in pediatric hospital settings. Clinical Trial: Clinicaltrials.gov NCT06182462 (https://clinicaltrials.gov/study/NCT06182462?term=NCT06182462&rank=1)