Introduction. Dental fear and anxiety (DFA) is a condition that affects approximately a quarter of children and adolescents. Lack of patient cooperation due to DFA can create an environment of stress, often obligating dentists to end appointments prematurely. Virtual reality use could improve DFA in children with special health care needs (SHCN) undergoing dental procedures. Aim. Assess the feasibility and acceptability of VR immersion as a tool to reduce dental fear and anxiety in pediatric special needs patients undergoing dental procedures and gain insight on parents and healthcare providers perspectives on the use of VR during dental appointments. Methods. This pilot randomized controlled trial study will follow a parallel design including two groups: A control group (clinic's standard care) and an experimental group (virtual reality). Twenty participants will be randomized to either group. Recruitment will be carried out at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary-quaternary care center that mostly serves pediatric patients with SHCN. The experimental group will receive the VR video game Dream designed specifically for this study. It aims at reducing anxiety in children aged 6 to 17 years old by mean of immersive distraction. The VR headset offers children with the ability of viewing the game they are playing in real time while simultaneously obstructing the partial view they would normally have of the procedure. The primary outcome will be assessment of dental fear and anxiety in children using both observation-based proxy assessment with the Venham Anxiety and Behavior Rating Scale (VABRS) and a physiological biomarker such as the level of salivary alpha-amylase. Sociodemographic characteristics, measures of level of satisfaction of parents and healthcare professionals, occurrence of side effects and any deviation from normal procedure length will also be collected. Analysis will be carried out using statistical analysis software SAS (version 9.4; Cary, NC, USA). Descriptive statistics will be conducted for demographic and clinical variables and will be used to present parents and healthcare professionals' satisfaction levels, and also procedural time. Discussion. The investigators believe that the results of this pilot study will provide a better understanding of the feasibility and effect of VR on DFA in children with SHCN.
Age range
6 Years – 17 Years
Sex
ALL
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The patient recruitment rates and of completion rate of planned procedures
Timeframe: Patient requirement rates and completion rate of planned procedures will be reported throughout study completion (approx 1 year)
Parent's or legal guardian's satisfaction
Timeframe: Satisfaction questionnaire is reported by parents immediately following completion of the dental procedure
Anxiety
Timeframe: Anxiety scale score is recorded by the operator at the following timepoints: Before the dental procedure to establish baseline; immediately after of completion of dental intervention appointment
Healthcare professional's satisfaction
Timeframe: Satisfaction questionnaire is reported by healthcare professional immediately following completion of the dental procedure
Change in Salivary Alpha-Amylase Concentrations before and after dental procedure
Timeframe: Salivary amylase swab will be performed at the following timepoints: Baseline pre-dental procedure; immediately after completion of dental intervention appointment