Virtual Reality Distraction for Dental Anxiety (RCT)

Summary

The aim of this randomized clinical trial is to verify the efficacy of VR immersion over a muted cartoon on a wall-mounted TV to decrease dental fear and anxiety of children undergoing dental procedures. The study also aims to gain insight on the satisfaction of parents and healthcare providers on the use of VR during dental appointments.

Main research question: Does VR immersion compare to a cartoon on a wall-mounted TV is more efficacious to decrease dental fear and anxiety of children requiring dental procedures?

Participants will be playing through a VR immersive game wearing a eye-tracking VR headset that requires no movement of the head to play, facilitating the dental procedure.

The investigators will take measures of the stress levels of participants and their parents using a validated stress scale and also by taking salivary samples to verify the levels of a stress biomarker (alpha-amylase).

Conditions

• Dental Anxiety
• Dental Phobia
• Dental Trauma
• Dental Diseases

Interventions

DEVICE

Virtual Reality Distraction

The experimental group will receive a VR video game called "DREAM DENTAL" designed specifically for this study. Pharmaceutical treatment during the procedure such as the use of injected local anesthesia will be used if the procedure requires. Children will be able to play for the entire duration of the dental procedure. The VR video game aims at reducing anxiety in children aged 6 to 17 years old by means 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. In the event of non-cooperation during the appointment, any retake or re-scheduling appointments will be compiled by the research assistant or resident dentist. One parent will be allowed in the room during the dental procedure and their presence will be recorded.

DEVICE

Dental Clinic's Standard Treatment

The control group will only receive a care-as-usual approach. This includes viewing cartoons on a muted mounted television set and the use of pharmaceutical treatment during the procedure such as the use of injected local anesthesia, according to the procedure. In the event of non-cooperation during the appointment, any retake or re-scheduling appointments will be compiled by the research assistant. One parent will be permitted to be present in the room during the procedure as part of the clinic's usual protocol and their presence will be recorded. Children allocated to the control group will be offered the possibility to try the VR game after the study period if they choose to do so.

Sponsors & Collaborators

• St. Justine's Hospital

  lead OTHER

Principal Investigators

• Sylvie Le May, PhD · St. Justine's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-01

Primary Completion

2025-11-30

Completion

2026-03-31

Countries

• Canada

Study Locations