RecruitingNot ApplicableNCT06182462

Virtual Reality Distraction for Dental Anxiety (RCT)

The Effects of A Virtual Reality Game on Anxiety During Dental Procedures in Children (VR-TOOTH): A Randomized, Controlled Trial Protocol

Sponsor

St. Justine's Hospital

Enrollment

88 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Dental Diseases Dental Anxiety Dental Phobia Dental Trauma

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).

Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a virtual reality (VR) headset during dental procedures reduces anxiety and pain in children. Dental anxiety is very common in kids and can lead to avoidance of care throughout life. This trial examines whether VR distraction is an effective, non-medication way to make dental visits more comfortable. **You may be eligible if...** - Your child is between 6 and 17 years old - Your child's dentist has recommended they participate - Your child needs to have any dental procedure done - A parent or legal guardian who can read French or English will be present **You may NOT be eligible if...** - Your child has epilepsy - Your child has paralysis or weakness in the hands needed to use the VR device - Your child has a diagnosed eye disease or problem - Your child has another condition that would prevent safe VR use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEVirtual 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.

DEVICEDental 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.