Virtual Reality Distraction for Dental Anxiety (RCT)
Canada88 participantsStarted 2023-11-01
Plain-language 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).
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 6 to 17 years;
. Received the dentist's recommendation to participate;
. Required to undergo any dental procedure;
. Accompanied by a parent or a legal guardian who can understand, read, and write in either French or English.
Exclusion criteria
. Suffer from epilepsy,
. Paralysis or paresis of the hand
. Has any diagnosed eye disease/problem,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anxiety
Timeframe: Anxiety scale score is recorded by the operator at the following timepoints: Before the dental procedure to establish baseline; immediately after the completion of dental intervention appointment