Recruiting

Virtual Reality

Sponsor:

St. Justine's Hospital

Code:

NCT06182462

Conditions

Dental Anxiety

Dental Phobia

Dental Trauma

Dental Diseases

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Accepted

Interventions

Virtual Reality Distraction

Dental Clinic's Standard Treatment

Study Details

Brief 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

Study ID

NCT06182462

Start date

Nov 1, 2023

Status verified date

Aug, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Aged 6 to 17 years;
2. Received the dentist's recommendation to participate;
3. Required to undergo any dental procedure;
4. Accompanied by a parent or a legal guardian who can understand, read, and write in either French or English.

Exclusion Criteria:

1. Suffer from epilepsy,
2. Paralysis or paresis of the hand
3. Has any diagnosed eye disease/problem,
4. Any other conditions preventing them from using virtual reality (VR) (e.g., epidermolysis bullosa).

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Reality Distraction

Use of virtual reality (VR) during dental procedure.

active comparator: Standard Treatment

Dental Clinic's standard treatment during dental procedure.

Interventions

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.

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.

Primary outcome measure

  • Anxiety [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Sylvie Le May, PhD

5143454931sylvie.lemay@umontreal.ca

Locations

St.Justine's Hospital

Recruiting

Montreal, Quebec, Canada, H1T 3C5

Contacts

Sylvie Le May, PhD

5143454931sylvie.lemay@umontreal.ca

Principal Investigator:

Sylvie Le May, PhD

More Information

Sponsor

St. Justine's Hospital

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2025-08-24.