Virtual Reality Distraction for Dental Anxiety (RCT)

NCT06182462 | Recruiting DMC

• 1 other identifier: VR-TOOTH - RCT
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Anxiety

  To evaluate and observe preliminary effects of VR distraction, we will be using the Venham Anxiety and Behavioural Scale (VABRS). It is an observation-based assessment by proxy for dental fear and anxiety and are among the most frequent behavior scoring models for DFA. It is composed of two scales used to assess the anxiety and uncooperative behavior of children in the dental setting. Both scales consist of a 6-point scale, with 6 defined behavioral levels that range from 0 to 5. The highest score defines the highest anxiety level or lack of cooperation.

  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

Secondary Outcomes (8)

• Parent's or legal guardian satisfaction

  Satisfaction questionnaire is reported by parents immediately following completion of the dental procedure

• Healthcare professional's satisfaction

  Satisfaction questionnaire is reported by healthcare professional immediately following completion of the dental procedure

• Heart rate in beats per minute

  Heart rate will be measured immediately before the procedure and for the entire duration of the procedure (Approximately 30-60 minutes)

• Oxygen saturation

  Oxygen saturation will be measured immediately before the procedure and for the entire duration of the prodedure (Approximately 30-60 minutes)

• Salivary alpha-amylase

  Salivary Alpha-Amylase will be measured immediately before and 10-minutes after the procedure

Study Arms (2)

Virtual Reality Distraction

EXPERIMENTAL

Use of virtual reality (VR) during dental procedure.

Device: Virtual Reality Distraction

Standard Treatment

ACTIVE COMPARATOR

Dental Clinic's standard treatment during dental procedure.

Device: Dental Clinic's Standard Treatment

Interventions

Virtual Reality Distraction DEVICE

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.

Virtual Reality Distraction

Dental Clinic's Standard Treatment DEVICE

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.

Standard Treatment

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

St.Justine's Hospital

Montreal, Quebec, H1T 3C5, Canada

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• Sylvie Le May, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Le May, PhD

CONTACT

5143454931; sylvie.lemay@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: December 27, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: March 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)