Virtual Reality Distraction for Dental Anxiety (RCT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorSt. Justine's Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Distraction
DeviceThe 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
DeviceThe 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.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality DistractionExperimental treatment 1 intervention
Group B: Standard TreatmentActive comparator 1 intervention
Trial outcomes
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.
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 appointmentSecondary outcomes
1
Parent's or legal guardian satisfaction
Parent's or legal guardian's satisfaction on the intervention and side effects will be assessed using the Visual analog Scale, (0-10, where 0 is very dissatisfied and 10 in very satisfied) and following the recommended question by Pediatric Initiatives on Methods, Measurement and Pain Assessment in Clinical Trials (PedIMMPACT): "Considering anxiety relief, side effects and emotional recovery, how satisfied were you with the intervention used to manage anxiety experienced by your child?"
Time frame
Satisfaction questionnaire is reported by parents immediately following completion of the dental procedure2
Healthcare professional's satisfaction
Healthcare professional's satisfaction on the intervention will be assessed using the Visual Analog Scale, (VAS; ranked from 0-10, where 0 is very dissatisfied and 10 in very satisfied) as well as a 6-question satisfaction questionnaire (each answer will be given a score of 1,2,3,or 4 based on the choice of response (respectively: Totally disagree, Disagree, Agree, Totally agree) and will result in a final score between 6 and 24.
Time frame
Satisfaction questionnaire is reported by healthcare professional immediately following completion of the dental procedure3
Heart rate in beats per minute
Heart rate will be continuously measured using COVIDIEN Nellcor psaturation meter, an approved and validated device.
Time frame
Heart rate will be measured immediately before the procedure and for the entire duration of the procedure (Approximately 30-60 minutes)4
Oxygen saturation
Oxygen saturation will be continuously measured using COVIDIEN Nellcor pulse oxygen saturation meter, an approved and validated device.
Time frame
Oxygen saturation will be measured immediately before the procedure and for the entire duration of the prodedure (Approximately 30-60 minutes)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov