The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety

The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.

This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment.

Study Overview

• Status: Recruiting
• Conditions: Dental Anxiety; Behavior; Children, Only
• Intervention / Treatment: Device: Virtual reality headset

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beatriz Ferraz dos Santos, DDS, MSc; Phone Number: 23357 +1 (514) 412-4400; Email: beatriz.ferrazdossantos@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Recruiting
      • Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre
      • Contact: Beatriz Ferraz dos Santos, DDS, MSc; Phone Number: 23357 +1 (514) 412-4400; Email: beatriz.ferrazdossantos@muhc.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged between 6 and 12 years and their accompanying parent/legal-guardian.
• Children scheduled for one of the following procedures: restorative treatments (amalgam, composite or stainless-steel crowns), pulp therapy and extractions
• Children that can understand and speak French or English.

Exclusion Criteria:

• Children diagnosed with a cognitive, auditory, or cognitive impairment preventing them from interacting with the VR game.
• Children diagnosed with epilepsy or any other condition preventing them from playing the VR game.
• Children requiring urgent dental care
• Children requiring dental treatment with conscious sedation (i.e. nitrous oxide inhalation and/or oral sedation with benzodiazepines)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pediatric dental treatment using VR; At the beginning of the dental visit, subjects enrolled in the virtual reality (VR) group (n=64) will receive instructions about how to operate the VR system. The research team will then properly fit VR headset onto the child's head and ensure that there are no discomforts. Then, the research team will monitor the intervention using the tablet interface, allowing them to start, pause, and stop the VR intervention. The child will be given 5 minutes to get used to the device. During this time, any adjustments to the headset will be made. The VR intervention will last the duration of the dental procedure, unless told otherwise by the patient, their parent/legal-guardian, or the research team. The entire VR intervention will be closely monitored for any adverse events. Time of play and the patients' compliance of using VR will be noted.	Device: Virtual reality headset; Use of a virtual reality headset during pediatric dental care
No Intervention: Control group; Subjects enrolled in the control group (n=64) will receive their dental care using the behavior management techniques recommended by the American Academy of Pediatric Dentistry (i.e., tell-show-so, communicative guidance, distraction through stories and positive reinforcement).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's pain perception during dental treatment	Children's perception of pain during dental treatment will be assessed by the Wong- Baker FACES scale. The 'Face, Legs, Activity, Cry, Consolability' (FLACC), a common behavioral pain external observation scale, will also be used. Higher the score more discomfort and pain experienced by the patient.	Baseline
Children's fear during dental treatment	The Child Fear Scale will be used to assess the anxiety felt by the participants during dental treatment	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's acceptability of virtual reality intervention during dental care	The Patient Perception 5-item questionnaire will be used to assess participants acceptability of the VR intervention.	Baseline
Oral health care provider's acceptability of virtual reality during dental care	A 4-point Likert-scale questionnaire will be used to assess oral health care providers' acceptability of VR during dental treatment.	Baseline

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2024-10221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No