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

Not Applicable

Recruiting

• Conditions: Children, Only; Dental Anxiety; Behavior
• Interventions: Device: Virtual reality headset

• Registration Number: NCT06380283
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2024-03-21
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-07
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pediatric dental treatment using VR	Virtual reality headset	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.

Primary Outcome Measures

Name	Time	Method
Children's pain perception during dental treatment	Baseline	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.
Children's fear during dental treatment	Baseline	The Child Fear Scale will be used to assess the anxiety felt by the participants during dental treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada