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

Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06380283
• Other study ID #: 2024-10221
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2024
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Beatriz Ferraz dos Santos, DDS, MSc
• Phone: +1 (514) 412-4400
• Email: beatriz.ferrazdossantos[@]muhc.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: January 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Behavior
• Children, Only
• Dental Anxiety

Intervention

Device:
• Virtual reality headset
Use of a virtual reality headset during pediatric dental care

Locations

Country	Name	City	State
Canada	Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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