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

NCT ID: NCT06380283

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-21
• Study Completion Date: 2026-01-31

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.

Conditions

Children, Only; Dental Anxiety; Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual reality headset

Intervention Type: DEVICE

Use of a virtual reality headset during pediatric dental care

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality headset

Use of a virtual reality headset during pediatric dental care

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Beatriz Ferraz dos Santos

Pediatric dentist; research director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Beatriz Ferraz dos Santos, DDS, MSc

Role: CONTACT

beatriz.ferrazdossantos@muhc.mcgill.ca

+1 (514) 412-4400 ext. 23357

Facility Contacts

Beatriz Ferraz dos Santos, DDS, MSc

Role: primary

beatriz.ferrazdossantos@muhc.mcgill.ca

+1 (514) 412-4400 ext. 23357

Other Identifiers

2024-10221

Identifier Type: -

Identifier Source: org_study_id