Recruiting

Virtual Reality

Sponsor:

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

Code:

NCT06380283

Conditions

Children, Only

Dental Anxiety

Behavior

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Interventions

Virtual reality headset

Study Details

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 ID

NCT06380283

Start date

Mar 21, 2024

Status verified date

Dec, 2023

Completion date

Jan, 2026

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

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

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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).

Interventions

Virtual reality headset

Use of a virtual reality headset during pediatric dental care

Primary outcome measure

  • Children's pain perception during dental treatment [ Time Frame: Baseline ]
  • Children's fear during dental treatment [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Beatriz Ferraz dos Santos, DDS, MSc

+1 (514) 412-4400beatriz.ferrazdossantos@muhc.mcgill.ca

Locations

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

Recruiting

Montreal, Quebec, Canada

Contacts

Beatriz Ferraz dos Santos, DDS, MSc

+1 (514) 412-4400beatriz.ferrazdossantos@muhc.mcgill.ca

More Information

Sponsor

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

Last update posted

Apr 23, 2024

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-04-23.