Skip to main content
Clinical Trials/NCT06380283
NCT06380283
Recruiting
Not Applicable

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

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country128 target enrollmentMarch 21, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Children, Only
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
128
Locations
1
Primary Endpoint
Children's pain perception during dental treatment
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 21, 2024
End Date
January 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Beatriz Ferraz dos Santos

Pediatric dentist; research director

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

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)

Outcomes

Primary Outcomes

Children's pain perception during dental treatment

Time Frame: 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

Time Frame: Baseline

The Child Fear Scale will be used to assess the anxiety felt by the participants during dental treatment

Secondary Outcomes

  • Oral health care provider's acceptability of virtual reality during dental care(Baseline)
  • Children's acceptability of virtual reality intervention during dental care(Baseline)

Study Sites (1)

Loading locations...

Similar Trials