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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06380283
Other study ID # 2024-10221
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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