Behavior Clinical Trial
Official title:
The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety
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 |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Canada | Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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