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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06380283
Enrollment
128
Registered
2024-04-23
Start date
2024-03-21
Completion date
2026-01-31
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Children, Only, Dental Anxiety

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.

Interventions

DEVICEVirtual reality headset

Use of a virtual reality headset during pediatric dental care

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Children's pain perception during dental treatmentBaselineChildren'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 treatmentBaselineThe Child Fear Scale will be used to assess the anxiety felt by the participants during dental treatment

Secondary

MeasureTime frameDescription
Children's acceptability of virtual reality intervention during dental careBaselineThe Patient Perception 5-item questionnaire will be used to assess participants acceptability of the VR intervention.
Oral health care provider's acceptability of virtual reality during dental careBaselineA 4-point Likert-scale questionnaire will be used to assess oral health care providers' acceptability of VR during dental treatment.

Countries

Canada

Contacts

Primary ContactBeatriz Ferraz dos Santos, DDS, MSc
beatriz.ferrazdossantos@muhc.mcgill.ca+1 (514) 412-4400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026