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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric dental treatment using VR | Experimental | 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. |
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| Control group | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality headset | Device | Use of a virtual reality headset during pediatric dental care |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Oral health care provider's acceptability of virtual reality during dental care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Ferraz dos Santos, DDS, MSc | Contact | +1 (514) 412-4400 | 23357 | beatriz.ferrazdossantos@muhc.mcgill.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre | Recruiting | Montreal | Quebec | Canada |
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A 4-point Likert-scale questionnaire will be used to assess oral health care providers' acceptability of VR during dental treatment. |
| Baseline |
| ID | Term |
|---|---|
| D001519 | Behavior |
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