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Behavioural Intervention
Virtual Reality Distraction for Dental Anxiety
N/A
Recruiting
Led By Sylvie Le May, PhD
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patient requirement rates and completion rate of planned procedures will be reported throughout study completion (approx 1 year)
Awards & highlights
Study Summary
This trial studies using virtual reality to reduce dental fear and anxiety in children with special health care needs undergoing dental procedures.
Who is the study for?
This trial is for children aged 6 to 17 with special health care needs who experience dental fear and anxiety. They must be recommended by a dentist, need a dental procedure, and have a parent or guardian who understands French or English. Kids with epilepsy or conditions that prevent VR use cannot participate.Check my eligibility
What is being tested?
The study tests if virtual reality can help reduce dental anxiety in kids during appointments compared to standard treatment at the clinic. It involves two groups: one experiencing VR distraction and the other receiving usual care, with outcomes measured by behavior scales and saliva tests.See study design
What are the potential side effects?
There may be side effects related to using virtual reality such as dizziness, nausea, or eye strain. However, children prone to seizures or similar conditions are not included in this study due to potential risks associated with VR.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patient requirement rates and completion rate of planned procedures will be reported throughout study completion (approx 1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient requirement rates and completion rate of planned procedures will be reported throughout study completion (approx 1 year)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Change in Salivary Alpha-Amylase Concentrations before and after dental procedure
Healthcare professional's satisfaction
+2 moreSecondary outcome measures
Length of procedure
Number of rescheduled of procedures
Occurrence of side effects
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Reality DistractionExperimental Treatment1 Intervention
Use of virtual reality (VR) during dental procedure.
Group II: Standard TreatmentActive Control1 Intervention
Dental Clinic's standard treatment during dental procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Reality Distraction
2016
Completed Phase 3
~740
Find a Location
Who is running the clinical trial?
St. Justine's HospitalLead Sponsor
196 Previous Clinical Trials
79,009 Total Patients Enrolled
Sylvie Le May, PhDPrincipal InvestigatorSt. Justine's Hospital
13 Previous Clinical Trials
1,481 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My parent or guardian can understand and write in English or French.I do not have epilepsy or conditions that prevent me from using VR.I need to have a dental procedure done.I am between 6 and 17 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Reality Distraction
- Group 2: Standard Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research study accessible to individuals of senior age?
"The age range for prospective participants in this clinical trial is 6 to 17 years old."
Answered by AI
What is the enrollment capacity for this research project?
"Correct. Information on clinicaltrials.gov indicates that this medical trial is searching for participants, and was first posted June 6th 2023 with the latest update being July 12th 2023. The study requires enrollment of around two dozen patients from one site."
Answered by AI
Does the vetting process enable me to participate in this experiment?
"This experiment is searching for 20 individuals aged between 6 and 17 years of age who experience dental fear. In addition, candidates must satisfy the following prerequisites: Be referred by a dentist, Require any sort of oral procedure, Possess an adult guardian capable of understanding French or English both verbally and literately."
Answered by AI
Are there any openings in this study for prospective participants?
"Affirmative. Details on clinicaltrials.gov imply that this study, which was initially announced on June 6th 2023, is still actively searching for participants. A total of twenty individuals will be accepted from one medical site."
Answered by AI
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