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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

Aged 6 to 17 years

Required to undergo any dental procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up heart rate will be measured immediately before the procedure and for the entire duration of the procedure (approximately 30-60 minutes)

Awards & highlights

Study Summary

This trial is testing whether using virtual reality (VR) can help reduce fear and anxiety in children during dental procedures. The researchers want to compare the effectiveness of VR to watching a cartoon on a TV screen

Who is the study for?

This trial is for children who experience dental fear and anxiety when facing dental procedures. To join, they must have a condition related to oral health or have suffered a traumatic dental injury. Children with certain medical conditions that could interfere with the study or those who cannot use VR due to other reasons are not eligible.Check my eligibility

What is being tested?

The trial is testing if using Virtual Reality (VR) games during dental visits can help reduce fear and anxiety in children more effectively than watching cartoons on TV. Kids will wear an eye-tracking VR headset that doesn't require head movement, making it easier for dentists to work.See study design

What are the potential side effects?

While there may not be direct side effects from the interventions being tested, some participants might experience discomfort or dizziness from wearing a VR headset. The study aims to ensure these devices do not impede dental treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 17 years old.

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I need to have a dental procedure done.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ satisfaction questionnaire is reported by healthcare professional immediately following completion of the dental procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~satisfaction questionnaire is reported by healthcare professional immediately following completion of the dental procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and satisfaction questionnaire is reported by healthcare professional immediately following completion of the dental procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety

Secondary outcome measures

Healthcare professional's satisfaction

Heart rate in beats per minute

Intervention completion

+5 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor

196 Previous Clinical Trials

78,941 Total Patients Enrolled

Sylvie Le May, PhDPrincipal InvestigatorSt. Justine's Hospital

13 Previous Clinical Trials

1,413 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current total number of participants being recruited for this clinical study?

"Indeed, the details available on clinicaltrials.gov indicate that this study is actively seeking eligible participants. The initial posting date for this trial was November 1st, 2023, and it underwent its last update on December 12th, 2023. This particular study aims to enroll a total of 88 participants at a single designated location."

Answered by AI

Are new participants currently being accepted for enrollment in this ongoing medical study?

"Indeed, as per the information provided by clinicaltrials.gov, this clinical trial is currently in the recruitment phase. The initial posting of the trial occurred on November 1st, 2023 and it was last updated on December 12th, 2023."

Answered by AI

Are individuals aged 40 and above eligible to participate in the patient recruitment for this clinical trial?

"To participate in this clinical trial, individuals must meet the age requirements of being between 6 and 17 years old."

Answered by AI

Which individuals are eligible to partake in this experimental study?

"To be eligible for this research study, individuals must experience dental anxiety and fall within the age range of 6 to 17 years old. The trial is planning to enroll approximately 88 participants who meet these criteria."

Answered by AI

Recent research and studies

International Journal of Environmental Research and Public HealthJournal

Blocked Randomization with Randomly Selected Block Sizes

Efird, Jimmy. 2010. “Blocked Randomization with Randomly Selected Block Sizes”. International Journal of Environmental Research and Public Health. MDPI AG. doi:10.3390/ijerph8010015.

The Journal of PainJournal

Core Outcome Domains and Measures for Pediatric Acute and Chronic/recurrent Pain Clinical Trials: Pedimmpact Recommendations

McGrath, Patrick J., Gary A. Walco, Dennis C. Turk, Robert H. Dworkin, Mark T. Brown, Karina Davidson, Christopher Eccleston, et al.. 2008. “Core Outcome Domains and Measures for Pediatric Acute and Chronic/recurrent Pain Clinical Trials: Pedimmpact Recommendations”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2008.04.007.

clinicaltrials.govStudy

Virtual Reality Distraction for Dental Anxiety (RCT)

Sylvie Le May 2023. "Virtual Reality Distraction for Dental Anxiety (RCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06182462.