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Behavioural Intervention

Pediatric dental treatment using VR for Dental Anxiety

N/A

Recruiting

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children aged between 6 and 12 years and their accompanying parent/legal-guardian

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trial aims to see if using a Virtual Reality headset can help reduce pain and anxiety in children during dental procedures. The study will involve two groups: one receiving standard care and the other using the VR

Who is the study for?

This trial is for children who experience dental anxiety during procedures. To participate, they must be undergoing a dental treatment and willing to use a VR headset or follow standard care. There are no specific exclusion criteria provided.Check my eligibility

What is being tested?

The study tests if using Virtual Reality headsets can help manage kids' anxiety during dental visits compared to the usual behavior management techniques. It's a randomized trial where participants are split into two groups: one with VR distraction and one without.See study design

What are the potential side effects?

Since this trial involves non-invasive technology, side effects may include discomfort from wearing the VR headset or motion sickness but generally should have minimal risks associated with its use.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a child aged 6-12, or I am their parent/legal guardian.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Children's fear during dental treatment

Children's pain perception during dental treatment

Secondary outcome measures

Children's acceptability of virtual reality intervention during dental care

Oral health care provider's acceptability of virtual reality during dental care

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pediatric dental treatment using VRExperimental Treatment1 Intervention

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.

Group II: Control groupActive Control1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual reality headset

2017

N/A

~150

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

449 Previous Clinical Trials

159,718 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available positions for participants in this research study?

"Indeed, the details on clinicaltrials.gov indicate that this particular trial is currently in search of eligible participants. The initial posting date for this clinical trial was March 21st, 2024, and the most recent modification was made on April 18th, 2024. A total of 128 individuals are being sought at a single designated location."

Answered by AI

Could those who are younger than 55 years of age participate in this current medical study?

"Eligible candidates for this research endeavor are children aged 6 to 12 years. Notably, there is a total of 192 investigations focused on individuals below 18 years and 305 studies targeting those above 65 years old."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"Yes, information from clinicaltrials.gov indicates that this trial is currently seeking participants. The study was initially listed on March 21st, 2024 and the most recent update was on April 18th, 2024. The research aims to recruit a total of 128 individuals at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Beatriz Ferraz dos Santos 2024. "The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06380283.