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Virtual Reality for Children's Anxiety During MRI

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

Accompanied by a consenting parent or legal guardian who can understand, read and write either French or English

Aged from 7 to 17 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline (t0), immediately after the vr intervention at 15 minutes (t1), and measured after the mri at 45 minutes (t2)

Awards & highlights

Study Summary

This trial will study the effect of virtual reality games on reducing anxiety in children scheduled for an MRI. It will also use biofeedback to identify which children are more responsive to the intervention.

Who is the study for?

This trial is for children aged 7 to 17 who need an MRI and have a parent or guardian who can consent in French or English. It's not suitable for those outside this age range or without parental consent.Check my eligibility

What is being tested?

The study tests if playing a VR game before an MRI can help manage anxiety compared to standard care. Participants will be randomly placed into two groups: one with the VR game prep and one with usual care, to see which works better.See study design

What are the potential side effects?

While not explicitly mentioned, potential side effects may include dizziness, nausea, or discomfort from wearing the VR headset. The biofeedback device might also cause minor skin irritation.

Eligibility Criteria

Inclusion Criteria

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

Select...

My parent or guardian who speaks English or French has agreed to help me with this trial.

Select...

I am between 7 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (t0) at 15 minutes (t1) and at 45 minutes (t2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (t0) at 15 minutes (t1) and at 45 minutes (t2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (t0) at 15 minutes (t1) and at 45 minutes (t2) 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

Level of state-trait anxiety in children

Secondary outcome measures

Children's satisfaction

Head deviation in space

Healthcare professional's satisfaction

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Reality DistractionExperimental Treatment1 Intervention

Use of Virtual Reality (VR) before the MRI.

Group II: Standard TreatmentActive Control1 Intervention

Standard Treatment used at the radiology department.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual reality

2020

N/A

~1890

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Maisonneuve-Rosemont HospitalOTHER

99 Previous Clinical Trials

36,225 Total Patients Enrolled

St. Justine's HospitalLead Sponsor

196 Previous Clinical Trials

78,931 Total Patients Enrolled

2 Trials studying Pediatrics

1,562 Patients Enrolled for Pediatrics

Sylvie Le May, PhDPrincipal InvestigatorResearch Centre CHU Sainte-Justine

13 Previous Clinical Trials

1,403 Total Patients Enrolled

1 Trials studying Pediatrics

98 Patients Enrolled for Pediatrics

Media Library

Virtual Reality Clinical Trial Eligibility Overview. Trial Name: NCT04988516 — N/A

Pediatrics Research Study Groups: Virtual Reality Distraction, Standard Treatment

Pediatrics Clinical Trial 2023: Virtual Reality Highlights & Side Effects. Trial Name: NCT04988516 — N/A

Virtual Reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT04988516 — N/A

Frequently Asked Questions

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

Under what criteria can individuals gain access to this clinical research study?

"Individuals between the age of 7 and 17 with a diagnosis of anxiety can sign up for this clinical trial. Up to 98 participants are needed in order to meet its recruitment goals."

Answered by AI

Are enrollment opportunities for participants still available in this research?

"Correct. According to clinicaltrials.gov, this medical research initiative is currently searching for applicants, with the initial posting being made on May 27th 2022 and last amended on April 30th 2023. This study requires 98 participants from one site."

Answered by AI

What are the expected results of this research project?

"This trial will primarily evaluate the efficacy of an intervention on participant anxiety, as measured by Change from Baseline (T0) at 15 minutes (T1) and 30 minutes (T2). Additionally, the studywill also assess secondary objectives such as Head deviation in space, Heart Rate, and Oxygen Saturation. The head position during simulation is quantified with cameras, accelerometers and gyroscopes embedded within a headset; while heart rate and oxygen saturation levels are captured through wearable biofeedback devices."

Answered by AI

How many participants are included in this research project?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial, first posted on May 27th 2022 and most recently edited April 30th 2023, is actively recruiting patients from one medical centre with the goal of enrolling 98 participants."

Answered by AI

Are geriatric individuals sought after for this clinical research?

"The qualifications for participation in this study necessitate that all applicants are between the ages of 7 and 17. A total of 195 studies have been conducted on children younger than 18, while 525 clinical trials focus on adults over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality Distraction for Anxiety (VR-IMAGINE)

Sylvie Le May 2022. "Virtual Reality Distraction for Anxiety (VR-IMAGINE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04988516.

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