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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
Must not have
Have a diagnosis of epilepsy or any other condition preventing them from playing a virtual reality game
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
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot play virtual reality games due to epilepsy or another condition.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anxiety
Level of state-trait anxiety in children
Secondary study objectives
Children's satisfaction
Head deviation in space
Healthcare professional's satisfaction
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1850
Find a Location
Who is running the clinical trial?
Maisonneuve-Rosemont HospitalOTHER
101 Previous Clinical Trials
38,229 Total Patients Enrolled
St. Justine's HospitalLead Sponsor
200 Previous Clinical Trials
85,742 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can sit in a semi-upright position as required for VR gear.My parent or guardian who speaks English or French has agreed to help me with this trial.I cannot play virtual reality games due to epilepsy or another condition.I am between 7 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.
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