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Virtual Reality for 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 change from baseline (t0) at 15 minutes (t1) and at 45 minutes (t2)
Awards & highlights
No Placebo-Only Group
Summary
This trial will examine the use of immersive virtual reality (IVR) to reduce anxiety in children during MRIs. Results will guide medical practice & provide evidence on non-pharmacological anxiety management.
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 designed to see if playing a virtual reality game before the scan helps with anxiety.
What is being tested?
The study tests whether a pre-procedural immersive VR game can reduce anxiety during MRIs compared to standard care. Participants will be randomly assigned to either the VR group or usual care, with equal numbers in each group.
What are the potential side effects?
Potential side effects may include discomfort from wearing the VR headset, dizziness, nausea, or eye strain due to exposure to virtual reality. The study will monitor these effects through questionnaires.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline (t0), immediately after the vr intervention has ended at 15 minutes (t1), and measured after the mri at 45 minutes (t2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline (t0), immediately after the vr intervention has ended at 15 minutes (t1), and measured after the mri 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
Level of anxiety
Level of state-trait anxiety
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
2017
Completed Phase 3
~1580
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Who is running the clinical trial?
St. Justine's HospitalLead Sponsor
200 Previous Clinical Trials
86,045 Total Patients Enrolled
10 Trials studying Anxiety
682 Patients Enrolled for Anxiety
Sylvie Le May, PhDPrincipal InvestigatorSt. Justine's Hospital
13 Previous Clinical Trials
1,403 Total Patients Enrolled
6 Trials studying Anxiety
422 Patients Enrolled for Anxiety
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My parent or guardian who speaks English or French will accompany me and can consent.I cannot play virtual reality games due to epilepsy or another condition.I can sit in a semi-upright position for the VR session.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.