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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

Study 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.Check my eligibility

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.See study design

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline (t0), immediately after the vr intervention has ended at 15 minutes (t1), and measured after the mri 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

Level of anxiety

Level of state-trait anxiety

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

2017

Completed Phase 3

~1630

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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 InvestigatorSt. Justine's Hospital

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: NCT05909878 — N/A

Pediatrics Research Study Groups: Virtual Reality Distraction, Standard Treatment

Pediatrics Clinical Trial 2023: Virtual Reality Highlights & Side Effects. Trial Name: NCT05909878 — N/A

Virtual Reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT05909878 — N/A

Frequently Asked Questions

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

Does this research program accept volunteers of advanced age?

"This study's inclusion criteria stipulates that patients should be between the ages of 7 to 17. There are 213 studies available for minors and 527 trials suitable for elderly participants."

Answered by AI

Are there opportunities for enrolment in this trial?

"Indeed, the clinical trial is still open for enrolment. The first listing was posted on May 27th 2022 and revised most recently on June 13th 2023."

Answered by AI

How many individuals are engaging in this clinical experiment?

"That is accurate. According to the clinicaltrials.gov website, this medical research project that was initially published on May 27th 2022 is actively recruiting for 98 participants at one location. It has been recently updated on June 13th 2023."

Answered by AI

Is the opportunity available for me to join this trial?

"To be eligible for this medical investigation, interested participants must have pediatrics and fall between the ages of 7 to 17. A total capacity of 98 patients is available."

Answered by AI

What are the fundamental aims of this investigation?

"The primary outcome of this trial, evaluated over a Change from Baseline (T0) at 15 minutes (T1) and 30 minutes (T2), is the Degree of Anxiety. Secondary outcomes encompass Head Deviation in Space, as quantified through Positioning Cameras within the headset; Heart Rate measured via Biofeedback Device; and Oxygen Saturation tracked by the same means."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality Distraction for Anxiety (VR-IMAGINE at HSJ)

Sylvie Le May 2022. "Virtual Reality Distraction for Anxiety (VR-IMAGINE at HSJ)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05909878.

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