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Virtual Reality for Pre-procedure Anxiety Before ECT (PERFECT-VR Trial)

N/A
Recruiting
Led By Fahad Alam
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Within 2-4 days of ECT procedure or no ECT within the past year
Age ≥18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurement completed prior to ect session on the day of procedure.
Awards & highlights

PERFECT-VR Trial Summary

This trial is studying whether using virtual reality to allow patients to experience a virtual electroconvulsive therapy (ECT) education session before treatment is useful in lowering treatment anxiety and increasing knowledge about ECT if compared to standard treatment.

Who is the study for?
This trial is for adults (18+) who are about to undergo their first ECT session within a year, can understand English, and are able to watch videos and answer questions. It's not for those with visual/hearing issues that prevent video watching, severe motion sickness, or inability to consent.Check my eligibility
What is being tested?
The study tests if a VR experience of an ECT education session before the actual treatment reduces anxiety more effectively than standard preparation with a psychiatrist. Participants will be randomly assigned to one of these two approaches.See study design
What are the potential side effects?
There may be no direct side effects from participating in this trial; however, individuals prone to motion sickness might experience discomfort with VR. The usual risks associated with ECT such as confusion or memory loss are separate from this study.

PERFECT-VR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had an ECT procedure 2-4 days ago or none in the past year.
Select...
I am 18 years old or older.

PERFECT-VR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurement completed 1) up to 2-3 days before ect education 2) right after ect education 3) prior to ect (day of proceudre)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measurement completed 1) up to 2-3 days before ect education 2) right after ect education 3) prior to ect (day of proceudre) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ECT Knowledge
Change in Pre-operative Anxiety
Heart rate
+1 more
Secondary outcome measures
Cognitive Performance
Depression
Ease of Use of VR Technology

PERFECT-VR Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard TreatmentExperimental Treatment1 Intervention
Patients will receive standard preparation for their ECT session.
Group II: Immersive Virtual RealityExperimental Treatment1 Intervention
Patients will be immersed in the ECT experience using VR-ECT 360o video (VR-ECT).

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,558 Total Patients Enrolled
12 Trials studying Anxiety
5,296 Patients Enrolled for Anxiety
Fahad AlamPrincipal InvestigatorSHSC

Media Library

VR-ECT 360o Video Clinical Trial Eligibility Overview. Trial Name: NCT04291196 — N/A
Anxiety Research Study Groups: Immersive Virtual Reality, Standard Treatment
Anxiety Clinical Trial 2023: VR-ECT 360o Video Highlights & Side Effects. Trial Name: NCT04291196 — N/A
VR-ECT 360o Video 2023 Treatment Timeline for Medical Study. Trial Name: NCT04291196 — N/A
Anxiety Patient Testimony for trial: Trial Name: NCT04291196 — N/A

Frequently Asked Questions

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

Are there any openings presently available to participants in this trial?

"According to clinicaltrials.gov, this medical research is currently attempting to recruit volunteers. The trial was initially posted on November 27th 2020 and was last edited on February 14th 2022."

Answered by AI

What is the uppermost limit of participants in this experiment?

"Affirmative. The details on clinicaltrials.gov state that this medical trial is presently enrolling patients and was initially posted to the site on November 27th, 2020 with its most recent update occurring February 14th, 2022. 64 participants are required from a single location for completion of the study."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
North Carolina
How old are they?
18 - 65
What site did they apply to?
Sunnybrook Health Sciences Centre
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Saw an ad and wanted to help further research on anxiety treatments.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long is the study? Is there compensation?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Sunnybrook Health Sciences Centre: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT
2020. "Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04291196.
All > Generalized Anxiety Disorder > Treatment Resistant Depression
~10 spots leftby Dec 2024
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