Virtual Reality for Pre-procedure Anxiety Before ECT

(PERFECT-VR Trial)

Overseen By Lilia Kaustov, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Lack of consent, Visual impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can reduce anxiety and improve understanding for individuals about to undergo electroconvulsive therapy (ECT). Participants will either experience a VR session simulating ECT or have a standard chat with a psychiatrist before their treatment. Researchers will measure anxiety, knowledge, blood pressure, and heart rate to determine if VR makes a difference. Eligible participants are those trying ECT for the first time within the past year and referred by a psychiatrist. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance patient experiences during ECT.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual reality method is safe for reducing pre-procedure anxiety?

Research has shown that virtual reality (VR) therapy is generally safe. Some individuals might experience mild side effects such as nausea, dizziness, or headaches, but these typically resolve quickly. One study found that using VR with surgery patients reduced their pre-operative anxiety. This suggests that VR could be a useful tool without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) to ease anxiety before electroconvulsive therapy (ECT) because it offers a totally immersive experience that traditional methods can't match. Unlike standard preparation, which often involves verbal explanations and counseling, VR lets patients 'experience' what the ECT process will be like in a controlled, 360-degree video environment. This innovative approach aims to reduce fear and anxiety by familiarizing patients with the procedure in advance, potentially improving their overall experience and cooperation with ECT.

What evidence suggests that Virtual Reality is effective for reducing pre-procedure anxiety before ECT?

Research has shown that Virtual Reality (VR) therapy can help reduce anxiety. Studies have found that VR places patients in a virtual setting, which can lower anxiety before medical procedures. For individuals with anxiety disorders, VR therapy has effectively improved anxiety levels. One study discovered that using VR before surgeries reduced patients' anxiety. In this trial, participants will be assigned to different treatment arms: one group will experience Immersive Virtual Reality to ease anxiety before undergoing ECT (electroconvulsive therapy), while another group will receive standard preparation for their ECT session. ^{1 2 3 4 6}

Who Is on the Research Team?

Fahad Alam

Principal Investigator

SHSC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You can understand and communicate in English.

I had an ECT procedure 2-4 days ago or none in the past year.

I was referred to a psychiatrist by my family doctor

Exclusion Criteria

You get very nauseous or dizzy when you experience motion, such as when you're on a boat or playing video games.

I cannot see or hear well enough to watch or listen to videos.

I am unable to give consent for the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Procedure Education

Participants receive either a virtual reality video experience of an ECT session or standard preparation with a psychiatrist discussion.

1 day

1 visit (in-person)

ECT Treatment

Participants undergo the ECT procedure with pre-procedure anxiety and physiological measures taken.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety, cognitive performance, and depression after the ECT treatment.

2-3 days

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard Treatment Experimental Treatment 1 Intervention

Patients will receive standard preparation for their ECT session.

Group II: Immersive Virtual Reality Experimental Treatment 1 Intervention

Patients will be immersed in the ECT experience using VR-ECT 360o video (VR-ECT).

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

Virtual reality therapy is proposed as an effective alternative to traditional exposure methods in cognitive behavioral therapy for anxiety disorders, showing at least equivalent efficacy to in vivo exposure for conditions like specific phobias and PTSD.

The immersive nature of virtual reality creates a strong sense of 'presence,' enhancing the therapeutic experience and suggesting that it may function as an embodied therapy rather than just a method of exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in the care management of anxiety disorders]. Levy, F., Rautureau, G., Jouvent, R.[2019]

Virtual reality exposure therapy (VRET) significantly outperforms waitlist controls in treating anxiety disorders, indicating its effectiveness as an intervention.

When compared to traditional evidence-based treatments, VRET shows similar efficacy and stability of results over time, suggesting it can be a viable alternative or complement to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. Opriş, D., Pintea, S., García-Palacios, A., et al.[2012]

Virtual Reality Based Exposure Therapy (VRBET) showed positive effects in treating agoraphobia in a trial with 10 participants, indicating its potential as an effective standalone treatment.

Combining VRBET with cognitive therapy did not result in significant improvements over VRBET alone, suggesting that VRBET may be sufficient for addressing agoraphobia without the need for additional cognitive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. Malbos, E., Rapee, RM., Kavakli, M.[2011]

The study aims to evaluate a virtual reality exposure (VRE) tool designed to prepare children aged 4 to 12 for surgery, with a focus on reducing preoperative anxiety and improving overall surgical experience, in a randomized controlled trial involving 200 participants.

The VRE intervention is expected to significantly reduce preoperative anxiety, postoperative pain, and the need for analgesics, potentially leading to a less stressful experience for both children and their parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial. Eijlers, R., Legerstee, JS., Dierckx, B., et al.[2020]

Virtual reality (VR) exposure therapy has been shown to be effective for treating anxiety disorders, with a growing focus on complex conditions like social anxiety disorder, beyond just specific phobias.

The advancement of VR technology has established it as both a therapeutic tool and a research method, highlighting the need for further studies on its efficacy in treating various anxiety disorders and understanding the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of virtual reality as an exposure technique]. Diemer, J., Zwanzger, P.[2020]

Virtual reality exposure therapy (VRET) has emerged as a promising alternative for treating anxiety disorders, particularly in cases where traditional imaginal exposure therapy is challenging to implement, allowing for controlled exposure to phobic stimuli in a safe environment.

High levels of 'immersion' and 'presence' during VRET are linked to better therapeutic outcomes, enabling therapists to tailor exposure intensity to individual patient needs, although the technology requires specialized training and can have mild side effects like nausea or dizziness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in anxiety disorders]. Mitrousia, V., Giotakos, O.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04291196

Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT Just before ECT treatment, blood pressure, heart rate and anxiety level will be measured. Participants will also complete cognitive and depression assessments.

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/243775

Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT The purpose of this study is to determine if using Virtual Reality (VR) to allow patients' to experience a virtual ECT education session before ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904249/

Effectiveness of virtual reality therapy in the treatment ... The current findings suggest that VR therapy interventions have a positive effect on improving the anxiety state of patients with anxiety disorders.

4. clinicaltrial.be clinicaltrial.be/en/details/57613?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT... It immerses patients into hospital-based procedures. We and others showed that VR prep reduces anxiety levels for elective surgical patients ( ...

5. withpower.com withpower.com/trial/phase-anxiety-disorders-10-2020-19d85

Virtual Reality for Pre-procedure Anxiety Before ECT Virtual Reality Based Exposure Therapy (VRBET) showed positive effects in treating agoraphobia in a trial with 10 participants, indicating its potential as an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10618840/

Virtual Reality–Based Intervention to Reduce Preoperative ... This randomized clinical trial of 74 adult patients undergoing elective surgery found that a virtual reality–based intervention was effective in reducing ...