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

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses VR to help patients scheduled for ECT by showing them a virtual experience of the procedure. This aims to reduce their anxiety and improve their understanding of ECT. By making patients more familiar with the process, the study hopes to lower their fear and increase the success rate of the treatment. Virtual reality (VR) has been used successfully to treat anxiety disorders and improve patient understanding of medical procedures.

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 data supports the effectiveness of the treatment Virtual Reality Therapy for reducing anxiety?

Research shows that Virtual Reality Therapy can effectively reduce anxiety in conditions like phobias and panic disorders by allowing patients to face their fears in a controlled, virtual environment. This approach has been found to be as effective as traditional exposure therapy, helping patients manage anxiety symptoms. ^{1 2 3 4 5}

Is virtual reality therapy safe for humans?

Virtual reality therapy is generally safe for humans, but it can cause mild and temporary side effects like nausea, dizziness, or headache. These side effects are usually not severe and tend to go away on their own. ^{1 3 4 5 6}

How does virtual reality treatment for pre-procedure anxiety before ECT differ from other treatments?

Virtual reality treatment is unique because it uses an interactive, three-dimensional virtual world to help patients feel like they are 'there', which can be more effective than traditional methods like imagination or in-person exposure. This approach allows for gradual exposure to anxiety-inducing situations in a controlled and realistic environment, which can be particularly beneficial for reducing anxiety before medical procedures. ^{1 5 7 8 9}

Research Team

Fahad Alam

Principal Investigator

SHSC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality assisted cognitive behavioral therapy for the treatment of Panic Disorders with Agoraphobia. [2019]

2. England pubmed.ncbi.nlm.nih.gov

E-virtual reality exposure therapy in acrophobia: A pilot study. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. [2011]

4. Greece pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in anxiety disorders]. [2017]

5. Argentina pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in the care management of anxiety disorders]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. [2012]

7. Canada 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. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Development of virtual reality as an exposure technique]. [2020]