What side effects are associated with this type of intervention?

Common treatments for anxiety include cognitive-behavioral therapy (CBT), pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), and non-pharmacologic interventions like relaxation techniques and psychoeducation. CBT is generally well-tolerated with minimal side effects, though it may initially increase anxiety as patients confront their fears. SSRIs and SNRIs can cause side effects such as nausea, insomnia, sexual dysfunction, and weight gain. Non-pharmacologic interventions like relaxation techniques typically have few side effects but may not be effective for all patients. The VR ECT education session aims to reduce anxiety and increase knowledge, potentially offering a side-effect-free alternative to traditional methods.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of anxiety, including selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine, and benzodiazepines like alprazolam and diazepam. While there are no specific FDA approvals for immersive simulation or virtual reality-based treatments for anxiety, these innovative approaches are being studied for their potential to reduce anxiety by providing educational and immersive experiences that can help patients better understand and manage their conditions.

What other types of research exist?

Promising, novel alternatives to Virtual Reality (VR) ECT Education Sessions for anxiety patients considering treatment in 2024 include Augmented Reality (AR) experiences, interactive mobile applications with gamification, telehealth sessions with mental health professionals, biofeedback and neurofeedback techniques, and mindfulness and relaxation apps.

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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

Must not have

Visual and hearing impairments precluding the ability to watch or listen to video

Lack of patient consent or capacity to give consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurement completed prior to ect session on the day of procedure.

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I am unable to give consent for the trial.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ECT Knowledge

Change in Pre-operative Anxiety

Heart rate

+1 more

Secondary study objectives

Cognitive Performance

Depression

Ease of Use of VR Technology

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Virtual Reality (VR) treatments for anxiety work by creating immersive, controlled environments where patients can safely confront and manage their anxiety triggers. This exposure helps desensitize patients to anxiety-provoking stimuli, reducing overall anxiety levels. Additionally, VR can deliver educational content in an engaging manner, increasing patient knowledge and reducing fear of the unknown. This approach is significant for anxiety patients as it offers a non-invasive, interactive, and effective method to manage and reduce anxiety symptoms, potentially improving their quality of life.

Cinematic virtual reality for anxiety management in mechanically ventilated patients: a feasibility and pilot study.Virtual reality in anxiety disorders: the past and the future.