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Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT

Virtual Reality as a Tool to Reduce Pre-procedure Anxiety Prior ECT Via Enhancing Patient Education

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04291196
Acronym
PERFECT-VR
Enrollment
66
Registered
2020-03-02
Start date
2020-11-27
Completion date
2024-09-10
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Cognition, Depression, ECT, Education, Electroconvulsive Therapy, Hemodynamics, Mental Health, Virtual Reality

Brief summary

Lack of patient knowledge about ECT (electroconvulsive therapy) is a leading cause of treatment fear with 60% of ECT patients reporting high levels of anxiety. The purpose of this study is to determine if using Virtual Reality (VR) to allow patients' to experience a virtual ECT education session before treatment is useful in lowering treatment anxiety and increasing knowledge about ECT if compared to standard treatment. In addition, measuring heart rate and blood pressure levels before ECT treatment will allow us to assess changes in anxiety levels. Individuals who choose to participate will be placed (participant will have a 50% chance to be placed in either group) to view either a virtual reality video to experience a virtual ECT session, or to receive standard preparation, i.e. a discussion with a psychiatrist. Before and after this session participants will be asked to complete a measurement of their anxiety level and knowledge about ECT (ECT Attitude & Knowledge Questionnaire). Just before ECT treatment, blood pressure, heart rate and anxiety level will be measured. Participants will also complete cognitive and depression assessments. This study will help to develop a relationship between healthcare providers and patients and their families to help with education before ECT treatment.

Detailed description

Virtual reality (VR) is increasingly being used in healthcare, in particular as a form of exposure therapy for patients with psychiatric disorders. It immerses patients into hospital-based procedures. We and others showed that VR prep reduces anxiety levels for elective surgical patients (manuscript submitted). However, the efficacy of VR in reducing peri-procedural anxiety in vulnerable psychiatric populations has not been assessed. This will be the first RCT utilizing VR to reduce patient anxiety before ECT through education. If VR education reduces anxiety in this vulnerable population (as proof of concept), it could increase ECT success by decreasing anesthetic requirements. Using VR technology, our study will provide patients and their families with a balanced and in-depth look at ECT safety and efficacy, and its recent advances in management of psychiatric disorders. Primary objectives of this study are to assess whether creating a VR-ECT-360 video that immerses and educates patients and their families in the ECT experience 1) enhances factual knowledge and reduces stigmatizing attitudes toward ECT, and 2) reduces pre-procedure anxiety as compared to traditional 2D video. The secondary objective is to investigate the ease of use of VR technology in a vulnerable psychiatric patient population. Given the high rate of treatment refusals in this population, we hypothesize that implementation of our approach will reduce anxiety through patient education thereby decreasing chances for treatment refusal and drop-out rates. We suggest that use of VR will be a clinically relevant approach in such a vulnerable population (as proof of concept) and could increase ECT success by decreasing anesthetic requirements (anesthetics suppress desired seizure activity).

Interventions

OTHERVR-ECT 360o Video

Patients in the VR arm will be immersed in the ECT process in first person utilizing Google Cardboard headsets. Patients will experience in 360 entering the procedure room, IV insertion, pretreatment checks, anesthetic induction followed by induction of seizure, and recovery. The experience will also have voice-over narration simultaneously describing the procedure and its risks and benefits.

OTHERStandard Treatment

Patients will receive preparation for their ECT as per standard of care, i.e. a discussion with a Psychiatrist.

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 * First time undergoing ECT within the last year * Outpatient/inpatient recommended for ECT * Within 2-4 days of ECT procedure or no ECT within the past year * Referred by psychiatrist * Able to understand English * Able to watch and respond to questions

Exclusion criteria

* Lack of patient consent or capacity to give consent * Visual and hearing impairments precluding the ability to watch or listen to video * History of significant motion sickness (i.e. occur during exposure to physical, visual and virtual motion, cybersickness verbally declared by patient)

Design outcomes

Primary

MeasureTime frameDescription
Change in Pre-operative AnxietyMeasurement completed 1) up to 2-3 days before ECT education 2) right after ECT education 3) prior to ECT (day of proceudre)Change in pre-operative anxiety will be assessed using the Visual Anxiety Scale (VAS, Not at all anxious to extremely anxious).
Change in ECT KnowledgeMeasurement completed 1) Immediately Before ECT education 2) Immediately After ECT education 3) Immediately Prior to ECTChange in ECT knowledge will be assessed using the ECT Attitude \& Knowledge Questionnaire.
Heart rateMeasurement completed prior to ECT session on the day of procedure.Heart rate will be measured in beats/min
Mean arterial blood pressureMeasurement completed prior to ECT session on the day of procedure.Mean arterial blood pressure will be measured in mmHg.

Secondary

MeasureTime frameDescription
Cognitive PerformanceMeasurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedureCognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA).
DepressionMeasurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedureDepression will be assessed.
Ease of Use of VR TechnologyMeasurement completed immediately after ECT education on the day of procedure.Ease of use of VR technology will be assessed using the system usability, scale (SUS), only in VR arm.

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORFahad Alam

SHSC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026