Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT (PERFECT-VR)
Primary Purpose
ECT, Electroconvulsive Therapy, Virtual Reality
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
VR-ECT 360o Video
Standard Treatment
Sponsored by
About this trial
This is an interventional other trial for ECT
Eligibility Criteria
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)
Sites / Locations
- Sunnybrook Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immersive Virtual Reality
Standard Treatment
Arm Description
Patients will be immersed in the ECT experience using VR-ECT 360o video (VR-ECT).
Patients will receive standard preparation for their ECT session.
Outcomes
Primary Outcome Measures
Change in Pre-operative Anxiety
Change in pre-operative anxiety will be assessed using the Visual Anxiety Scale (VAS, Not at all anxious to extremely anxious).
Change in ECT Knowledge
Change in ECT knowledge will be assessed using the ECT Attitude & Knowledge Questionnaire.
Heart rate
Heart rate will be measured in beats/min
Mean arterial blood pressure
Mean arterial blood pressure will be measured in mmHg.
Secondary Outcome Measures
Cognitive Performance
Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA).
Depression
Depression will be assessed.
Ease of Use of VR Technology
Ease of use of VR technology will be assessed using the system usability, scale (SUS), only in VR arm.
Full Information
NCT ID
NCT04291196
First Posted
November 12, 2019
Last Updated
April 12, 2023
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT04291196
Brief Title
Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT
Acronym
PERFECT-VR
Official Title
Virtual Reality as a Tool to Reduce Pre-procedure Anxiety Prior ECT Via Enhancing Patient Education
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 27, 2020 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ECT, Electroconvulsive Therapy, Virtual Reality, Anxiety, Education, Hemodynamics, Depression, Cognition, Mental Health
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immersive Virtual Reality
Arm Type
Experimental
Arm Description
Patients will be immersed in the ECT experience using VR-ECT 360o video (VR-ECT).
Arm Title
Standard Treatment
Arm Type
Other
Arm Description
Patients will receive standard preparation for their ECT session.
Intervention Type
Other
Intervention Name(s)
VR-ECT 360o Video
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Treatment
Intervention Description
Patients will receive preparation for their ECT as per standard of care, i.e. a discussion with a Psychiatrist.
Primary Outcome Measure Information:
Title
Change in Pre-operative Anxiety
Description
Change in pre-operative anxiety will be assessed using the Visual Anxiety Scale (VAS, Not at all anxious to extremely anxious).
Time Frame
Measurement completed 1) up to 2-3 days before ECT education 2) right after ECT education 3) prior to ECT (day of proceudre)
Title
Change in ECT Knowledge
Description
Change in ECT knowledge will be assessed using the ECT Attitude & Knowledge Questionnaire.
Time Frame
Measurement completed 1) Immediately Before ECT education 2) Immediately After ECT education 3) Immediately Prior to ECT
Title
Heart rate
Description
Heart rate will be measured in beats/min
Time Frame
Measurement completed prior to ECT session on the day of procedure.
Title
Mean arterial blood pressure
Description
Mean arterial blood pressure will be measured in mmHg.
Time Frame
Measurement completed prior to ECT session on the day of procedure.
Secondary Outcome Measure Information:
Title
Cognitive Performance
Description
Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA).
Time Frame
Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure
Title
Depression
Description
Depression will be assessed.
Time Frame
Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure
Title
Ease of Use of VR Technology
Description
Ease of use of VR technology will be assessed using the system usability, scale (SUS), only in VR arm.
Time Frame
Measurement completed immediately after ECT education on the day of procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fahad Alam, MD, M.Sc.
Phone
416-480-4864
Ext
4798
Email
Fahad.Alam@Sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lilia Kaustov, PhD
Phone
416-480-6100
Ext
89607
Email
lilia.kaustov@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahad Alam
Organizational Affiliation
SHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
416-480 4864
Email
fahad.alam@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
MD
Phone
416-480-5318
Email
peter.giacobbe@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Fahad Alam, MD
First Name & Middle Initial & Last Name & Degree
Peter Giacobbe, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT
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