ECTPERFECT-VRNCT04291196
Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT
A study testing VR-ECT 360o Video and Standard Treatment in people with ECT and Electroconvulsive Therapy, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ECT, Electroconvulsive Therapy, Virtual Reality
- What is being tested?
- VR-ECT 360o Video and Standard Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2020to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality as a Tool to Reduce Pre-procedure Anxiety Prior ECT Via Enhancing Patient Education
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.
Read more
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.
Read the 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).
- Conditions
- ECT, Electroconvulsive Therapy, Virtual Reality, Anxiety, Education, Hemodynamics
- Being tested
- VR-ECT 360o Video, Standard Treatment
- Medical subject headings
- Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-ECT 360o VideoOther
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.
Standard TreatmentOther
Patients will receive preparation for their ECT as per standard of care, i.e. a discussion with a Psychiatrist.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality | Experimental | Patients will be immersed in the ECT experience using VR-ECT 360o video (VR-ECT). Receives: Other: VR-ECT 360o Video |
| Standard Treatment | Other | Patients will receive standard preparation for their ECT session. Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Measurement completed 1) up to 2-3 days before ECT education 2) right after ECT education 3) prior to ECT (day of proceudre)
Change in ECT Knowledge
Change in ECT knowledge will be assessed using the ECT Attitude \& Knowledge Questionnaire.
Measured: Measurement completed 1) Immediately Before ECT education 2) Immediately After ECT education 3) Immediately Prior to ECT
Heart rate
Heart rate will be measured in beats/min
Measured: Measurement completed prior to ECT session on the day of procedure.
Mean arterial blood pressure
Mean arterial blood pressure will be measured in mmHg.
Measured: Measurement completed prior to ECT session on the day of procedure.
Secondary outcomes (3)
Cognitive Performance
Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA).
Measured: Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure
Depression
Depression will be assessed.
Measured: Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure
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.
Measured: Measurement completed immediately after ECT education on the day of procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start27 Nov 2020
- Primary completion3 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECTStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fahad Alam, Principal investigator, SHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291196
- Sponsor's protocol ID
- 036-2019
- Acronym
- PERFECT-VR
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2019
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Tool to Reduce Pre-procedure Anxiety Prior ECT Via Enhancing Patient Education
- ClinicalTrials.gov ID
- NCT04291196
- Acronym / sponsor ID
- PERFECT-VR / 036-2019
- Conditions
- ECT, Electroconvulsive Therapy, Virtual Reality, Anxiety, Education, Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality | Experimental | Other: VR-ECT 360o VideoPatients will be immersed in the ECT experience using VR-ECT 360o video (VR-ECT). |
| Standard Treatment | Other | Other: Standard TreatmentPatients will receive standard preparation for their ECT session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-ECT 360o VideoPatients 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. | Other | Immersive Virtual Reality |
| Standard TreatmentPatients will receive preparation for their ECT as per standard of care, i.e. a discussion with a Psychiatrist. | Other | Standard Treatment |
Primary outcome
Change in Pre-operative Anxiety
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)
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
Time frame: Measurement completed 1) Immediately Before ECT education 2) Immediately After ECT education 3) Immediately Prior to ECT
Change in ECT knowledge will be assessed using the ECT Attitude \& Knowledge Questionnaire.
Heart rate
Time frame: Measurement completed prior to ECT session on the day of procedure.
Heart rate will be measured in beats/min
Mean arterial blood pressure
Time frame: Measurement completed prior to ECT session on the day of procedure.
Mean arterial blood pressure will be measured in mmHg.
3 secondary outcomes
Cognitive Performance
Time frame: Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure
Depression
Time frame: Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure
Ease of Use of VR Technology
Time frame: Measurement completed immediately after ECT education on the day of procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for ECT
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Not yet recruiting
Peri-procedural Weighted Blanket Use for ECT
Post-ect Agitation, Post-ictal Agitation
Not yet recruitingObservational study
Longitudinal Effects of Brain Stimulation on Decision-Making and Reward Learning
Depression / Major Depressive Disorder
Not yet recruiting
Evaluating the Therapeutic Potential of Focal Electrically Administered Seizure Therapy (FEAST) in the Treatment of Depression: A Multicenter Randomized Clinical Trial
Major Depressive Episode (MDE), Unipolar Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahad Alam principal investigator
SHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-ECT 360o Video and Standard Treatment in people with ECT and Electroconvulsive Therapy, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pre-operative Anxiety (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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.