ECT-related AnxietyNCT07546526
VR-relaxation for ECT-related Anxiety
A study testing VR-based relaxation, Breathing exercises and Treatment as usual in people with ECT-related Anxiety, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to learn if there is an effect of Virtual Reality (VR) based-relaxation on electroconvulsive therapy (ECT)-related anxiety. The main questions it aims to answer are: Does VR based-relaxation have an effect on anxiety in patients receiving ECT as part of routine clinical care? Does VR… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ECT-related Anxiety
- What is being tested?
- VR-based relaxation, Breathing exercises and Treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Mar 2026to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Being treated with ECT, having had at least two sessions at study start
- Able to understand study procedure and sign informed consent
- Speaking Dutch or French
- DSM-5 diagnosis of a depressive disorder, for which ECT treatment has been initiated
Who cannot join
- Contra-indications for VR: photosensitive epilepsy, severe travel sickness, vertigo, open wounds on the face
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Virtual Reality-based Relaxation on Electroconvulsive Therapy-related Anxiety
The goal of this clinical trial is to learn if there is an effect of Virtual Reality (VR) based-relaxation on electroconvulsive therapy (ECT)-related anxiety. The main questions it aims to answer are:
- Does VR based-relaxation have an effect on anxiety in patients receiving ECT as part of routine clinical care?
- Does VR based-relaxation have an effect on stress symptoms and heart rate in patients receiving ECT as part of routine clinical care?
- Does depression severity have an effect on the effectivity of VR-based relaxation
Researchers will compare VR-relaxation to relaxation breathing exercises and no relaxation to see if VR-based relaxation has an effect on ECT-related anxiety.
- Conditions
- ECT-related Anxiety
- Being tested
- VR-based relaxation, Breathing exercises, Treatment as usual
- Keywords
- Anxiety, ECT, Electroconvulsive Therapy, Depression, Virtual Reality
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based relaxationDevice
Participants will receive a relaxation session using VR-goggles prior to their ECT. The VR session includes immersive calming visuals and audio.
Breathing exercisesOther
Participants will perform a guided breathing exercises session.
Treatment as usualOther
Participants will receive treatment as usual without any additional relaxation intervention during this condition.
| Study group | Role | What they receive |
|---|---|---|
| Within-Subject Experimental Condition Group | Experimental | Participants will undergo three experimental conditions (each twice and in random order): (1) VR-relaxation, (2) breathing exercises, and (3) treatment as usual (TAU, no additional intervention). Each participant serves as their own control. Receives: Device: VR-based relaxation; Other: Breathing exercises; Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety levels (BAI) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU).
Measured through the Beck Anxiety Inventory (BAI), score 0-63, higher scores indicate more severe anxiety..
Measured: Pre-intervention to post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.
Change in anxiety levels (VAS-anxiety) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU).
Measured through the Visual Analogue Scale for Anxiety (VAS-Anxiety), scale 0-10, higher scores indicate greater anxiety.
Measured: pre- to post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.
Secondary outcomes (3)
Improvement in stress symptom (VAS-Stress) score after VR relaxation in comparison to breathing exercises and TAU.
Measured through the Visual Analogue Scale for Stress (VAS-Stress), scale 0-10, higher scores indicate greater stress.
Measured: Pre-intervention and post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.
Improvement in stress symptom (heart rate) score after VR relaxation in comparison to breathing exercises and TAU.
Measured through the heart rate in beats per minute (bpm), higher values indicate increased physiological arousal.
Measured: Pre- and post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.
The effect of depression severity on the effectivity of VR-based relaxation.
Measured through the Beck Depression Inventory (BDI), score 0-63, higher scores indicate more severe depression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start12 Mar 2026
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECT-related AnxietyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546526
- Sponsor's protocol ID
- 1432025000282
- Status last verified
- Feb 2026
- First submitted
- 12 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality-based Relaxation on Electroconvulsive Therapy-related Anxiety
- ClinicalTrials.gov ID
- NCT07546526
- Acronym / sponsor ID
- 1432025000282
- Conditions
- ECT-related Anxiety
- Keywords
- Anxiety, ECT, Electroconvulsive Therapy, Depression, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 22 Apr 2026 (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.
The goal of this clinical trial is to learn if there is an effect of Virtual Reality (VR) based-relaxation on electroconvulsive therapy (ECT)-related anxiety. The main questions it aims to answer are:
- Does VR based-relaxation have an effect on anxiety in patients receiving ECT as part of routine clinical care?
- Does VR based-relaxation have an effect on stress symptoms and heart rate in patients receiving ECT as part of routine clinical care?
- Does depression severity have an effect on the effectivity of VR-based relaxation
Researchers will compare VR-relaxation to relaxation breathing exercises and no relaxation to see if VR-based relaxation has an effect on ECT-related anxiety.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Within-Subject Experimental Condition Group | Experimental | Device: VR-based relaxation, Other: Breathing exercises, Other: Treatment as usualParticipants will undergo three experimental conditions (each twice and in random order): (1) VR-relaxation, (2) breathing exercises, and (3) treatment as usual (TAU, no additional intervention). Each participant serves as their own control. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years
- Being treated with ECT, having had at least two sessions at study start
- Able to understand study procedure and sign informed consent
- Speaking Dutch or French
- DSM-5 diagnosis of a depressive disorder, for which ECT treatment has been initiated
Key exclusion criteria (1 listed)
- Contra-indications for VR: photosensitive epilepsy, severe travel sickness, vertigo, open wounds on the face
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-based relaxationParticipants will receive a relaxation session using VR-goggles prior to their ECT. The VR session includes immersive calming visuals and audio. | Device | Within-Subject Experimental Condition Group |
| Breathing exercisesParticipants will perform a guided breathing exercises session. | Other | Within-Subject Experimental Condition Group |
| Treatment as usualParticipants will receive treatment as usual without any additional relaxation intervention during this condition. | Other | Within-Subject Experimental Condition Group |
Primary outcome
Change in anxiety levels (BAI) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU).
Time frame: Pre-intervention to post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.
Measured through the Beck Anxiety Inventory (BAI), score 0-63, higher scores indicate more severe anxiety..
Change in anxiety levels (VAS-anxiety) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU).
Time frame: pre- to post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.
Measured through the Visual Analogue Scale for Anxiety (VAS-Anxiety), scale 0-10, higher scores indicate greater anxiety.
3 secondary outcomes
Improvement in stress symptom (VAS-Stress) score after VR relaxation in comparison to breathing exercises and TAU.
Time frame: Pre-intervention and post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.
Improvement in stress symptom (heart rate) score after VR relaxation in comparison to breathing exercises and TAU.
Time frame: Pre- and post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.
The effect of depression severity on the effectivity of VR-based relaxation.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-based relaxation, Breathing exercises and Treatment as usual in people with ECT-related Anxiety, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 5 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 22 Apr 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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 anxiety levels (BAI) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU). (time frame: Pre-intervention to post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.). The study lists 2 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 22 Apr 2026.