VR-relaxation for ECT-related Anxiety

NCT07546526 — Not applicable, Enrolling by invitation, 20 participants, Universitair Ziekenhuis Brussel

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Effectiveness of Virtual Reality-based Relaxation on Electroconvulsive Therapy-related Anxiety

Registry	NCT07546526
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	20 (Estimated)
Sponsor	Universitair Ziekenhuis Brussel (Other)
Conditions	ECT-related Anxiety
Interventions	VR-based relaxation, Breathing exercises, Treatment as usual (Device, other)
Dates	start 2026-03-12, primary completion 2032-12-31 (estimated), completion 2032-12-31 (estimated), first posted 2026-04-22, last updated 2026-04-22
Locations	1 site in Belgium

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Within-Subject Experimental Condition Group	Experimental	Device: VR-based relaxation; Other: Breathing exercises; Other: Treatment as usual	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.

VR-based relaxation (Device): Participants will receive a relaxation session using VR-goggles prior to their ECT. The VR session includes immersive calming visuals and audio.
Breathing exercises (Other): Participants will perform a guided breathing exercises session.
Treatment as usual (Other): Participants will receive treatment as usual without any additional relaxation intervention during this condition.

+Outcome measures

Primary outcomes

Change in anxiety levels (BAI) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU). [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). [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.

Secondary outcomes

Improvement in stress symptom (VAS-Stress) score after VR relaxation in comparison to breathing exercises and TAU. [Pre-intervention and post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.]: Measured through the Visual Analogue Scale for Stress (VAS-Stress), scale 0-10, higher scores indicate greater stress.
Improvement in stress symptom (heart rate) score after VR relaxation in comparison to breathing exercises and TAU. [Pre- and post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.]: Measured through the heart rate in beats per minute (bpm), higher values indicate increased physiological arousal.
The effect of depression severity on the effectivity of VR-based relaxation. [Baseline]: Measured through the Beck Depression Inventory (BDI), score 0-63, higher scores indicate more severe depression.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

\- Contra-indications for VR: photosensitive epilepsy, severe travel sickness, vertigo, open wounds on the face

+Locations (1)

Facility	City	Country	Status
University Hospital Brussels	Brussels	Belgium