VR-relaxation for ECT-related Anxiety

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: ECT-related Anxiety
• Intervention / Treatment: Device: VR-based relaxation; Other: Breathing exercises; Other: Treatment as usual

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • University Hospital Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Within-Subject Experimental Condition Group; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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..	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.	pre- to post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2026
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Virtual Reality; Electroconvulsive Therapy; ECT
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Therapeutics; Breathing Exercises
• Other Study ID Numbers: 1432025000282

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No