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Enrolling by Invitation

NCT Number: NCT07546526

VR-relaxation for ECT-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.

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Key information

Conditions

ECT-related Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Brussels

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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..

  2. 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.

Secondary outcomes

  1. 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.

    Measured through the Visual Analogue Scale for Stress (VAS-Stress), scale 0-10, higher scores indicate greater stress.

  2. 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.

    Measured through the heart rate in beats per minute (bpm), higher values indicate increased physiological arousal.

  3. The effect of depression severity on the effectivity of VR-based relaxation.

    Time frame: Baseline

    Measured through the Beck Depression Inventory (BDI), score 0-63, higher scores indicate more severe depression.

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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