NCT07546526

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
81mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Mar 2026Dec 2032

First Submitted

Initial submission to the registry

March 12, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

April 22, 2026

Status Verified

February 1, 2026

Enrollment Period

6.8 years

First QC Date

March 12, 2026

Last Update Submit

April 16, 2026

Conditions

ECT-related Anxiety

Keywords

AnxietyECTElectroconvulsive TherapyDepressionVirtual Reality

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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.

  • 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.

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

    Baseline

Study Arms (1)

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.

Device: VR-based relaxationOther: Breathing exercisesOther: Treatment as usual

Interventions

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.

Within-Subject Experimental Condition Group
Breathing exercisesOTHER

Participants will perform a guided breathing exercises session.

Within-Subject Experimental Condition Group
Treatment as usualOTHER

Participants will receive treatment as usual without any additional relaxation intervention during this condition.

Within-Subject Experimental Condition Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brussels

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Breathing ExercisesTherapeutics

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2026

First Posted

April 22, 2026

Study Start

March 12, 2026

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Last Updated

April 22, 2026

Record last verified: 2026-02

Locations

BE(1)