VR-relaxation for ECT-related Anxiety
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR-based relaxation, Breathing exercises, Treatment as usual.
- Who it may be relevant to
- Registry conditions: ECT-related Anxiety. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Virtual Reality-based Relaxation on Electroconvulsive Therapy-related Anxiety
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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.]
- 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.]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Belgium · 1 center
- University Hospital Brussels — Brussels
Identifiers
NCT: NCT07546526 · 1432025000282