ECT-related Anxiety
Conditions
Keywords
Anxiety, ECT, Electroconvulsive Therapy, Depression, Virtual Reality
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.
Interventions
DEVICEVR-based relaxation
Participants will receive a relaxation session using VR-goggles prior to their ECT. The VR session includes immersive calming visuals and audio.
OTHERBreathing exercises
Participants will perform a guided breathing exercises session.
OTHERTreatment as usual
Participants will receive treatment as usual without any additional relaxation intervention during this condition.
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium
Outcome results
None listed