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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
- Contra-indications for VR: photosensitive epilepsy, severe travel sickness, vertigo, open wounds on the face
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brussels | Brussels | 1090 | Belgium |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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| Breathing exercises | Other | Participants will perform a guided breathing exercises session. |
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| Treatment as usual | Other | Participants will receive treatment as usual without any additional relaxation intervention during this condition. |
|
| 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 |