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Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. The aim of this prospective, randomized investigation is to prove the feasibility and safety of VR interventions in patients undergoing conscious sedation during TAVI with local anesthesia only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR during TAVI | Other | Virtual Reality (VR) glasses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety | A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious) | at Baseline |
| Change in anxiety | A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious) | after 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time of VR | The time [min] of VR use will be recorded during the procedure | at Baseline |
| Evaluation of clinical frailty scale | The Clinical Frailty Scale (CFS) is a simple model visually describing patients physical conditions with nine classes from very fit (class 1) to terminally ill (class 9). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Pulmonary Disease and Vascular Medicine | Düsseldorf | 40225 | Germany |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| at Baseline |
| Measurement of pain: visual analog scale | A visual analog scale will be used to determine the level of pain after the procedure. A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no pain, 10=unbearable pain) | after 24 hours |
| Length of stay at hospital | The length of stay at hospital will be recorded. | up to 5 days |
| Occurence of vomitting | Patients will be asked during and after the procedure for safety problems with special regards to vomiting | at Baseline, periprocedural and after 24 hours |
| Occurence of nausea | Patients will be asked during and after the procedure for safety problems with special regards to nausea | at Baseline, periprocedural and after 24 hours |
| Rate of Intra-hospital mortality | The intra-hospital mortality will be assessed after discharge | up to 5 days |
| D014694 |
| Ventricular Outflow Obstruction |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |