Virtual Reality Assisted Conscious Sedation During TAVI

Study Overview
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Brief Summary
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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.

Official Title
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Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study

Conditions
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Severe Aortic Valve Stenosis, Anxiety, Pain

Intervention / Treatment
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* Other: VR during TAVI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Interventional transfemoral TAVI Informed consent Normal or corrected vision (through glasses) Exclusion Criteria: Patients whose communication is limited due to a language barrier Patients who could not watch the 3D video due to uncorrectable vision all patients with transapical TAVI were also excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Other: VR during TAVI<br>* Virtual Reality (VR) glasses<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, VR, 3D glasses