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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Virtual Reality (VR) glasses
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, Germany
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)
Time frame: 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)
Time frame: after 24 hours
Time of VR
The time \[min\] of VR use will be recorded during the procedure
Time frame: 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).
Time frame: 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)
Time frame: after 24 hours
Length of stay at hospital
The length of stay at hospital will be recorded.
Time frame: up to 5 days
Occurence of vomitting
Patients will be asked during and after the procedure for safety problems with special regards to vomiting
Time frame: 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
Time frame: at Baseline, periprocedural and after 24 hours
Rate of Intra-hospital mortality
The intra-hospital mortality will be assessed after discharge
Time frame: up to 5 days
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