Anxiety, Pain, Severe Aortic Valve Stenosis
Conditions
Keywords
TAVI, VR, 3D glasses
Brief summary
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.
Interventions
OTHERVR during TAVI
Virtual Reality (VR) glasses
Sponsors
Klinik für Kardiologie, Pneumologie und Angiologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety | at Baseline | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of clinical frailty scale | at Baseline | 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). |
| Measurement of pain: visual analog scale | after 24 hours | 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) |
| Length of stay at hospital | up to 5 days | The length of stay at hospital will be recorded. |
| Time of VR | at Baseline | The time \[min\] of VR use will be recorded during the procedure |
| Occurence of nausea | at Baseline, periprocedural and after 24 hours | Patients will be asked during and after the procedure for safety problems with special regards to nausea |
| Rate of Intra-hospital mortality | up to 5 days | The intra-hospital mortality will be assessed after discharge |
| Occurence of vomitting | at Baseline, periprocedural and after 24 hours | Patients will be asked during and after the procedure for safety problems with special regards to vomiting |
Countries
Germany
Outcome results
None listed