Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Aortic Valve Stenosis
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in anxiety
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Klinik für Kardiologie, Pneumologie und Angiologie
Principle Investigator
Heinrich-Heine University, Duesseldorf
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in anxiety
Time Frame: after 24 hours
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 Outcomes
- Time of VR(at Baseline)
- Evaluation of clinical frailty scale(at Baseline)
- Measurement of pain: visual analog scale(after 24 hours)
- Length of stay at hospital(up to 5 days)
- Occurence of vomitting(at Baseline, periprocedural and after 24 hours)
- Occurence of nausea(at Baseline, periprocedural and after 24 hours)
- Rate of Intra-hospital mortality(up to 5 days)