Virtual Reality Assisted Conscious Sedation During TAVI

Not Applicable

Completed

• Conditions: Severe Aortic Valve Stenosis; Anxiety; Pain
• Interventions: Other: VR during TAVI

• Registration Number: NCT04259723
• Lead Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Status Verified: 2020-06
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	VR during TAVI	-

Primary Outcome Measures

Name	Time	Method
Change in anxiety	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 Outcome Measures

Name	Time	Method
Time of VR	at Baseline	The time \[min\] of VR use will be recorded during the procedure
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.
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
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

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Duesseldorf, Germany