Brief Title
Virtual Reality Assisted Conscious Sedation During TAVI
Official Title
Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study
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.
Study Type
Interventional
Primary Outcome
Change in anxiety
Secondary Outcome
Time of VR
Condition
Severe Aortic Valve Stenosis
Intervention
VR during TAVI
Study Arms / Comparison Groups
Intervention
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
20
Start Date
November 1, 2019
Completion Date
June 1, 2020
Primary Completion Date
June 1, 2020
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04259723
Organization ID
19-007
Responsible Party
Sponsor-Investigator
Study Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Study Sponsor
, ,
Verification Date
June 2020