Virtual Reality Assisted Conscious Sedation During TAVI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Severe Aortic Valve Stenosis Anxiety Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

VR during TAVI

Intervention Type OTHER

Virtual Reality (VR) glasses

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VR during TAVI

Virtual Reality (VR) glasses

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No