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Virtual Reality Assisted Conscious Sedation During TAVI (TAVI_VR)

Primary Purpose

Severe Aortic Valve Stenosis, Anxiety, Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
VR during TAVI
Sponsored by
Klinik für Kardiologie, Pneumologie und Angiologie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Severe Aortic Valve Stenosis focused on measuring TAVI, VR, 3D glasses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Change in anxiety
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)
Change in anxiety
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

Time of VR
The time [min] of VR use will be recorded during the procedure
Evaluation of clinical frailty scale
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
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
The length of stay at hospital will be recorded.
Occurence of vomitting
Patients will be asked during and after the procedure for safety problems with special regards to vomiting
Occurence of nausea
Patients will be asked during and after the procedure for safety problems with special regards to nausea
Rate of Intra-hospital mortality
The intra-hospital mortality will be assessed after discharge

Full Information

First Posted
January 29, 2020
Last Updated
June 18, 2020
Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
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1. Study Identification

Unique Protocol Identification Number
NCT04259723
Brief Title
Virtual Reality Assisted Conscious Sedation During TAVI
Acronym
TAVI_VR
Official Title
Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Aortic Valve Stenosis, Anxiety, Pain
Keywords
TAVI, VR, 3D glasses

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
VR during TAVI
Intervention Description
Virtual Reality (VR) glasses
Primary Outcome Measure Information:
Title
Change in anxiety
Description
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)
Time Frame
at Baseline
Title
Change in anxiety
Description
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)
Time Frame
after 24 hours
Secondary Outcome Measure Information:
Title
Time of VR
Description
The time [min] of VR use will be recorded during the procedure
Time Frame
at Baseline
Title
Evaluation of clinical frailty scale
Description
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).
Time Frame
at Baseline
Title
Measurement of pain: visual analog scale
Description
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)
Time Frame
after 24 hours
Title
Length of stay at hospital
Description
The length of stay at hospital will be recorded.
Time Frame
up to 5 days
Title
Occurence of vomitting
Description
Patients will be asked during and after the procedure for safety problems with special regards to vomiting
Time Frame
at Baseline, periprocedural and after 24 hours
Title
Occurence of nausea
Description
Patients will be asked during and after the procedure for safety problems with special regards to nausea
Time Frame
at Baseline, periprocedural and after 24 hours
Title
Rate of Intra-hospital mortality
Description
The intra-hospital mortality will be assessed after discharge
Time Frame
up to 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Division of Cardiology, Pulmonary Disease and Vascular Medicine
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Virtual Reality Assisted Conscious Sedation During TAVI

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