Virtual Reality Assisted Conscious Sedation During TAVI

NCT04259723 | Completed

• 1 other identifier: 19-007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Aortic Valve Stenosis; Anxiety; Pain

Keywords

TAVI; VR; 3D glasses

Outcome Measures

Primary Outcomes (2)

• 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)

  at Baseline

• 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)

  after 24 hours

Secondary Outcomes (7)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Other: VR during TAVI

Control

NO INTERVENTION

Interventions

VR during TAVI OTHER

Virtual Reality (VR) glasses

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Interventional transfemoral TAVI
• Informed consent
• Normal or corrected vision (through glasses)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Klinik für Kardiologie, Pneumologie und Angiologie: lead

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 6, 2020
• Study Start: November 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

DE (1)