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OpenTrials
Completed

NCT Number: NCT04259723

Virtual Reality Assisted Conscious Sedation During TAVI

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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Key information

Conditions

Severe Aortic Valve Stenosis Anxiety Anxiety Disorders Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VR during TAVI

Other

Virtual Reality (VR) glasses

Primary outcomes

  1. Change in anxiety

    Time frame: at Baseline

    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)

  2. Change in anxiety

    Time frame: 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 outcomes

  1. Time of VR

    Time frame: at Baseline

    The time [min] of VR use will be recorded during the procedure

  2. Evaluation of clinical frailty scale

    Time frame: 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).

  3. Measurement of pain: visual analog scale

    Time frame: 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)

  4. Length of stay at hospital

    Time frame: up to 5 days

    The length of stay at hospital will be recorded.

  5. Occurence of vomitting

    Time frame: at Baseline, periprocedural and after 24 hours

    Patients will be asked during and after the procedure for safety problems with special regards to vomiting

  6. Occurence of nausea

    Time frame: at Baseline, periprocedural and after 24 hours

    Patients will be asked during and after the procedure for safety problems with special regards to nausea

  7. Rate of Intra-hospital mortality

    Time frame: up to 5 days

    The intra-hospital mortality will be assessed after discharge

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Official study title

Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study

Acronym: TAVI_VR

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2020
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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