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OpenTrials
Completed

NCT Number: NCT01632670

Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy

The purpose of this study is to determine the effect of music therapy before, during, and after cardiac catheterization is associated on (a) change in reactive hyperemia index measured before and after catheterization using peripheral arterial tonometry and (b) patient stress and discomfort measured by a questionnaire, as compared to the standard of care (no music during cardiac catheterization).

The hypothesis of the study is that music therapy during cardiac catheterization will be associated with more favorable change in reactive hyperemia and higher patient satisfaction compared to no music playback.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 years
  • Referred for clinically-indicated cardiac catheterization

Exclusion criteria

  • Refusal or inability to provide signed informed consent
  • Significant hearing loss

Treatment and study plan

Music Therapy

Other

The music played will be by MusiCure, by Niels Eje (slow, relaxing music designed for therapeutic use), and will be played from an audio pillow beneath the patient's head.

Primary outcomes

  1. change in reactive hyperemia index measured by peripheral arterial tonometry

    Time frame: PAT will be performed within 2 hours before cardiac catheterizaiton and repeated within 2 hours after the end of cardiac catheterization

Secondary outcomes

  1. Stress and anxiety questionnaire

    Time frame: questionnaire will be completed within 2 hours after the end of cardiac catheterization

    a stess and anxiety questionnaire will be completed within 2 hours after cardiac catheterization is completed

Sponsors and collaborators

Lead sponsor

Emmanouil Brilakis

Fed

Registry information

Official study title

FEAT: Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy

Acronym: FEAT

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 3, 2012
Registry last updated
Oct 29, 2013

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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