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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632670
First Posted: July 3, 2012
Last Update Posted: October 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease Endothelial Dysfunction Other: Music therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FEAT: Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy

Further study details as provided by Emmanouil Brilakis, North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 70
Study Start Date: June 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Music therapy
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.
Other: Music therapy
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.
No Intervention: No music therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years
  2. Referred for clinically-indicated cardiac catheterization

Exclusion Criteria:

  1. Refusal or inability to provide signed informed consent
  2. Significant hearing loss
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632670


Locations
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Emmanouil Brilakis
Investigators
Principal Investigator: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
  More Information

Responsible Party: Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01632670     History of Changes
Other Study ID Numbers: 12-027
First Submitted: June 17, 2012
First Posted: July 3, 2012
Last Update Posted: October 29, 2013
Last Verified: October 2013

Keywords provided by Emmanouil Brilakis, North Texas Veterans Healthcare System:
music
cardiac catheterization
endothelial function

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases