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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
June 17, 2012
July 3, 2012
October 29, 2013
June 2012
November 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01632670 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy
FEAT: 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Endothelial Dysfunction
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.
  • 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.
    Intervention: Other: Music therapy
  • No Intervention: No music therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
November 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01632670
12-027
No
Not Provided
Not Provided
Emmanouil Brilakis, North Texas Veterans Healthcare System
Emmanouil Brilakis
Not Provided
Principal Investigator: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
North Texas Veterans Healthcare System
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP