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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01632670
First received: June 17, 2012
Last updated: October 27, 2013
Last verified: October 2013
History of Changes

June 17, 2012
October 27, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
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