Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy (FEAT)
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ClinicalTrials.gov Identifier: NCT01632670 |
Recruitment Status
:
Completed
First Posted
: July 3, 2012
Last Update Posted
: October 29, 2013
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease Endothelial Dysfunction | Other: Music therapy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
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 |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |
Arm | Intervention/treatment |
---|---|
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.
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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.
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No Intervention: No music therapy |
- 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 ]
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18 years
- Referred for clinically-indicated cardiac catheterization
Exclusion Criteria:
- Refusal or inability to provide signed informed consent
- Significant hearing loss

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
United States, Texas | |
Dallas VA Medical Center | |
Dallas, Texas, United States, 75216 |
Principal Investigator: | Emmanouil S Brilakis, MD, PhD | North Texas Veterans Healthcare System |
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 Posted: | July 3, 2012 Key Record Dates |
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 |