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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.	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

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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