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

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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


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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age >18 years
Referred for clinically-indicated cardiac catheterization

Exclusion Criteria:

Refusal or inability to provide signed informed consent
Significant hearing loss

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


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
Study First Received:	June 17, 2012
Last Updated:	October 27, 2013
Health Authority:	United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:


music cardiac catheterization endothelial function

Additional relevant MeSH terms:


Coronary Artery Disease Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases	Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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