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

Tracking Information

First Received Date ^ICMJE

June 17, 2012

Last Updated Date

October 27, 2013

Start Date ^ICMJE

June 2012

Primary Completion Date

November 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01632670 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease
Endothelial Dysfunction

Intervention ^ICMJE

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.

Study Arms

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

November 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age >18 years
Referred for clinically-indicated cardiac catheterization

Exclusion Criteria:

Refusal or inability to provide signed informed consent
Significant hearing loss

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01632670

Other Study ID Numbers ^ICMJE

12-027

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Emmanouil Brilakis, North Texas Veterans Healthcare System

Study Sponsor ^ICMJE

Emmanouil Brilakis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Emmanouil S Brilakis, MD, PhD

North Texas Veterans Healthcare System

PRS Account

North Texas Veterans Healthcare System

Verification Date

October 2013

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

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