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

Coronary Artery Disease Clinical Trial

— FEAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632670
• Other study ID #: 12-027
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2012
• Last updated: October 27, 2013
• Start date: June 2012
• Est. completion date: November 2012

Study information

• Verified date: October 2013
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Endothelial Dysfunction
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Dallas VA Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Emmanouil Brilakis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in reactive hyperemia index measured by peripheral arterial tonometry		PAT will be performed within 2 hours before cardiac catheterizaiton and repeated within 2 hours after the end of cardiac catheterization	No
Secondary	Stress and anxiety questionnaire	a stess and anxiety questionnaire will be completed within 2 hours after cardiac catheterization is completed	questionnaire will be completed within 2 hours after the end of cardiac catheterization	No