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

Phase 4

Completed

• Conditions: Coronary Artery Disease; Endothelial Dysfunction
• Interventions: Other: Music therapy

• Registration Number: NCT01632670
• Lead Sponsor: Emmanouil Brilakis

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 available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-17
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-27
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music therapy	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Stress and anxiety questionnaire	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

Trial Locations

Locations (1)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States