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

Emmanouil Brilakis

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Endothelial Dysfunction

Treatments: Other: Music therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01632670

12-027

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Music therapy

Experimental group

Description:

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.

Treatment:

Other: Music therapy

No music therapy

No Intervention group