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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01632670
Acronym
FEAT
Enrollment
70
Registered
2012-07-03
Start date
2012-06-30
Completion date
2012-11-30
Last updated
2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Endothelial Dysfunction

Keywords

music, cardiac catheterization, endothelial function

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.

Interventions

OTHERMusic 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.

Sponsors

Emmanouil Brilakis
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
change in reactive hyperemia index measured by peripheral arterial tonometryPAT will be performed within 2 hours before cardiac catheterizaiton and repeated within 2 hours after the end of cardiac catheterization

Secondary

MeasureTime frameDescription
Stress and anxiety questionnairequestionnaire will be completed within 2 hours after the end of cardiac catheterizationa stess and anxiety questionnaire will be completed within 2 hours after cardiac catheterization is completed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026