Back to resultsFunctional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy (FEAT)
Primary Purpose
Coronary Artery Disease, Endothelial Dysfunction
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Music therapy
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring music, cardiac catheterization, endothelial function
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Referred for clinically-indicated cardiac catheterization
Exclusion Criteria:
- Refusal or inability to provide signed informed consent
- Significant hearing loss
Sites / Locations
- Dallas VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music therapy
No music therapy
Arm 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.
Outcomes
Primary Outcome Measures
change in reactive hyperemia index measured by peripheral arterial tonometry
Secondary Outcome Measures
Stress and anxiety questionnaire
a stess and anxiety questionnaire will be completed within 2 hours after cardiac catheterization is completed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01632670
Brief Title
Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy
Acronym
FEAT
Official Title
FEAT: Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emmanouil Brilakis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Endothelial Dysfunction
Keywords
music, cardiac catheterization, endothelial function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music therapy
Arm Type
Experimental
Arm 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.
Arm Title
No music therapy
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Music therapy
Intervention 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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Stress and anxiety questionnaire
Description
a stess and anxiety questionnaire will be completed within 2 hours after cardiac catheterization is completed
Time Frame
questionnaire will be completed within 2 hours after the end of cardiac catheterization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years
Referred for clinically-indicated cardiac catheterization
Exclusion Criteria:
Refusal or inability to provide signed informed consent
Significant hearing loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanouil S Brilakis, MD, PhD
Organizational Affiliation
North Texas Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy
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