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Trial record 3 of 21 for:    Cardiac Catheterization | Open Studies | NIH, U.S. Fed
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Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy (FEAT)

This study is currently recruiting participants.
Verified June 2012 by North Texas Veterans Healthcare System
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01632670
First received: June 17, 2012
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Endothelial Dysfunction
 Other: Music therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FEAT: Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stress and anxiety questionnaire [ Time Frame: questionnaire will be completed within 2 hours after the end of cardiac catheterization ] [ Designated as safety issue: No ]
    a stess and anxiety questionnaire will be completed within 2 hours after cardiac catheterization is completed


Estimated Enrollment: 70
Study Start Date: June 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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.
No Intervention: No music therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632670

Locations
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Teresa D. Moore     214-857-0291     teresaD.Moore@va.gov    
Principal Investigator: Emmanouil S Brilakis, MD, PhD            
Sub-Investigator: Subhash Banerjee, MD            
Sponsors and Collaborators
Emmanouil Brilakis
Investigators
Principal Investigator: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
  More Information

No publications provided

Responsible Party: Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01632670     History of Changes
Other Study ID Numbers: 12-027
Study First Received: June 17, 2012
Last Updated: June 28, 2012
Health Authority: United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:
music
cardiac catheterization
endothelial function

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013