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

Tracking Information
First Submitted Date ICMJE	June 17, 2012
First Posted Date ICMJE	July 3, 2012
Last Update Posted Date	October 29, 2013
Study Start Date ICMJE	June 2012
Actual Primary Completion Date	November 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 28, 2012)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01632670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 28, 2012)	Stress and anxiety questionnaire [ Time Frame: 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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy
Official Title ICMJE	FEAT: Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Coronary Artery Disease; Endothelial Dysfunction
Intervention ICMJE	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.
Study Arms	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. Intervention: Other: Music therapy; No Intervention: No music therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: June 28, 2012)	70
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	November 2012
Actual Primary Completion Date	November 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Age >18 years; Referred for clinically-indicated cardiac catheterization Exclusion Criteria: Refusal or inability to provide signed informed consent; Significant hearing loss
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01632670
Other Study ID Numbers ICMJE	12-027
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Emmanouil Brilakis, North Texas Veterans Healthcare System
Study Sponsor ICMJE	Emmanouil Brilakis
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
PRS Account	North Texas Veterans Healthcare System
Verification Date	October 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP