Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy (FEAT)
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ClinicalTrials.gov Identifier: NCT01632670 |
Recruitment Status
:
Completed
First Posted
: July 3, 2012
Last Update Posted
: October 29, 2013
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Tracking Information | ||||
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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 |
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 |
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
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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. |
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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 |
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Condition ICMJE |
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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. |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |