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

NCT01632670 | Completed Phase 4

• 1 other identifier: 12-027
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Endothelial Dysfunction

Keywords

music; cardiac catheterization; endothelial function

Outcome Measures

Primary Outcomes (1)

• change in reactive hyperemia index measured by peripheral arterial tonometry

  PAT will be performed within 2 hours before cardiac catheterizaiton and repeated within 2 hours after the end of cardiac catheterization

Secondary Outcomes (1)

• Stress and anxiety questionnaire

  questionnaire will be completed within 2 hours after the end of cardiac catheterization

Study Arms (2)

Music therapy

EXPERIMENTAL

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

No music therapy

NO INTERVENTION

Interventions

Music therapy OTHER

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.

Music therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Referred for clinically-indicated cardiac catheterization

You may not qualify if:

• Refusal or inability to provide signed informed consent
• Significant hearing loss

Sponsors & Collaborators

• Emmanouil Brilakis: lead

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Emmanouil S Brilakis, MD, PhD

  North Texas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cardiac Catheterization Laboratories

Study Record Dates

• First Submitted: June 17, 2012
• First Posted: July 3, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

US (1)