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Relaxation Music to Lower Heart Rate Prior to Cardiac CT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02069405
First Posted: February 24, 2014
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Health Network, Toronto
  Purpose
To acquire low radiation dose and good quality cardiac CT images requires scanning at low heart rates which is usually done with beta-blockers. However, in some patients beta-blockers have little effect. This is thought to be due to a different mechanism of action which continues to maintain the heart rate despite administration of beta-blockers. This study aims to look at the effect of music or relaxation tracks to reduce patient heart rate as anxiety is thought to play a role in maintaining high heart rates. This study will randomise patients into a normal standard of care group compared to a normal standard of care group with music/ relaxation track and compare heart rate, radiation dose, image quality, amount of beta-blocker used and patient experience via a State-Trait Anxiety Inventory (STAI) questionnaire.

Condition Intervention
Coronary Artery Disease and Cardiac Anatomy Patients Undergoing Coronary CT Angiogram Patients Undergoing CT Pulmonary Vein Angiogram Patients Undergoing CT Calcium Score Other: Relaxation Music

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Relaxation Music to Lower Heart Rate Prior to Cardiac CT

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Change in Heart Rate [ Time Frame: Same day as CT scan ]
    Unit of measure - beats per minute


Secondary Outcome Measures:
  • Radiation Dose [ Time Frame: Same day as CT scan ]
    Unit of measure - millisieverts

  • Image Quality [ Time Frame: Same day as CT scan ]
    Measurement tool - Likert Scale. Review of images by two highly experienced cardiac radiologists

  • IV metoprolol dose [ Time Frame: Same day as CT scan ]
    Unit of measurement - milligrams

  • Patient Satisfaction [ Time Frame: Same day as CT scan ]
    Measurement tool - Modified state-trait anxiety inventory (STAI) questionnaire


Enrollment: 197
Study Start Date: December 2013
Study Completion Date: November 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Music Group plus normal standard of care
Patients will listen to music prior and during the scan
Other: Relaxation Music
No Intervention: Control Group - Normal standard of care

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 years and above
  • All patients coming in for non-contrast enhanced calcium score CT, pulmonary vein angiogram, or coronary CT Angiogram

Exclusion Criteria:

  • Deaf
  • CT for Transcatheter aortic valve implantation (TAVI) or congenital heart disease patients
  • Poor english literacy
  • Pacemaker
  • Post CABG
  • Post heart transplant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069405


Locations
Canada, Ontario
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, m5g2c4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Elsie Nguyen, MD University Health Network, Joint Department of Medical Imaging
Study Chair: Ming-Yen Ng, BMBS University Health Network, Joint Department of Medical Imaging
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02069405     History of Changes
Other Study ID Numbers: 13-6798-AE
First Submitted: December 11, 2013
First Posted: February 24, 2014
Last Update Posted: December 8, 2014
Last Verified: December 2013

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