Relaxation Music to Lower Heart Rate Prior to Cardiac CT

December 5, 2014 updated by: University Health Network, Toronto
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2C4
        • University Health Network, Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate
Time Frame: Same day as CT scan
Unit of measure - beats per minute
Same day as CT scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Dose
Time Frame: Same day as CT scan
Unit of measure - millisieverts
Same day as CT scan
Image Quality
Time Frame: Same day as CT scan
Measurement tool - Likert Scale. Review of images by two highly experienced cardiac radiologists
Same day as CT scan
IV metoprolol dose
Time Frame: Same day as CT scan
Unit of measurement - milligrams
Same day as CT scan
Patient Satisfaction
Time Frame: Same day as CT scan
Measurement tool - Modified state-trait anxiety inventory (STAI) questionnaire
Same day as CT scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-6798-AE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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