Relaxation Music to Lower Heart Rate Prior to Cardiac CT

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02069405
First received: December 11, 2013
Last updated: February 24, 2014
Last verified: December 2013

December 11, 2013
February 24, 2014
December 2013
April 2014   (final data collection date for primary outcome measure)
Change in Heart Rate [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
Unit of measure - beats per minute
Change in Heart Rate [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02069405 on ClinicalTrials.gov Archive Site
  • Radiation Dose [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
    Unit of measure - millisieverts
  • Image Quality [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
    Measurement tool - Likert Scale. Review of images by two highly experienced cardiac radiologists
  • IV metoprolol dose [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
    Unit of measurement - milligrams
  • Patient Satisfaction [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
    Measuerment tool - Modified state-trait anxiety inventory (STAI) questionnaire
  • Radiation Dose [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
  • Image Quality [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
  • IV metoprolol dose [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: Same day as CT scan ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Relaxation Music to Lower Heart Rate Prior to Cardiac CT
Relaxation Music to Lower Heart Rate Prior to Cardiac CT

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • 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
  • Experimental: Music Group plus normal standard of care
    Patients will listen to music prior and during the scan
    Intervention: Other: Relaxation Music
  • No Intervention: Control Group - Normal standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ming-Yen Ng, BMBS 416-340-4800 ext 8122 ming-yen.ng@uhn.ca
Contact: Yasser Karimzad, HBSc 416-946-4501 ext 3516 yasser.karimzad@uhn.ca
Canada
 
NCT02069405
13-6798-AE
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
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
University Health Network, Toronto
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP