Relaxation Music to Lower Heart Rate Prior to Cardiac CT

Not Applicable

Completed

• Conditions: Patients Undergoing CT Calcium Score; Patients Undergoing CT Pulmonary Vein Angiogram; Coronary Artery Disease and Cardiac Anatomy; Patients Undergoing Coronary CT Angiogram
• Interventions: Other: Relaxation Music

• Registration Number: NCT02069405
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-24
• Primary Completion: 2014-05
• Study Completion: 2014-11
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Group plus normal standard of care	Relaxation Music	Patients will listen to music prior and during the scan

Primary Outcome Measures

Name	Time	Method
Change in Heart Rate	Same day as CT scan	Unit of measure - beats per minute

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Health Network, Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada