MedDataX Logo

Relaxation Music to Lower Heart Rate Prior to Cardiac CT

NCT ID: NCT02069405

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease and Cardiac Anatomy Patients Undergoing Coronary CT Angiogram Patients Undergoing CT Pulmonary Vein Angiogram Patients Undergoing CT Calcium Score

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Music Group plus normal standard of care

Patients will listen to music prior and during the scan

Group Type EXPERIMENTAL

Relaxation Music

Intervention Type OTHER

Control Group - Normal standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Relaxation Music

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elsie Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Joint Department of Medical Imaging

Ming-Yen Ng, BMBS

Role: STUDY_CHAIR

University Health Network, Joint Department of Medical Imaging

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-6798-AE

Identifier Type: -

Identifier Source: org_study_id