Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? (CHOIR)

November 22, 2018 updated by: Paul MacDonald, Nova Scotia Health Authority

Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?: A Pilot Randomized Controlled Trial

This pilot randomized control trial will examine the role of choral singing on psychosocial stress and cardiovascular outcomes in patients with ischemic heart disease (IHD). The hypothesis is that choral singing will improve psychosocial stress in comparison to the control group and this may have an impact on rates of hospitalization, death, myocardial infarction and stroke in these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives:

The purpose of this pilot study is to examine the impact of choral singing on psychosocial stress and major cardiovascular events in patients with IHD in comparison to usual medical care.

Recruitment and Randomization:

Participants will be recruited from community cardiac rehabilitation programs with recruitment presentations, phone calls and mailed invitations. Interested participants will complete baseline questionnaires and provide consent. They will be randomly allocated to either the intervention or control group. Stratification by past or present experience in organized singing (as a binary variable, yes or no) will be used.

Baseline Assessment:

All participants will undergo a baseline assessment, comprised of biophysical characteristics and medical history; level of physical activity self reported by International Physical Activity Questionnaire (IPAQ) long form; assessment of music appreciation and current participation in group singing; and three questionnaires measuring psychosocial stress: the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS) and the Standard Form - 36 (SF - 36).

Intervention:

Participants in the intervention group will participate in weekly 60-90 minute singing sessions led by professional musicians over a 12-week period. Sessions will begin with a 5-minute physical warm-up of gentle stretching and a 5-minute vocal warm-up. Music will be selected from a variety of genres and eras. Attendance will be taken weekly.

Control:

The control group will receive usual medical care. If control group participants join a singing group during the study period they will not be excluded, but this data will be collected and considered.

Analysis:

Data analysis will be done blind with respect to participant allocation. Analysis will include and account for attendance or adherence to consider dose response. Only participants who have attended at least 50% of group singing sessions will be included. A sub-group comparison between those who have attended 50-74% of sessions and those who have attended ≥75% will be done to determine if there is a dose-response effect to the weekly singing sessions. Participants who join another singing group during or after the intervention period will not be excluded, but this will be taken into account. The concept of music "responders" and "non-responders" will be considered based on the initial screening question "How important is music in your day-to-day life?".

Study Type

Interventional

Enrollment (Actual)

16

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
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1S 0H5
        • Heart and Lung Wellness Centre

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must have a history of myocardial infarction or acute coronary syndrome and have undergone cardiac rehabilitation. All levels of musical ability and past experience will be included.

Exclusion Criteria:

  • Participants unable to respond to English questionnaires will be excluded.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Choral Singing Intervention
In addition to usual medical care, participants in the intervention group will participate in choral singing.
Behavioral: Choral Singing
In addition to usual medical care, participants in the intervention group will participate in weekly 60-90 minute singing sessions led by professional musicians over a 12-week period. Sessions will begin with a 5-minute physical warm-up of gentle stretching and a 5-minute vocal warm-up. Music will be selected from a variety of genres and eras. Attendance will be taken weekly.
No Intervention: Control
The control group will receive usual medical care only. If control group participants join an external singing group during the study period they will not be excluded, but this data will be collected and considered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosocial Stress
Time Frame: Baseline, 3 months and 6 months
Change in a composite measure of stress from baseline to 3 months and 6 months is the Primary Outcome Measure. This composite measure of stress is comprised of of the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS) and the Standard Form - 36 (SF - 36). Individual scores for the three scales will be determined for each participant at baseline, 3 and 6 months. These scores will be converted to the same scale and averaged with each component weighted equally to determine the composite stress score for each participant.
Baseline, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of hospitalization.
Time Frame: 12 months
Rates of hospitalization over 12 months will be determined by chart review.
12 months
Rates of death.
Time Frame: 12 months
Rates of death over 12 months will be determined by chart review.
12 months
Rates of myocardial infarction .
Time Frame: 12 months
Rates of myocardial infarction over 12 months will be determined by chart review.
12 months
Rates of stroke.
Time Frame: 12 months
Rates of stroke over 12 months will be determined by chart review.
12 months
Intervention adherence
Time Frame: 3 months
Weekly attendance will be taken for participants in the intervention arm.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Feedback
Time Frame: 3 months
As a tertiary outcome, informal, qualitative feedback about the music intervention from intervention participants and the musicians running the sessions will be collected.
3 months

Collaborators and Investigators

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

Sponsor

Nova Scotia Health Authority

Collaborators

Dalhousie University

Investigators

  • Principal Investigator: Paul MacDonald, MD, Nova Scotia Health Authority

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 (Actual)

September 25, 2017

Primary Completion (Actual)

July 26, 2018

Study Completion (Actual)

October 5, 2018

Study Registration Dates

First Submitted

February 24, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

November 26, 2018

Last Update Submitted That Met QC Criteria

November 22, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1019989

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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