Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076801
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Dalhousie University
Information provided by (Responsible Party):
Paul MacDonald, Nova Scotia Health Authority

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Coronary Heart Disease Myocardial Infarction Behavioral: Choral Singing Not Applicable

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?".


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The investigator will be blind to participant allocation during chart review at 12 months.
Primary Purpose: Prevention
Official Title: Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?: A Pilot Randomized Controlled Trial
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : October 5, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rate of hospitalization. [ Time Frame: 12 months ]
    Rates of hospitalization over 12 months will be determined by chart review.

  2. Rates of death. [ Time Frame: 12 months ]
    Rates of death over 12 months will be determined by chart review.

  3. Rates of myocardial infarction . [ Time Frame: 12 months ]
    Rates of myocardial infarction over 12 months will be determined by chart review.

  4. Rates of stroke. [ Time Frame: 12 months ]
    Rates of stroke over 12 months will be determined by chart review.

  5. Intervention adherence [ Time Frame: 3 months ]
    Weekly attendance will be taken for participants in the intervention arm.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076801


Locations
Layout table for location information
Canada, Nova Scotia
Heart and Lung Wellness Centre
Sydney, Nova Scotia, Canada, B1S 0H5
Sponsors and Collaborators
Nova Scotia Health Authority
Dalhousie University
Investigators
Layout table for investigator information
Principal Investigator: Paul MacDonald, MD Nova Scotia Health Authority

Layout table for additonal information
Responsible Party: Paul MacDonald, Dr. Paul MacDonald, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03076801     History of Changes
Other Study ID Numbers: 1019989
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul MacDonald, Nova Scotia Health Authority:
Choral Singing
Music
Quality of Life
Psychosocial Stress
Cardiac Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Infarction
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases