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

Myocardial Infarction Clinical Trial

— CHOIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076801
• Other study ID #: 1019989
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: October 5, 2018

Study information

• Verified date: November 2018
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 5, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Infarction
• Ischemia
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Canada	Heart and Lung Wellness Centre	Sydney	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Dalhousie University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Feedback	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
Primary	Psychosocial Stress	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	Rate of hospitalization.	Rates of hospitalization over 12 months will be determined by chart review.	12 months
Secondary	Rates of death.	Rates of death over 12 months will be determined by chart review.	12 months
Secondary	Rates of myocardial infarction .	Rates of myocardial infarction over 12 months will be determined by chart review.	12 months
Secondary	Rates of stroke.	Rates of stroke over 12 months will be determined by chart review.	12 months
Secondary	Intervention adherence	Weekly attendance will be taken for participants in the intervention arm.	3 months