Clinical trial NCT03076801: Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?
Official title: Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Coronary Heart Disease
Myocardial Infarction
Keywords: Choral Singing
Music
Quality of Life
Psychosocial Stress
Cardiac Rehabilitation
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2017-03-10
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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?".

Eligibility 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.

Primary outcomes:
measure: Psychosocial Stress
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Rate of hospitalization.
timeFrame: 12 months
measure: Rates of death.
timeFrame: 12 months
measure: Rates of myocardial infarction .
timeFrame: 12 months
measure: Rates of stroke.
timeFrame: 12 months
measure: Intervention adherence
timeFrame: 3 months
Other outcomes:
measure: Qualitative Feedback
timeFrame: 3 months
Locations:
city: Sydney
country: Canada
facility: Heart and Lung Wellness Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Paul MacDonald, MD
role: PRINCIPAL_INVESTIGATOR
References: