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

NCT03076801 | Completed

• 1 other identifier: 1019989
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Coronary Heart Disease; Myocardial Infarction

Keywords

Choral Singing; Music; Quality of Life; Psychosocial Stress; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of hospitalization.

  12 months

• Rates of death.

  12 months

• Rates of myocardial infarction .

  12 months

• Rates of stroke.

  12 months

• Intervention adherence

  3 months

Other Outcomes (1)

• Qualitative Feedback

  3 months

Study Arms (2)

Choral Singing Intervention

EXPERIMENTAL

In addition to usual medical care, participants in the intervention group will participate in choral singing.

Behavioral: Choral Singing

Control

NO INTERVENTION

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.

Interventions

Choral Singing BEHAVIORAL

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.

Choral Singing Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator

Study Sites (1)

Heart and Lung Wellness Centre

Sydney, Nova Scotia, B1S 0H5, Canada

Location

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Paul MacDonald, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator will be blind to participant allocation during chart review at 12 months.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Paul MacDonald

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 10, 2017
• Study Start: September 25, 2017
• Primary Completion: July 26, 2018
• Study Completion: October 5, 2018
• Last Updated: November 26, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)