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

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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

Tracking Information
First Submitted Date  ICMJE February 24, 2017
First Posted Date  ICMJE March 10, 2017
Last Update Posted Date November 26, 2018
Actual Study Start Date  ICMJE September 25, 2017
Actual Primary Completion Date July 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)		 Psychosocial Stress [ Time Frame: 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.
Change History Complete list of historical versions of study NCT03076801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • Rate of hospitalization. [ Time Frame: 12 months ]
    Rates of hospitalization over 12 months will be determined by chart review.
  • Rates of death. [ Time Frame: 12 months ]
    Rates of death over 12 months will be determined by chart review.
  • Rates of myocardial infarction . [ Time Frame: 12 months ]
    Rates of myocardial infarction over 12 months will be determined by chart review.
  • Rates of stroke. [ Time Frame: 12 months ]
    Rates of stroke over 12 months will be determined by chart review.
  • Intervention adherence [ Time Frame: 3 months ]
    Weekly attendance will be taken for participants in the intervention arm.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 6, 2017)		 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?
Official Title  ICMJE Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?: A Pilot Randomized Controlled Trial
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?".
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Ischemic Heart Disease
  • Coronary Heart Disease
  • Myocardial Infarction
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Choral Singing Intervention
    In addition to usual medical care, participants in the intervention group will participate in choral singing.
    Intervention: Behavioral: Choral Singing
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2018)		 16
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2017)		 50
Actual Study Completion Date  ICMJE October 5, 2018
Actual Primary Completion Date July 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03076801
Other Study ID Numbers  ICMJE 1019989
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Paul MacDonald, Nova Scotia Health Authority
Study Sponsor  ICMJE Nova Scotia Health Authority
Collaborators  ICMJE Dalhousie University
Investigators  ICMJE
Principal Investigator: Paul MacDonald, MD Nova Scotia Health Authority
PRS Account Nova Scotia Health Authority
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP