Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Psychosocial Stress
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The investigator will be blind to participant allocation during chart review at 12 months.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Participants unable to respond to English questionnaires will be excluded.
研究组 & 干预措施
Choral Singing Intervention
In addition to usual medical care, participants in the intervention group will participate in choral singing.
干预措施: Choral Singing (Behavioral)
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.
结局指标
主要结局
Psychosocial Stress
时间窗: 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.
次要结局
- 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)
研究者
Paul MacDonald
Dr. Paul MacDonald
Nova Scotia Health Authority