Randomized Controlled Trial of Classical Massage and Benson Relaxation Exercise for Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in symptom status
研究概览
简要总结
Patients with heart failure will be entered. Participants will be randomized to one of three study arms: Arm 1: Classical massage, Arm 2: Relaxation, Arm 3: Control Hypothesis: Classical Massage and Benson Muscle Relaxation will decrease frequency, severity, discomfort of symptoms and improve quality of life.
详细描述
Previous reports have revealed that classical massage and Benson relaxation exercise are promising for physiological parameters such as respiratory rate, pulse, blood pressure in heart failure patients. On the other hand, research examining effects of these approaches on physical symptom status that is including dyspnea, orthopnea, fatigue, chest pain, peripheral edema, sleep problems and dizziness and quality of life is limited. The present study investigates the effects of classical massage and Benson relaxation exercise in a single-site, 3-arm, randomized, controlled study of 96 patients with heart failure. Arm 1: Classical massage; Arm 2: Benson relaxation exercise; Arm 3: Control. The investigators hypothesize that Classical Massage and Benson relaxation exercise will decrease frequency, severity, discomfort of symptoms and improve quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being at least primary school graduates,
- •Being over 18 years old
- •Being diagnosed Stage III-IV with heart failure
- •Not using any other complementary or integrative therapy during the study period
排除标准
- •Having an additional disease such as advanced stage chronic obstructive pulmonary disease, asthma, cancer
- •Stage I-II diagnosed with heart failure
- •Having an active thrombosis
- •Having a coagulation problem
- •Not volunteering to participate in the research
- •Patients who have been hospitalized for 5 days or less and discharged before five days after the start of the application.
结局指标
主要结局
Change in symptom status
时间窗: Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions
Symptom status will be measured based on patient report by the Symptom Status Questionnaire-Heart Failure . Higher score means increase in symptom burden.
Change in quality of life
时间窗: Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions
Quality of live will be measured by the Minnesota Living with Heart Failure Questionnaire. Higher scores on the scale mean worse quality of life.
次要结局
未报告次要终点
研究者
Merve Gulbahar
Research Assistant
Hacettepe University