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临床试验/NCT06287996
NCT06287996Enrolling By Invitation不适用

Chief Nursing Officer, Nursing Department, Mackay Memorial Hospital

Mackay Memorial Hospital2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
76
试验地点
2
主要终点
sleep quality

研究概览

简要总结

This study adopted an experimental research design to explore the effects of a warm water foot bath program on fatigue, sleep, and heart rate variability in patients with heart failure. The subjects of the study were heart failure patients in the cardiology outpatient department. The patients were randomly assigned to the experimental group and the control group. The control group received routine care and wore an actigraph. The experimental group received 4 additional care in addition to routine care and wearing an actigraph. Weekly warm water foot bath, data collection includes subjective sleep quality and fatigue level, physiological measurements: sleep quality-sleep time and efficiency, and heart rate variability index.

详细描述

This study adopted an experimental research design to explore the effects of a warm water foot bath program on fatigue, sleep, and heart rate variability in patients with heart failure. The research subjects are cardiology outpatients at two medical centers in northern China (Taipei and New Taipei City). It is expected to recruit 76 research subjects (38 in the control group and 38 in the experimental group). Pre-test data collection includes basic personal information, subjective sleep quality and fatigue level questionnaires, and wearing an actigraph on the wrist. Patients were assigned to an experimental group and a control group based on random assignment results. The control group received routine care and wore an actigraph. In addition to routine care and wearing an actigraph, the experimental group also received warm foot baths for 4 weeks, one hour before going to bed every night. (7-9PM), the temperature is 42°C for 20 minutes, and the water depth is 10 cm above the ankle joint. Both groups receive weekly phone calls to confirm wearing the actigraph and performing warm water foot baths. Post-test data were collected in the second and fourth weeks, including subjective sleep quality and fatigue level questionnaires. After the four weeks, the researchers collected and analyzed physiological measurements: sleep quality-sleep time and efficiency, and heart rate variability index. Research tools include basic information sheets, actigraphy, warm water foot bath machines, Pittsburgh Sleep Quality Scale, and Piper Fatigue Scale. The collected data were processed and analyzed using SPSS 26.0 statistical software. Warm water foot bath is a local hot compress, which is non-invasive and simple to operate. It has the effect of relieving sleep and fatigue of patients with heart failure. It is suitable for patients with heart failure during hospitalization or at home.We hope it will be helpful to clinical care practice, education and research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Diagnosed by a cardiologist as suffering from heart failure, NYHA functional class one to three and with a history of reduced ejection fraction (HFrEF, EF ≤ 40%)
  • Clear consciousness and able to communicate
  • Those who can maintain a sitting position by themselves or with the help of others
  • Temperature, hearing and vision are normal

排除标准

  • Leg injury or foot wound
  • Peripheral vascular disease
  • History of stroke

研究组 & 干预措施

Warm water foot-bath and actigraphy

Experimental

Warm water foot-bath and actigraphy

干预措施: footbath and actigraphy (Other)

Warm water foot-bath and actigraphy

Experimental

Warm water foot-bath and actigraphy

干预措施: actigraphy (Device)

actigraphy

Active Comparator

actigraphy

干预措施: actigraphy (Device)

结局指标

主要结局

sleep quality

时间窗: Before intervention and the 2nd and 4th week after intervention

次要结局

  • fatigue(Before intervention and the 2nd and 4th week after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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