Effects of Warm Water Footbath Intervention on Sleep Quality , Fatigue and Heart Rate Variability in Patients With Heart Failure

Heart Failure Clinical Trial

Official title: Chief Nursing Officer, Nursing Department, Mackay Memorial Hospital

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Fatigue
• Heart Failure
• Heart Rate Variability
• Sleep Quality

• NCT number: NCT06287996
• Study type: Interventional
• Source: Mackay Memorial Hospital
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 23, 2024
• Completion date: August 1, 2024