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

NCT ID: NCT06287996

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-23
• Study Completion Date: 2024-08-01

Brief 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.

Detailed 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.

Conditions

Footbath; Heart Failure; Sleep Quality; Fatigue; Heart Rate Variability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Warm water foot-bath and actigraphy

Warm water foot-bath and actigraphy

Group Type: EXPERIMENTAL

footbath and actigraphy

Intervention Type: OTHER

Receive warm water foot bath for 4 weeks, 1 hour before going to bed every night (7-9PM), temperature 42℃ for 20 minutes, water depth 10cm above the ankle joint and wearing an actigraphy for 4 weeks

actigraphy

Intervention Type: DEVICE

Wearing an actigraphy for 4 weeks

actigraphy

actigraphy

Group Type: ACTIVE_COMPARATOR

actigraphy

Intervention Type: DEVICE

Wearing an actigraphy for 4 weeks

Interventions

footbath and actigraphy

Receive warm water foot bath for 4 weeks, 1 hour before going to bed every night (7-9PM), temperature 42℃ for 20 minutes, water depth 10cm above the ankle joint and wearing an actigraphy for 4 weeks

Intervention Type: OTHER

actigraphy

Wearing an actigraphy for 4 weeks

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mackay Memorial Hospital

Taipei, Zhongshan, Taiwan

Countries

Taiwan

Other Identifiers

23MMHIS503e NA

Identifier Type: -

Identifier Source: org_study_id