Viewing Study NCT06287996



Ignite Creation Date: 2024-05-06 @ 8:11 PM
Last Modification Date: 2024-10-26 @ 3:22 PM
Study NCT ID: NCT06287996
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-03-01
First Post: 2024-02-24

Brief Title: Effects of Warm Water Footbath Intervention on Sleep Quality Fatigue and Heart Rate Variability in Patients With Heart Failure
Sponsor: Mackay Memorial Hospital
Organization: Mackay Memorial Hospital

Study Overview

Official Title: Chief Nursing Officer Nursing Department Mackay Memorial Hospital
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 42C 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 260 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 homeWe hope it will be helpful to clinical care practice education and research

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None