The Effect of Hot Foot Bath on Sleep Quality and Fatigue

March 7, 2025 updated by: Dilek Yilmaz, PhD, Uludag University

Investigation of the Effect of Hot Foot Bath on Sleep Quality and Fatigue

This study will be conducted to investigate the effects of hot foot baths on patients' sleep quality and fatigue severity levels.The study will be conducted in the Gastroenterology clinic of a university hospital in Türkiye. The research sample will consist of 60 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application. No application will be applied to the control group, and sleep and fatigue levels will be measured in a similar manner to the measurement tools applied to the intervention group and the application days.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • being over the age of 18,
  • having no disorder which could affect pain perception,
  • having no communication problem, and voluntarily agreeing to participate in the research,
  • Having been admitted to the clinic at least 24 hours ago,
  • Not having a diagnosed sleep disorder,
  • Not having a psychiatric disorder requiring treatment,
  • Not having a problem with vital signs before the application,
  • Not using narcotic drugs in the last 4 hours,
  • Not eating two hours before going to bed at night

Exclusion Criteria:

  • being under the age of 18
  • not being conscious, refusing to participate in the research or opting to leave the study at any point,
  • Having a problem with vital signs before the application,
  • Having a diagnosed sleep disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Hot foot bath application group
Other: Hot foot bath application group
The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fatigue severity in score (0-10)
Time Frame: 4 months
Brief Fatigue Inventory: Scoring ranges from "0" to "10", with "0" indicating no effect and "10" indicating the highest level of effect. The general fatigue score is calculated by dividing the total score of items 1, 2 and 3 by 3, and the effect score of fatigue on daily living activities is calculated by dividing the total score of items 4a, 4b, 4c, 4d, 4e and 4f by 6. A score of "0" obtained from the KYE indicates no fatigue, "1-3" indicates low fatigue, "4-6" indicates moderate fatigue, "7-9" indicates high fatigue and "10" indicates the highest level of effe
4 months
Sleep Quality in score
Time Frame: 4 months
Sleep Quality Scale: It consists of a total of 18 items. It includes items related to the sleep process and sleep satisfaction.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: 4 months
weight in kilograms
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 5, 2025

Primary Completion (Estimated)

June 5, 2025

Study Completion (Estimated)

June 5, 2025

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-28/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B

Clinical Trials on Hot foot bath application group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe