Effect of Foot Bath on the Severity of Pain, Fatigue and Insomnia in Patients With Acute Renal Failure (Foot Bath)

June 25, 2025 updated by: Naz Fısgın, Amasya University
One of the non-pharmacological methods that is easily applied, tolerated by the patient, and has no significant side effects is the foot bath. The aim of this study is to determine the effect of a foot bath applied to patients with acute renal failure on the severity of pain, fatigue, and insomnia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: One of the non-pharmacological methods that is easily applied, tolerated by the patient, and has no significant side effects is the foot bath.

Objective: The aim of this study is to determine the effect of a foot bath applied to patients with acute renal failure on the severity of pain, fatigue, and insomnia.

Method: The sample of this study will consist of 54 individuals who meet the inclusion criteria among patients with acute renal failure hospitalized in the internal medicine department of a training and research hospital in Amasya. The research data will be collected using a personal information form, numerical pain scale, fatigue severity scale, and insomnia severity index.

Conclusion: In diseases such as acute renal failure that develop suddenly and require hospitalization, it is important to use and evaluate the effectiveness of simple, applicable non-pharmacological methods in order to quickly control the symptoms of patients and ensure their comfort. The study results will contribute to the literature in this field.

Study Type

Interventional

Enrollment (Actual)

50

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 Locations

  • Turkey
      • Amasya, Turkey
        • AmasyaU

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:

  • Those over the age of 18
  • Those hospitalized in the internal medicine clinic with a diagnosis of acute renal failure
  • Those who speak and understand Turkish
  • Those who consent to participate in the study

Exclusion Criteria:

  • Those with cognitive dysfunction
  • Those diagnosed with chronic renal failure
  • Those with wounds on their feet
  • Those whose vital signs are not within normal limits (fever, high blood pressure, bradycardia, tachycardia, etc.)
  • Those receiving hemodialysis treatment for acute renal failure
  • Those taking medication for insomnia
  • Those who did not consent to participate in the study

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Foot bath
In the foot bath application, the feet will be kept in water at a constant temperature of 38-40 °C for about 20 minutes. During this time, the water temperature will be checked with a thermometer at intervals. Foot bath applications will be performed for 3 days, on the 2nd, 3rd and 4th days of hospitalization.
Other: Foot bath
In the foot bath application, the feet will be kept in water at a constant temperature of 38-40 °C for about 20 minutes. During this time, the water temperature will be checked with a thermometer at intervals. Foot bath applications will be performed for 3 days, on the 2nd, 3rd and 4th days of hospitalization.
No Intervention: Control
The control group will receive standard care. No intervention will be applied to these patients during the follow-up period, only data collection forms will be applied. Data collection forms will be collected in the same time period as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale
Time Frame: 5 day
The numerical pain scale was developed to assess the severity of pain. In this scale, the severity of the patient's pain is described with numerical values. Using numerical scales, pain severity is assessed by starting with "0" and grading up to "10". "0" indicates no pain, and "10" indicates unbearable pain. For the scale, the patient is asked to express the level of pain they feel at that moment with a number. The number expressed by the patient is accepted as the severity of the pain felt at that moment.
5 day
Fatigue Severity Scale
Time Frame: 5 day
Fatigue Severity Scale (FSS): FSS is a scale consisting of nine items that evaluate the general effect of fatigue on daily activities. In the scale, individuals are asked to rate the fatigue they have felt throughout the past week from 1 to 7. Each section is scored between 1 (I completely disagree) and 7 (I completely agree). The total score is calculated by taking the average of the nine items. The cut-off value for pathological fatigue is determined as 4 and above. The lower the total score, the less fatigue there is.
5 day
Insomnia Severity Index
Time Frame: 5 day
Insomnia Severity Index: Developed to determine the degree of insomnia symptoms, this can be used in the clinical evaluation of insomnia. It is a five-point Likert-type scale consisting of seven items. Each item is scored between 0 and 4, and the total score varies between 0-28. A score between 0-7 on the scale indicates clinically insignificant insomnia, 8-14 indicates the lower threshold of insomnia, 15-21 indicates clinical insomnia (moderate severity), and 22-28 indicates clinical insomnia (severe).
5 day

Collaborators and Investigators

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

Sponsor

Amasya 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 (Actual)

September 1, 2024

Primary Completion (Actual)

May 31, 2025

Study Completion (Actual)

June 23, 2025

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Naz-682

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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