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

NCT06613087 | Completed

• 1 other identifier: Naz-682
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Failure; Pain

Keywords

foot bath; insomnia; fatigue

Outcome Measures

Primary Outcomes (3)

• Numerical Rating Scale

  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

  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

  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

Study Arms (2)

Foot bath

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Foot bath OTHER

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.

Foot bath

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

AmasyaU

Amasya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency; Pain; Sleep Initiation and Maintenance Disorders; Fatigue

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: September 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 23, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

TU (1)