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CompletedNCT06613087Foot BathUpdated Jun 29, 2025

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

An interventional study of Foot bath in Renal Failure and Pain, sponsored by Amasya University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by Amasya University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Failure
  • Pain

Keywords

  • foot bath
  • insomnia
  • fatigue
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 50 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Amasya University is the lead sponsor of 78 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherFoot 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 day

  2. 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.

    Time frame: 5 day

  3. 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).

    Time frame: 5 day

07

Study locations

1 site
  • AmasyaU
    Amasya, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06613087
Lead sponsor
Amasya University
Responsible party
Naz Fısgın (Director, Amasya University) — Principal investigator
First posted
Sep 25, 2024
Start date
Sep 1, 2024
Primary completion
May 31, 2025
Completion
Jun 23, 2025
Last update
Jun 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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