Renal FailureFoot BathNCT06613087
Effect of Foot Bath on the Severity of Pain, Fatigue and Insomnia in Patients With Acute Renal Failure
A study testing Foot bath in people with Renal Failure and Pain, run by Amasya University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure, Pain
- What is being tested?
- Foot bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 23 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Renal Failure, Pain
- Being tested
- Foot bath
- Keywords
- foot bath, insomnia, fatigue
- Medical subject headings
- Renal Insufficiency, Pain, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot bathOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Sep 2024
- Primary completion31 May 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naz Fısgın, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613087
- Sponsor's protocol ID
- Naz-682
- Acronym
- Foot Bath
- Status last verified
- Jun 2025
- First submitted
- 23 Sep 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Bath on the Severity of Pain, Fatigue and Insomnia in Patients With Acute Renal Failure
- ClinicalTrials.gov ID
- NCT06613087
- Acronym / sponsor ID
- Foot Bath / Naz-682
- Conditions
- Renal Failure, Pain
- Keywords
- foot bath, insomnia, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foot bath | Experimental | Other: Foot bathIn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot bathIn 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 |
Primary outcome
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot bath in people with Renal Failure and Pain, run by Amasya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: 5 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.