Nursing CariesFBECIFPONCT06529484
Foot Bath Effects on Chemotherapy-Induced Fatigue in Pediatric Oncology
A study testing Warm Water Foot Bath Intervention in people with Nursing Caries, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of foot baths on chemotherapy-induced fatigue in pediatric oncology patients. Current literature lacks studies assessing this intervention in the pediatric population. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Warm Water Foot Bath Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 30 Aug 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents' consent to participate in the study and provide written informed consent.
- No diagnosed chronic illness other than cancer.
- Parents are literate in Turkish.
- Children aged between 7-12 years.
- Diagnosis of Stage 3 or 4 Non-Hodgkin Lymphoma.
- Receiving the first course of chemotherapy.
- Fatigue level of 3 or higher according to the Visual Fatigue Scale by the Oncology Nursing Society of America.
Who cannot join
- Children with cancer who have mental retardation and their parents.
- Children with cancer who have undergone surgical operations that hinder activities or result in significant organ loss, and their parents.
- Children with compromised skin integrity.
- Children with cancer and their parents who do not wish to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa Hospital
Istanbul, Istanbul
About this study
Official title: Investigation of the Effects of Foot Bath on Chemotherapy-Induced Fatigue in Pediatric Oncology Patients: A Randomized Controlled Trial
This study aims to evaluate the effects of foot baths on chemotherapy-induced fatigue in pediatric oncology patients. Current literature lacks studies assessing this intervention in the pediatric population. Chemotherapy, a common cancer treatment, often results in side effects such as nausea, vomiting, constipation, diarrhea, taste changes, mouth ulcers, and notably, fatigue. Fatigue affects 51-86% of pediatric cancer patients and significantly impacts their quality of life. Addressing fatigue comprehensively is crucial for improving patients' quality of life. Non-pharmacological methods like foot baths have shown promise in reducing chemotherapy-related fatigue. Previous studies with gynecological cancer patients and others have found that warm water foot baths can alleviate fatigue and improve relaxation by reducing sympathetic activity and facilitating oxygen and nutrient delivery to the brain. This randomized controlled trial is designed to scientifically evaluate the efficacy of foot baths in alleviating fatigue in pediatric patients post-chemotherapy.
Read the detailed description
Study Objective: There are no existing studies in the literature that evaluate the effect of foot baths on chemotherapy-induced fatigue in the pediatric population. Therefore, this research aims to assess the impact of foot baths on fatigue in pediatric patients post-chemotherapy and scientifically examine this effect through a randomized controlled trial.
General Information: One of the commonly used treatment methods in coping with cancer is chemotherapy. Chemotherapy causes many side effects in patients, such as nausea and vomiting, constipation, diarrhea, changes in taste and smell, mouth ulcers, and notably, fatigue. Fatigue is frequently reported by patients. Literature indicates that 51-86% of children with cancer experience fatigue related to cancer and its treatment. Fatigue can negatively affect the quality of life of patients, making it an important area of focus in the care of children with cancer. Comprehensive management of fatigue is crucial for improving the patient's quality of life. One non-pharmacological method that can be used to reduce fatigue is a foot bath. In a study involving patients with gynecological cancer, soaking feet in warm water (41-42°C) for 20 minutes was found to be effective in reducing chemotherapy-related fatigue. Another study by Yamamoto and colleagues evaluating the physical and psychological effects of foot baths with warm water on cancer patients indicated that after a 5-minute massage with olive oil, soaking feet in water at 38-42°C for 20 minutes provided relaxation and pain relief by reducing sympathetic activity. Another study found that warm water foot baths facilitated the delivery of oxygen and nutrients to the brain by increasing blood volume through vasodilation, thus reducing fatigue.
- Conditions
- Nursing Caries
- Being tested
- Warm Water Foot Bath Intervention
- Keywords
- Nursing, child, footbath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Water Foot Bath InterventionOther
Participants will take a warm water foot bath at 38-40ºC for 20 minutes nightly for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will receive interactive training and an educational booklet on fatigue, its definition, causes, development, coping strategies, and water temperature adjustment. Each patient gets a marked plastic basin for 8 liters and a thermometer.
Starting the next day, patients will take a 38-40ºC warm water bath for 20 minutes between 21:00-22:00 nightly for 7 days to manage fatigue. This time ensures the child rests after the bath.
In the initial 30-minute meeting, evaluation tools will assess the patient's personal and disease-related characteristics, fatigue level on the treatment day, impact due to fatigue, and coping strategies. Patients will be called daily for 7 days to assess fatigue levels using the Scale. On the 7th day, the final interview will use the 12-Item Scale and the Parental Fatigue Scale for 7-12 Year old patients. Receives: Other: Warm Water Foot Bath Intervention |
| Control Group | No intervention | The control group will receive interactive training and an educational booklet covering the definition, causes, development, and effective coping strategies for chemotherapy-related fatigue. Patients in this group will be assessed between 21:00-22:00 in the evening, without the warm water foot bath intervention. The evaluations will focus on fatigue levels and other related outcomes over the 7-day period. On the 7th day, the final interview will use the 12-Item Pediatric Oncology Fatigue Scale and the Parental Fatigue Scale for 7-12 Year Old Pediatric Oncology Patients, concluding the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Fatigue Scale Points
The scale is designed to assess fatigue in pediatric oncology patients aged 7-12 years, as reported by their parents. It comprises 27 items and three subscales, with a total Cronbach's alpha value of 0.95, indicating high internal consistency. The subscales are as follows: General Problems: This subscale assesses general fatigue in pediatric oncology patients and includes items from the first and 18th questions. Sleep Problems: This subscale focuses on sleep-related issues stemming from fatigue, including items from the 19th to the 24th questions. Treatment-Related Problems: This subscale evaluates the impact of treatment on fatigue, covering items from the 25th to the 27th questions. The scale uses a Likert-type format, where responses are rated from "1" to "5," with "1" indicating "never" and "5" indicating "always." The total score ranges from a minimum of 27 to a maximum of 135 points. An increase in the scale score suggests a decrease in the child's level of fatigue.
Measured: measured daily over a period of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start15 Oct 2024
- Primary completion30 Apr 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Eda Karadağ Aytemiz, Koç University
- Investigators
- Özge Eda Karadağ Aytemiz, Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529484
- Sponsor's protocol ID
- E-22686390-050.99-46591
- Acronym
- FBECIFPO
- Status last verified
- Feb 2026
- First submitted
- 26 Jul 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Foot Bath on Chemotherapy-Induced Fatigue in Pediatric Oncology Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06529484
- Acronym / sponsor ID
- FBECIFPO / E-22686390-050.99-46591
- Conditions
- Nursing Caries
- Keywords
- Nursing, child, footbath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 31 Jul 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.
This study aims to evaluate the effects of foot baths on chemotherapy-induced fatigue in pediatric oncology patients. Current literature lacks studies assessing this intervention in the pediatric population. Chemotherapy, a common cancer treatment, often results in side effects such as nausea, vomiting, constipation, diarrhea, taste changes, mouth ulcers, and notably, fatigue. Fatigue affects 51-86% of pediatric cancer patients and significantly impacts their quality of life. Addressing fatigue comprehensively is crucial for improving patients' quality of life. Non-pharmacological methods like foot baths have shown promise in reducing chemotherapy-related fatigue. Previous studies with gynecological cancer patients and others have found that warm water foot baths can alleviate fatigue and improve relaxation by reducing sympathetic activity and facilitating oxygen and nutrient delivery to the brain. This randomized controlled trial is designed to scientifically evaluate the efficacy of foot baths in alleviating fatigue in pediatric patients post-chemotherapy.
Detailed description
Study Objective: There are no existing studies in the literature that evaluate the effect of foot baths on chemotherapy-induced fatigue in the pediatric population. Therefore, this research aims to assess the impact of foot baths on fatigue in pediatric patients post-chemotherapy and scientifically examine this effect through a randomized controlled trial.
General Information: One of the commonly used treatment methods in coping with cancer is chemotherapy. Chemotherapy causes many side effects in patients, such as nausea and vomiting, constipation, diarrhea, changes in taste and smell, mouth ulcers, and notably, fatigue. Fatigue is frequently reported by patients. Literature indicates that 51-86% of children with cancer experience fatigue related to cancer and its treatment. Fatigue can negatively affect the quality of life of patients, making it an important area of focus in the care of children with cancer. Comprehensive management of fatigue is crucial for improving the patient's quality of life. One non-pharmacological method that can be used to reduce fatigue is a foot bath. In a study involving patients with gynecological cancer, soaking feet in warm water (41-42°C) for 20 minutes was found to be effective in reducing chemotherapy-related fatigue. Another study by Yamamoto and colleagues evaluating the physical and psychological effects of foot baths with warm water on cancer patients indicated that after a 5-minute massage with olive oil, soaking feet in water at 38-42°C for 20 minutes provided relaxation and pain relief by reducing sympathetic activity. Another study found that warm water foot baths facilitated the delivery of oxygen and nutrients to the brain by increasing blood volume through vasodilation, thus reducing fatigue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Warm Water Foot Bath InterventionThe experimental group will receive interactive training and an educational booklet on fatigue, its definition, causes, development, coping strategies, and water temperature adjustment. Each patient gets a marked plastic basin for 8 liters and a thermometer. Starting the next day, patients will take a 38-40ºC warm water bath for 20 minutes between 21:00-22:00 nightly for 7 days to manage fatigue. This time ensures the child rests after the bath. In the initial 30-minute meeting, evaluation tools will assess the patient's personal and disease-related characteristics, fatigue level on the treatment day, impact due to fatigue, and coping strategies. Patients will be called daily for 7 days to assess fatigue levels using the Scale. On the 7th day, the final interview will use the 12-Item Scale and the Parental Fatigue Scale for 7-12 Year old patients. |
| Control Group | No intervention | –The control group will receive interactive training and an educational booklet covering the definition, causes, development, and effective coping strategies for chemotherapy-related fatigue. Patients in this group will be assessed between 21:00-22:00 in the evening, without the warm water foot bath intervention. The evaluations will focus on fatigue levels and other related outcomes over the 7-day period. On the 7th day, the final interview will use the 12-Item Pediatric Oncology Fatigue Scale and the Parental Fatigue Scale for 7-12 Year Old Pediatric Oncology Patients, concluding the study. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parents' consent to participate in the study and provide written informed consent.
- No diagnosed chronic illness other than cancer.
- Parents are literate in Turkish.
- Children aged between 7-12 years.
- Diagnosis of Stage 3 or 4 Non-Hodgkin Lymphoma.
Key exclusion criteria (4 listed)
- Children with cancer who have mental retardation and their parents.
- Children with cancer who have undergone surgical operations that hinder activities or result in significant organ loss, and their parents.
- Children with compromised skin integrity.
- Children with cancer and their parents who do not wish to participate in the study
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 |
|---|---|---|
| Warm Water Foot Bath InterventionParticipants will take a warm water foot bath at 38-40ºC for 20 minutes nightly for 7 days. | Other | Experimental Group |
Primary outcome
Parental Fatigue Scale Points
Time frame: measured daily over a period of 7 days.
The scale is designed to assess fatigue in pediatric oncology patients aged 7-12 years, as reported by their parents. It comprises 27 items and three subscales, with a total Cronbach's alpha value of 0.95, indicating high internal consistency. The subscales are as follows: General Problems: This subscale assesses general fatigue in pediatric oncology patients and includes items from the first and 18th questions. Sleep Problems: This subscale focuses on sleep-related issues stemming from fatigue, including items from the 19th to the 24th questions. Treatment-Related Problems: This subscale evaluates the impact of treatment on fatigue, covering items from the 25th to the 27th questions. The scale uses a Likert-type format, where responses are rated from "1" to "5," with "1" indicating "never" and "5" indicating "always." The total score ranges from a minimum of 27 to a maximum of 135 points. An increase in the scale score suggests a decrease in the child's level of fatigue.
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 10 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Özge Eda Karadağ Aytemiz principal investigator
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Water Foot Bath Intervention in people with Nursing Caries, run by Koç 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 7 inclusion and 4 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 10 Feb 2026. 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?
Parental Fatigue Scale Points (time frame: measured daily over a period of 7 days.). 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 10 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.