Clinical trial NCT06529484: Foot Bath Effects on Chemotherapy-Induced Fatigue in Pediatric Oncology
Official title: Investigation of the Effects of Foot Bath on Chemotherapy-Induced Fatigue in Pediatric Oncology Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nursing Caries
Keywords: Nursing, child, footbath
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Parental Fatigue Scale Points
timeFrame: measured daily over a period of 7 days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Koç University
name: Özge Eda Karadağ Aytemiz
role: PRINCIPAL_INVESTIGATOR
References: