Foot Bath Effects on Chemotherapy-Induced Fatigue in Pediatric Oncology

NCT ID: NCT06529484

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-08-30

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.

Conditions

Nursing Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental Group

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.

Group Type: EXPERIMENTAL

Warm Water Foot Bath Intervention

Intervention Type: OTHER

Participants will take a warm water foot bath at 38-40ºC for 20 minutes nightly for 7 days.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Warm Water Foot Bath Intervention

Participants will take a warm water foot bath at 38-40ºC for 20 minutes nightly for 7 days.

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Koç University

OTHER

Sponsor Role: lead

Responsible Party

Özge Eda Karadağ Aytemiz

Assistant Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Özge Eda Karadağ Aytemiz

Role: PRINCIPAL_INVESTIGATOR

Koç University

Central Contacts

Özge Eda Karadağ Aytemiz

Role: CONTACT

ozgedak@gmail.com

05520289066

Other Identifiers

E-22686390-050.99-46591

Identifier Type: -

Identifier Source: org_study_id