Foot Bath Effects on Chemotherapy-Induced Fatigue in Pediatric Oncology

NCT06529484 | Completed

• 1 other identifier: E-22686390-050.99-46591
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nursing Caries

Keywords

Nursing, child, footbath

Outcome Measures

Primary Outcomes (1)

• 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 daily over a period of 7 days.

Study Arms (2)

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.

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.

Interventions

Warm Water Foot Bath Intervention OTHER

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

Experimental Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Istanbul University-Cerrahpasa Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

Study Officials

• Özge Eda Karadağ Aytemiz

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: October 15, 2024
• Primary Completion: April 30, 2025
• Study Completion: August 30, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

TU (1)