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Effects of Foot Bath on Chemotherapy Complications

Evaluation and Comparison of the Effects of Foot Bath with Cold and Warm Saline on Fatigue, Neuropathy, Self-Efficacy, and Quality of Life in Cancer Patients Undergoing Chemotherapy in Shahroud: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250913067225N1
Enrollment
120
Registered
2025-09-21
Start date
2025-09-23
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer. Malignant neoplasms of ill-defined, secondary and unspecified sites

Interventions

Intervention 1: Intervention group: In the intervention group, participants are asked to use a salt-water bath every other day for two weeks. The warm salt water is set at 41°C, and patients are instr

Sponsors

Shahroud University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: A CIPN questionnaire score of =40, age range 18 to 60 years, presence of at least 6 symptoms of A and disorder B according to the ICD-10 scale, ability to understand and speak Persian, ability to receive phone calls during the study, awareness of their illness for at least three weeks prior to sampling, receiving at least three planned cycles of chemotherapy, no history of loss of consciousness or dementia, no history of psychiatric disorders, use of psychoactive drugs, or recent psychotherapy, no severe anemia (defined as hemoglobin level <9 g/dL), no malnutrition (BMI <18 kg/m²), definite diagnosis of cancer by a specialist physician, no skin reactions that would prevent a salt-water bath, no musculoskeletal limitations in the limbs, and patients whose interval between two chemotherapy sessions is more than two weeks.

Exclusion criteria

Exclusion criteria: Simultaneous participation in similar studies, use of psychoactive drugs and psychotherapy prescribed by a physician during the study, not performing more than one session of foot bathing, skin reaction to salt water, discontinuation or interruption of treatment, unwillingness to continue participation, migration, or death during the study.

Design outcomes

Primary

MeasureTime frame
Cancer-related fatigue is a subjective, intense experience disproportionate to normal fatigue, encompassing physical and cognitive dimensions. It is one of the most common and distressing symptoms among cancer patients, especially during chemotherapy and radiotherapy, and can affect personal resources, nutritional status, and treatment outcomes. Timepoint: before and after. Method of measurement: Cancer Fatigue Scale (CFS) by Okuyama et al. (2000) was used to assess participants’ fatigue. The scale has 15 items across three dimensions: physical, emotional, and cognitive, rated on a 5-point Likert scale (0 = not at all, 4 = very much). Total scores range from 0 to 60, and reliability has been reported with a Cronbach’s alpha of 0.88.;Self-efficacy refers to an individual’s confidence in their ability to perform behaviors and self-care tasks, and higher self-efficacy can reduce symptom distress and improve quality of life in cancer patients. Timepoint: before and after. Method of measurement: In this study, self-efficacy was assessed using the Chronic Disease Self-Efficacy Scale (CDSES) by Kim et al. (2012). The scale has 33 items across three dimensions: self-efficacy in managing self-behaviors, general self-efficacy, and self-efficacy in achieving desired outcomes. Scores range from 1 (not confident at all) to 10 (completely confident), with higher scores indicating greater self-efficacy. Reliability of the total scale was reported with a Cronbach’s alpha of 0.93.;Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of chemotherapy, primarily presenting with sensory symptoms such as tingling, numbness, and pain in the hands and feet, which can be chronic or delayed in some patients. Timepoint: before and after. Method of measurement: In this study, CIPN was assessed using the 20-item questionnaire by Smith et al. (2013), comprising three subscales for sensory, motor, and autonomic symptoms. Responses are rated on a four-point Likert scale, with

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Rahmani Iniolia

Shahroud University of Medical Sciences

zahra.rahmani.iniolia@gmail.com+98 910 191 4903

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026