The Effect of Foot Bath on Comfort, Fatigue, and Dialysis Symptoms

NCT ID: NCT05759169

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-10-01

Brief Summary

This study aimed to evaluate the effect of warm water foot baths on comfort, fatigue, and dialysis symptoms in patients undergoing hemodialysis.

This study was conducted as a randomized controlled trial. Data were collected with a total of 58 patients,31 in the intervention group and 27 in the placebo group. The data in the study is collected using the intervention and control group informed volunteer Form, Patient Demonstration Form, foot Bath Application Monitoring Chart, fatigue VAS Scale Form, dialysis Symptom Index, and Hemodialysis Comfort Scale.

Detailed Description

After obtaining the necessary permissions for the work to be performed, the researcher explained the purpose of working, and the researcher took the purpose of the work. The voluntary consent of the individuals was provided in verbal and written writing.

The researcher discussed the health team in dialysis centers to ensure that the study was carried out systematically and regularly, providing information on the purpose of the study. The forms to be applied to patients are filled by the researcher using the method of a face-to-face interview and the records obtained from the patient files.

Procedures administered to control groups:

Patients in the control group have been informed about the voluntary Form, Patient Demonstration Form, fatigue VAS Scale Form, dialysis Symptom Index, and Hemodialysis Comfort Scale performed by the researcher in person. At this stage, no attempt was made to the control group at the end of the fourth week; during the last hemodialysis session, the researcher, with the fatigue VAS Scale Form, the dialysis Symptom Index and the Hemodialysis Comfort Scale face-to-face, treated the patients.

Procedures administered to intervention groups:

In line with the literature and expert opinions, each dialysis application has been applied to individuals for 30 minutes for the first 30 minutes of 4 weeks, with a 40-43°C hot water-filled foot wash tub, placing both feet of the individual (Afrasiabifar et al., 2022; Kim et al., 2021 Shafeik et al., 2018). The researcher implemented the voluntary consent Form, Patient Demonstration Form, foot Bath Application Monitoring Chart, fatigue VAS Scale Form, dialysis Symptom Index and Hemodialysis Comfort Scale in person. At the end of the fourth week, the researcher refilled the foot Bath Application Monitoring Chart, the fatigue VAS Scale Form, the dialysis Symptom Index, and the Hemodialysis Comfort Scale. A total of 12 sessions have been performed in the foot bath, including during each dialysis treatment for 4 weeks.

Conditions

Comfort; Fatigue; Symptoms and Signs

Study Design

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

Study Groups

Intervention

In line with the literature and expert opinions, each dialysis application has been applied to individuals for 30 minutes for the first 30 minutes of 4 weeks, with a 40-43°C hot water-filled foot wash tub, placing both feet of the individual (Afrasiabifar et al., 2022; Kim et al., 2021 Shafeik et al., 2018). The researcher implemented the voluntary consent Form, Patient Demonstration Form, foot Bath Application Monitoring Chart, fatigue VAS Scale Form, dialysis Symptom Index and Hemodialysis Comfort Scale in person. At the end of the fourth week, the researcher refilled the foot Bath Application Monitoring Chart, the fatigue VAS Scale Form, the dialysis Symptom Index, and the Hemodialysis Comfort Scale. A total of 12 sessions have been performed in the foot bath, including during each dialysis treatment for 4 weeks.

Group Type: EXPERIMENTAL

Foot Bath Tub

Intervention Type: OTHER

A foot bath is generally a form of rest and care where feet are put in water. Feet are body areas where fatigue is most felt as organs that carry the body's total weight. This study uses a specially designed foot bath bath bath bath to give the patients in the experimental group foot bath. The cuvette has four-stage water heating (35-45°C). It has a magnetic field and operates at 390 Watts. It has a splash guard. The sole features non-slip rubber feet. It has a heat shield feature because it has a double wall construction for heat isolation.

Control

Patients in the control group have been informed about the voluntary Form, Patient Demonstration Form, fatigue VAS Scale Form, dialysis Symptom Index, and Hemodialysis Comfort Scale performed by the researcher in person. At this stage, no attempt was made to the control group at the end of the fourth week; during the last hemodialysis session, the researcher, with the fatigue VAS Scale Form, the dialysis Symptom Index and the Hemodialysis Comfort Scale face-to-face, treated the patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Foot Bath Tub

A foot bath is generally a form of rest and care where feet are put in water. Feet are body areas where fatigue is most felt as organs that carry the body's total weight. This study uses a specially designed foot bath bath bath bath to give the patients in the experimental group foot bath. The cuvette has four-stage water heating (35-45°C). It has a magnetic field and operates at 390 Watts. It has a splash guard. The sole features non-slip rubber feet. It has a heat shield feature because it has a double wall construction for heat isolation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Over 18 years old,
• For patients over 65 years of age, the standardized Mini-mental Test (SMMT) value is 24 points or higher,
• Without pregnancy,
• With at least 6 months in HD units and 3 sessions per week,
• Continuing dialysis treatment in the same institution,
• No change in the foot bath treatment process and during the research process,
• Individuals who understand and communicate in Turkish have been investigated

Exclusion Criteria

• Any psychiatric illness,
• Patients with neurovascular complications, advanced diabetes Mellitus,
• Patients with disease and treatment that trigger fatigue (advanced COPD, cancer, chemotherapy, and radiotherapy patients),
• With open wounds, neuropathy, etc., lower leg problems, which will prevent hot water treatment,
• Patients with peripheral vascular diseases in feet and legs,
• Also, patients with sensory deficits and foot ulcers,
• Patients using any complementary and integral treatment method during research,
• Patients with a standardized Mini-mental Test (SMMT) value of 23 points and less than 65 years old have been excluded from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Sevil Şahin

Assoc Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sevil Güler

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021/4587

Identifier Type: -

Identifier Source: org_study_id