Clinical trial NCT05759169: The Effect of Foot Bath on Comfort, Fatigue, and Dialysis Symptoms
Official title: The Effect of Foot Bath Applied to Patients Receiving Hemodialysis Treatment on Comfort, Fatigue, and Dialysis Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comfort
Fatigue
Symptoms and Signs
Keywords: comfort
fatigue,
foot bath
hemodialysis
nursing
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study was done in a randomized controlled experimental research pattern to determine the effect of the foot bath applied in the last 30 minutes of dialysis treatment on comfort, fatigue and dialysis symptoms for hemodialysis patients.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Fatigue VAS Scale Form
timeFrame: One mounth. Fatigue levels are at the end of the process and 4 before the application begins. During the last hemodialysis session of the week, fatigue was evaluated by the VAS Scale Form.
measure: Dialysis Symptom Index
timeFrame: One mounth. In the first week of the trial and 4 weeks later
measure: Hemodialysis Comfort Scale
timeFrame: One mounth. In the first week of the trial and 4 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Sevil Güler
Study officials:
References: