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

NCT05759169 | Completed DMC

• 1 other identifier: 2021/4587
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Comfort; Fatigue; Symptoms and Signs

Keywords

comfort; fatigue,; foot bath; hemodialysis; nursing

Outcome Measures

Primary Outcomes (3)

• Fatigue VAS Scale Form

  The rating of fatigue levels has been expressed to patients that there is no fatigue for 0 points. In comparison, 10 points indicate fatigue is very severe and are questioned how many points they have given to patients for fatigue levels.

  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.

• Dialysis Symptom Index

  DSI contains 30 symptoms that define a specific physical or emotional symptom. Symptoms in the last seven days have been answered as yes-no, and no indicates no symptoms, and yes, that symptom has occurred. If the patient's response is yes, how much the symptom affects is evaluated by a five-type Likert scale. 1 = none, 5 = too many ratings are made. Total scale points are collected. This value varies between 0 and 150. The total scores received show an increase in the effect of the symptom mentioned as approaching 150.

  One mounth. In the first week of the trial and 4 weeks later

• Hemodialysis Comfort Scale

  Falcon Orak and Ark. Hemodialysis Comfort Scale (HCS), developed in 2017, with validity reliability, is a reliable scale used to assess the comfort of patients who have had hemodialysis treatment for at least six months. The hemodialysis Comfort Scale is a five-type liquid scale and consists of 9 substances and 2 sub-dimensions. T HCS can score at least 9.00 points and up to 45.00 points; 3.00 points can be achieved at least 15.00 points maximum, relax Alt-size; at least 7.00 points and up to 30.00 points can be obtained from the bottom dimension that is defeated. The increase in the value obtained indicates the level of comfort.

  One mounth. In the first week of the trial and 4 weeks later

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Foot Bath Tub

Control

NO INTERVENTION

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.

Interventions

Foot Bath Tub 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Sevil Güler

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue; Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking done
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Dr

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: March 8, 2023
• Study Start: May 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)