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临床试验/NCT05759169
NCT05759169已完成不适用

The Effect of Foot Bath Applied to Patients Receiving Hemodialysis Treatment on Comfort, Fatigue, and Dialysis Symptoms

TC Erciyes University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Fatigue VAS Scale Form

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

No masking done

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Fatigue VAS Scale Form

时间窗: 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.

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.

Dialysis Symptom Index

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

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.

Hemodialysis Comfort Scale

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

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevil Şahin

Assoc Prof Dr

TC Erciyes University

研究点 (2)

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