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临床试验/NCT05939505
NCT05939505Unknown不适用

The Effect of Sujok Therapy on Symptom Burden and Comfort Level in Patients Undergoing Hemodialysis Treatment

Candan DOGAN0 个研究点目标入组 140 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
140
主要终点
Symptom burden in hemodialysis patients

研究概览

简要总结

Many symptoms such as fatigue, muscle cramps, dry mouth, and headache that develop in patients due to the hemodialysis treatment process affect the quality of life and comfort of people. Sujok therapy is an effective method in symptom management. Although sujok therapy is an uncomplicated acupressure, it has positive features such as being uncomplicated so that it can be applied by the patients themselves.

This study is planned as a single-blind placebo-controlled randomized trial. Research Hypotheses H0/1: Hydrotherapy has no effect on symptom burden in hemodialysis patients. H0/2: Hydrotherapy has no effect on hemodialysis comfort in hemodialysis patients.

H1/1: Hydrotherapy has an effect on symptom burden in hemodialysis patients. H1/2: Hydrotherapy has an effect on hemodialysis comfort in hemodialysis patients.

Inclusion criteria of volunteers

  1. 18 years or older
  2. To be on HD treatment for at least 6 months In our study, there are three groups as experimental, placebo and control groups.

Group application steps to be applied water jok therapy(experimental groups); The right foot in men and the left foot in women will be preferred, and the outer and inner surface of the foot will be massaged with a massage stick for an average of 3 minutes, then the middle of the area between the 3rd and 4th toes and the wrist line on the outer surface of the foot, which represents the kidney area in the macro system. The pain point will be determined with a diagnostic metal rod in the thoracic 12th spine and the area representing the lumbar 3rd spine region, and it will be fixed with the help of a Mexican bean seed patch in the appropriate size for the painful spot, and it will be ensured to remain in the area for at least 8 hours.

Group administration steps to be administered placebo ( Placebo Groups); It is planned that all the application steps will be the same as the group in which water jok therapy was applied, but instead of Mexican bean seeds, the use of red plastic number bean, which is used to improve the counting skill, is planned.

Control group application steps; It is planned to implement routine interventions applied in dialysis centers.

Sujok therapy and placebo application will be applied by the researcher during each dialysis session and it is planned to be carried out in a way to complete 14 sessions.

In the study, it is planned to use Dialysis Symptom Index together with Hemodialysis Comfort Scale Version Ⅱ for the groups before the application, after the seventh and fourteenth application.

详细描述

The purpose of hemodialysis treatment; to remove metabolic wastes from the blood, to reduce symptoms and complications in patients, and to increase life expectancy and quality. During the hemodialysis treatment process, many comorbidities, complications and symptoms may occur in patients(1). The number of symptoms and the high load of effects in patients negatively affect their quality of life. In addition, life expectancy decreases and mortality rates increase in these patients (2). In order to reduce the burden of symptoms accompanying HD and increase the quality of life, it is necessary to ensure HD sufficiency and maintain physical, mental and biochemical well-being Su Jok therapy is defined as a modern interpretation of acupressure/acupuncture that can be applied to both acute and chronic diseases for symptom improvement and health promotion by using reflection points on the hands and feet(3). According to the Su Jok theory; There is energy flow and circulation in the body, and in case of illness, this energy flow is disrupted in the organ or a part of the body. With Su Jok therapy, it is argued that as a result of the application of various applicators (rings, metal starlets, magnets, etc.) and appropriate plant seeds to the hands and feet, which the energy system considers as stimulating points, the physically sick organ or body area is stimulated. It is stated that as a result of this stimulation, the energy in the body is activated and an improvement in symptoms is observed (4). Su Jok therapy, with the absence of any interference to the body, ease of application and learning, allows patients to apply it on their own with good counseling, and symptom management is also very effective. It is stated that nurses can apply Su Jok therapy as an integrative method in symptom management due to the simple and uncomplicated nature of Su Jok therapy and the need for invasive procedures (5).

Details of Study Design and Method This study is planned as a single-blind placebo-controlled randomized trial. The number of samples to be reached with patients who meet the criteria for inclusion in the study is planned to be the group in which sujok therapy was applied (37 people), the group that was administered placebo (37 people) and the control group (37 people) in which routine applications were made.

The researcher attended the Sujok Therapy Training given by the International Sujok Association between 08-28.11.2022. The content of the training consists of theoretical and practical information including the history of Su Jok, its mechanism of action, areas of use, basic information about Su Jok points.

Group application steps to be applied water jok therapy; The right foot in men and the left foot in women will be preferred, and the outer and inner surface of the foot will be massaged with a massage stick for an average of 3 minutes, then the middle of the area between the 3rd and 4th toes and the wrist line on the outer surface of the foot, which represents the kidney area in the macro system. The pain point will be determined with a diagnostic metal rod in the thoracic 12th spine and the area representing the lumbar 3rd spine region, and it will be fixed with the help of a Mexican bean seed patch in the appropriate size for the painful spot, and it will be ensured to remain in the area for at least 8 hours. It also plans insect (micro system) work simultaneously with the macro system, and the pain point is detected with a diagnostic metal rod in the lower 2/3 part of the 3rd node (the area representing the kidney region in the insect system) on the outer surface of the toes, and the appropriate size for the painful point is located in Mexico. bean seed will be fixed with the help of a plaster and it will be ensured that it remains in the area for at least 8 hours.

Group administration steps to be administered placebo; It is planned that all the application steps will be the same as the group in which water jok therapy was applied, but instead of Mexican bean seeds, the use of red plastic number bean, which is used to improve the counting skill, is planned.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not know which group they are in. The person who analyzes the data obtained at the end of the study will not know the groups.

入排标准

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

入选标准

  • be 18 years or older
  • Receiving hemodialysis treatment for at least 6 months
  • agreeing to participate in the study

排除标准

  • Having food, metal and plastic allergies
  • Having a cognitive and psychiatric diagnosis
  • Loss of sensation and amputation that prevents application in the feet

结局指标

主要结局

Symptom burden in hemodialysis patients

时间窗: pre-therapy, up to 3 weeks, up to 5 weeks

Dialysis Symptom Index

次要结局

  • hemodialysis comfort in hemodialysis patients(pre-therapy, up to 3 weeks, up to 5 weeks)

研究者

发起方
Candan DOGAN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Candan DOGAN

Instructor

Tokat Gaziosmanpasa University

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