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临床试验/NCT05892679
NCT05892679已完成不适用

The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study

Mersin University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年5月30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
60
试验地点
2
主要终点
Fatigue to be evaluated using the Piper Fatigue Scale

研究概览

简要总结

This randomized controlled study evaluates the effect of acupressure application on fatigue, quality of life and comfort in hemodialysis patients. In our research, it is aimed to reduce fatigue, increase the quality of life and comfort level in hemodialysis patients with acupressure applied.

详细描述

In the study, 60 hemodialysis patients were randomly assigned to the study and control groups. The study group (n=30) Acupressure is formulated according to the standards of the World Health Organization and in a certain order to the points of Stomach 36 (St 36), Gall Bladder 34 point (GB 34), Spleen 6 point (SP 6) and Kidney 1 point (K 1) will be applied. Consideration will be given to the appropriate pressure intensity and duration. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. Considering the anatomical area where the point is located, the most suitable thumb, index and/or middle finger will be used for application to the relevant point. Successive compressions will be applied at a frequency that does not disturb the patient, does not cause pain, and has a calming effect. Considering the studies done, a person will be given acupressure three times a week for four weeks. No intervention will be made to the control group (n=30). In order to avoid ethical problems both groups will be given an informative training on acupressure and fatigue, increase the quality of life and comfort level in hemodialysis patients at the end of the study. The primary outcome of the study is the effect of acupuncture on fatigue in hemodialysis patients. The secondary result of the study is the effect of acupuncture on quality of life and comfort level in hemodialysis patients.

The results will be collected before the acupressure and in the 4th week of the last intervention.

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

The researcher cannot be blinded due to the nature of the research. However, participants will be blinded without knowing whether they are in the study group or the placebo group. Thus, the research will be carried out as a single-blind randomized controlled trial. When the research is completed, the data of the study and control groups (coded as A or B) will be transferred to the computer environment by an independent researcher, and the data will be analyzed by a statistician and the findings will be reported.

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

  • Written and verbal consent was obtained to participate in the study,
  • Can read, write, speak and understand Turkish,
  • Are older than 18 years,
  • Have received HD treatment for at least 6 months,
  • Receiving HD treatment 3 times a week,
  • Fatigue severity ≥4, using a single-item fatigue index ranging from 0 to 10 points,
  • Absence of lower extremity wounds
  • Any complementary therapy
  • Conscious, fully oriented and cooperative and open to communication,
  • No visual, hearing and perception problems,
  • Any psychiatric patient

排除标准

  • Wound or amputation of lower extremities, rheumatoid arthritis or limb fracture
  • Any psychiatric disease,
  • Patients with hepatitis B and hepatitis C,
  • Using any of the complementary and integrated methods
  • Those who receive HD treatment twice a week

结局指标

主要结局

Fatigue to be evaluated using the Piper Fatigue Scale

时间窗: Change from before implementation and 4th week of practice

The total score obtained from the scale varies between 0 and 10 and as the score increases, the fatigue experienced by the individuals increases.

次要结局

  • Life Quality to be evaluated using Kidney Disease and Quality of Life Short Form (KDQOL-SF 1.3)(Change from before implementation and 4th week of practice)
  • Comfort to be evaluated using Hemodialysis Comfort Scale(Change from before implementation and 4th week of practice)

研究者

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

VECİHE DÜZEL GÜNDÜZ

MSN Nurse

Mersin University

研究点 (2)

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