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临床试验/NCT05466045
NCT05466045Unknown不适用

Using of Extra Virgin Olive Oil in Patient With Hemodialysis to Improve the Effect of Pruritus and Sleep Disorders

National Taipei University of Nursing and Health Sciences0 个研究点目标入组 86 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
86
主要终点
Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve

研究概览

简要总结

Background and Purpose:

Itching is a common complication of hemodialysis patients, which can cause skin damage and affect the patient's comfort. Studies have shown that olive oil is feasible and effective for pain relief, cancer treatment, stroke and cardiovascular disease, as well as wound healing and skin care because it is readily available, natural, and has merely no side effects, and there is no research application on the skin itchiness in hemodialysis patients. The purpose of this study was to investigate the effect of applying extra virgin olive oil to improve skin itching, sleep quality and changes in heart rate variability in hemodialysis patients.

Research method:

This study is designed as a randomized controlled trial (RCT), which is divided into two groups, the experimental group and the control group. Before the interventional measures, a questionnaire pre-test and HRV test are given first, and the interventional measures are given. During the period, in addition to routine care, both groups of patients used a brown roller ball glass bottle containing extra virgin olive oil or normal saline on the itchy skin every 12 hours gently and evenly smeared with fingers , for 28 days, and on the 14th day and 28 days.After intervention, the post-questionnaire test and HRV test were carried out. The research tools include: 5-D 5-D itch scale, Visual Analogue Scale (VAS), Pittsburgh Sleep Quality Index (PSQI) and Heart Rate Variability (HRV) detector.The data collection results were archived with Statistical Package for the Social Sciences (SPSS) statistical software, and the data were processed and analyzed by descriptive statistics, chi-square test, generalized estimating equation (GEE) and independent sample t test.

Expected results: Result showed using extra virgin olive oil can improvement of skin itchiness and sleep quality in hemodialysis patients, and also cost effectiveness of lotions , reduction of drugs burden on kidneys and improvement of patients' quality of life.

详细描述

Background and Purpose:

Itching is a common complication of hemodialysis patients, which can cause skin damage and affect the patient's comfort. It will not only affect social activities, but also affect the quality of life. In severe cases, it will cause sleep disorders. Studies have shown that olive oil is feasible and effective for pain relief, cancer treatment, stroke and cardiovascular disease, as well as wound healing and skin care because it is readily available, natural, and has no side effects, and there is no research application on the skin itchiness in hemodialysis patients.Therefore the purpose of this study was to investigate the effect of applying extra virgin olive oil to improve skin itching, sleep quality and changes in heart rate variability in hemodialysis patients.

Research method:

This study is designed as a randomized controlled trial (RCT), which is divided into two groups, the experimental group and the control group. The research process is divided into three stages. Before the interventional measures, a questionnaire pre-test and HRV test are given first.The interventional measures are given. During the period, in addition to routine care, both groups of patients used a brown roller ball glass bottle containing extra virgin olive oil or normal saline on the itchy skin every 12 hours gently and evenly smeared with fingers for 28 days. Questionnaire and HRV test were carried on the 14th day .After intervention, the post-questionnaire test and HRV test were carried out. The research tools include: 5-D 5-D itch scale, Visual Analogue Scale (VAS), Pittsburgh Sleep Quality Index (PSQI) and Heart Rate Variability (HRV) detector.The data collection results were archived with Statistical Package for the Social Sciences (SPSS) statistical software, and the data were processed and analyzed by descriptive statistics, chi-square test, generalized estimating equation (GEE) and independent sample t test.

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
Single (Participant)

入排标准

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

入选标准

  • ESRD ,Regular hemodialysis patients >3 months

排除标准

  • allergic patients
  • skin infection
  • atopic dermatitis

结局指标

主要结局

Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve

时间窗: the 1th ,14th, 28th day

change of Sleep quality

Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus

时间窗: the 1th ,14th, 28th day

change of Pruritus

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

Mei-Hua, Pan

Principal Investigator

National Taipei University of Nursing and Health Sciences

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