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临床试验/NCT05002348
NCT05002348Unknown不适用

Construct and Apply Precision Care: An Informationized Model of Integrated Body Constitution of Chinese Medicine With Constipation Acupoints

Yueh-Lin Hsu2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12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
100
试验地点
2
主要终点
Explore the effect of acupoint stimulation on constipation in stroke patients.

研究概览

简要总结

With the aging of today's population, stroke is the top three causes of disability and death among people over the age of 60 in the world. About 5.5 million people die each year from strokes in Taiwan, and Taiwan's top ten causes of death in cerebrovascular disease rank fourth in the world. Constipation is the most common complication of stroke patients and increases the risk of brain damage and re-stroke. Although the clinical use of drugs can relieve intestinal symptoms, there is also a risk of potential side effects. The systematic literature points out that the use of acupoint stimulation can improve spontaneous bowel movements and promote bowel motility, but there is no conclusion on effective acupuncture points. Therefore, the purpose of this study is to improve the constipation of patients with stroke by non-invasive and precise acupoint care.

This study used a single-blind randomized control trial. The neurosurgery ward of a medical center in the north was used as the research site, and patients with ischemic stroke were used as the research objects. The experimental group received precision acupoint care, and the control group received routine care. The questionnaire was used to collect basic patient information (basic attributes, disease care and TCM constitution), and gut-related assessments. Data analysis was performed using IBM SPSS 22.0 software for descriptive statistical analysis and inferential statistical analysis, and p <.05 was considered to have statistical significance.

详细描述

Research purposes:

  1. Explore the effect of acupoint stimulation on constipation in stroke patients.
  2. Explore the effect of acupoint stimulation on bowel movement in patients with stroke.
  3. Explore the effect of acupoint stimulation on the quality of life of stroke patients.

Research methods:

  1. Selection criteria and number of people.

  2. Number of subjects accepted: 100 people in this hospital The sample number is estimated using G*power statistical software to estimate the number of samples to be collected. The two-tailed test, the α value is 0.05, the power is 0.8, the effect size is 0.25, and the estimated sample number is 86 people, each group is 43 people, considering the attrition rate of 20%, so the number of people in each group is 50, and the total number of people is 100.

  3. Conditions of inclusion:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Single-blind random assignment: When subjects are confirmed to have constipation, they will be given random coding groups with envelope bags after seeking their consent, and they will be divided into experimental and control groups, and the patient will not be told whether they belong to the experimental or the control group. During execution, the laser pen of the control group did not turn on the energy, and the laser pen of the experimental group turned on the energy. The acupoint stimulation was performed for about 3-5 minutes, and each acupoint was performed once a day.

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

  • Patients who are twenty years old and above, diagnosed with ischemic stroke combined with constipation.
  • A clear awareness and can communicate in national, Taiwanese, and Hakka languages.
  • The score on the National Institutes of Health Stroke Scale (NIHSS) developed by the National Institutes of Health is ≦
  • Patients who are willing to participate in this study and sign a consent form.

排除标准

  • Patients undergoing intravenous injection of thrombolytic agent combined tissue plasminogen activator (r-TPA), arterial thrombectomy (IA thrombectomy).
  • Imaging shows patients with brainstem stroke.
  • Patients who have installed cardiac rhythm devices or ventricular-abdominal shunt surgery.
  • Patients with abnormal coagulation function (with obvious spontaneous bleeding).
  • Patients with malignant tumors.
  • Patients with abnormal skin or obvious trauma at the location of acupuncture points.
  • There are patients who have undergone surgery on their abdomen.

结局指标

主要结局

Explore the effect of acupoint stimulation on constipation in stroke patients.

时间窗: 10 days

Use patient assessment of constipation symptom (PAC-SYM) with a minimum score of 0 and a maximum of 48. The higher the score, the more serious the constipation; the constipation asscessment scale (CAS), the minimum is 0 and the maximum is 16, the higher the score, the more severe the constipation; The Bristol Stool Scale is divided into types 1 to 7, the first type is severe constipation, and the seventh type is severe diarrhea. The score is evaluated every day to understand the subject's constipation.

次要结局

  • Explore the effect of acupoint stimulation on the quality of life of stroke patients.(10 days)
  • Explore the effect of acupoint stimulation on bowel movement in patients with stroke.(10 days)

研究者

发起方
Yueh-Lin Hsu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yueh-Lin Hsu

Nurse

Far Eastern Memorial Hospital

研究点 (2)

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