跳至主要内容
临床试验/NCT05612646
NCT05612646已完成不适用

Taiwan Taichung Veterans General Hospital

Taichung Veterans General Hospital2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2020年9月11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
128
试验地点
2
主要终点
The Bristol Stool Form Scale

研究概览

简要总结

As a form of non-invasive auxiliary care, Traditional Chinese Medicine acupressure can prevent constipation, reduce medication for constipation, save medical costs, and alleviate constipation among inpatients in neurology departments, as well as improve patients' general ease and comfort of defecation, thereby improving their quality of life. It also provides clinical nursing staff with a more effective, safer, and more comfortable auxiliary method of preventing constipation, and can be used as a reference for the nursing of such patients.

详细描述

Background: Constipation is a common problem among geriatric patients and in neurology departments. However, using stool softeners and enemas yield only temporary effects and may even lead to alternating constipation, diarrhea, and metabolic disorders. Because of its non-invasive nature, Acupressure can be used as adjuvant therapy of integrated traditional Chinese and western medicine to prevent constipation among inpatients in neurology departments. It is necessary to verify that Acupressure can be applied to avoid and alleviate patients' constipation, improve their comfort, and improve their quality of life.

Objective

To explore the effect of Acupressure in alleviating constipation among inpatients in neurology departments.Method: A randomized controlled two-group pre-test and post-test experiment design were adopted in this study; neurology department inpatients were randomly assigned to either the experimental group, which comprised 64 subjects receiving Acupressure on three acupoints (Tianshu, ST25: Stomach Meridian 25; Zhongwan CV12: Conception Vessel 12; Qihai CV6: Meridian Vessel 6) or the control group which comprised 64 subjects receiving routine nursing and fake Acupressure. The research tools included the Bristol Stool Form and Constipation Assessment Scale.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Use the random number generator of EXCEL to generate the random number assigned by the computer, and put the serial number in the sealed envelope in sequence. After the patients completed the pre-test, the sealed envelopes were opened in sequence, and the patients were randomly assigned to the experimental group and the routine care group. The study used an assessor blinding design, that is, the data collectors were unaware of the patient group assignments until the end of the study

入排标准

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

入选标准

  • Age ≥ 20 years old
  • Established diagnosis of stroke (ischemic, hemorrhagic acute phase)
  • NIHSS 1-20 points
  • Undiagnosed within three months before admission With intestinal disease and no rectal resection
  • meeting the diagnostic criteria for functional constipation (Rome IV).

排除标准

  • Abdominal surgery or abdominal radiotherapy within three months
  • Abdominal cancer including liver, large intestine, lymph, and pelvic cavity, etc.,
  • Massive ascites
  • There are implants in the abdominal cavity, such as V-P Shunt, L-P Shunt, CAPD, etc.

结局指标

主要结局

The Bristol Stool Form Scale

时间窗: Assessment from the first day to the seventh day after treatment

bach's alpha of The Bristol Stool Form Scale. Classification: Type 1: hard balls (difficult to pass through), Type 2: sausage-like, but with uneven surface Type 3: sausage-like, but with cracks on the surface, Type 4: like sausage or snake Surface is smooth, type 5: soft lumps with smooth broken edges (easy to pass), type 6: fluffy lumps with rough edges, mushy stool, type 7: watery, no solid lumps (completely liquid), type 1 Types 3 and 2 indicate constipation; Types 3 and 4 are ideal stool shapes, especially Type 4 is the easiest to defecate; Types 5 to 7 are likely to have diarrhea

The constipation assessment scale scores

时间窗: Assessment from the first day to the seventh day after treatment

Constipation Assessment Scale (CAS), a total of 8 questions, 0 points: no, 1 point: yes, but not severe, 2 points. Very serious, the higher the score (0-16 points), the more severe the constipation symptoms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验