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临床试验/NCT05517460
NCT05517460已完成不适用

The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Patient Assessment of Constipation Symptoms questionnaire

研究概览

简要总结

The purpose of the study is to examine the effect of auricular acupressure on improvement of constipation and heart rate variability among residents with schizophrenia in community rehabilitation Center.The hypothesis of this study is that residents with schizophrenia in Community Rehabilitation Center receiving auricular acupressure can improve the symptoms of constipation and heart rate variability.By identifying the effectiveness of auricular acupressure can reduce the occurrence of constipation; suitable care can be suggested to improve gastrointestinal health in residents of Schizophrenia in community rehabilitation center.

详细描述

Due to the use of psychiatric medication and the impairment of cognition lead to poor lifestyle which is result in constipation among the residents of community rehabilitation center.In addition, the residents affected by psychosis and poor cognition are hard to pay attention and implement on the non-pharmacological interventions completely with complicated process.Therefore, contriving a simple intervention, which may improve constipation and constipation-related symptoms. The purpose of this study is to examine the effectiveness of applying auricular acupressure for relieving the constipation symptoms of residents of Schizophrenia in community rehabilitation center. A cross-over study design is used for this study. The eligible participants were random assign to experimental group I or experimental group II. Experimental group I received 8 weeks of auricular acupressure then 8 weeks of routine health care of constipation. Experimental group II received same interventions in reverse order (8 weeks of routine health care of constipation then 8 weeks of auricular acupressure).In both groups, any interventions were stopped for two month as residual effect wash-out period after 8 weeks intervention. Outcome measures include demographic variables, general health status and defecation condition. Subjective defecation condition is related to self-perceived constipation measured by the Patient Assessment of Constipation Symptoms scale. Objective defecation condition includes frequency of defecation, the grade of Bristol Stool Scale and heart rate variability. Mean, standard deviation, frequency, percentage, t-test and chi-square test will be used to analyze the data. In addition, generalized estimating equations will be used to examine the effect of auricular acupressure on improving constipation. By identifying the effectiveness of auricular acupressure can reduce the occurrence of constipation; suitable care can be suggested to improve gastrointestinal health in residents of Schizophrenia in community rehabilitation center.

研究设计

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

入排标准

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

入选标准

  • •Living in community rehabilitation center for at least six months and above.
  • •Community rehabilitation center residents aged 40 and over.
  • •Clinical diagnosis of Schizophrenia.
  • •Having constipation-related symptoms: meet at least one of the following conditions:
  • •Chief complaint of discomfort of defecation such as difficulty in defecation, hard stool, straining during defecation, feeling of incomplete defecation, feeling of obstructed defecation, defecation frequency less than three times a week.
  • •Objective symptoms: Type 1 or 2 of Bristol Stool Form assessment.
  • •Long-term use(1 month and above) of laxatives such as MgO、Sennoside etc ., or need to use an enema to defecate.

排除标准

  • •Incapable of complying with the direction and responding to questionnaires.
  • •Having wound or local skin lesion on acupressure point.
  • •Having organic constipation caused by abdominal operation in the past.

研究组 & 干预措施

experimental group I(auricular acupressure and usual care)

Experimental

Experimental group I receives 8 weeks of auricular acupressure first, then interventions are stopped for two month as residual effect wash-out period. And after that Experimental group I receives 8 weeks of routine health care of constipation.

干预措施: Auricular acupressure (Other)

experimental group I(auricular acupressure and usual care)

Experimental

Experimental group I receives 8 weeks of auricular acupressure first, then interventions are stopped for two month as residual effect wash-out period. And after that Experimental group I receives 8 weeks of routine health care of constipation.

干预措施: health education (Other)

experimental group II(usual care and auricular acupressure)

Experimental

Experimental group II receives 8 weeks of routine health care of constipation first, then interventions are stopped for two month as residual effect wash-out period. And after that Experimental group II receives 8 weeks of auricular acupressure .

干预措施: Auricular acupressure (Other)

experimental group II(usual care and auricular acupressure)

Experimental

Experimental group II receives 8 weeks of routine health care of constipation first, then interventions are stopped for two month as residual effect wash-out period. And after that Experimental group II receives 8 weeks of auricular acupressure .

干预措施: health education (Other)

结局指标

主要结局

Patient Assessment of Constipation Symptoms questionnaire

时间窗: at eight weeks after intervention

Patient Assessment of Constipation Symptoms

Bristol Stool Scale

时间窗: at eight weeks after intervention

frequency of defecation, range of 1-7 and low score indicate constipation

heart rate variability.

时间窗: at eight weeks after intervention

heart rate variability.

Bristol Stool Scale

时间窗: at four weeks after intervention

frequency of defecation, range of 1-7 and low score indicate constipation

Patient Assessment of Constipation Symptoms questionnaire

时间窗: Baseline

Patient Assessment of Constipation Symptoms

Bristol Stool Scale

时间窗: Baseline

frequency of defecation, range of 1-7 and low score indicate constipation

heart rate variability.

时间窗: Baseline

heart rate variability.

heart rate variability.

时间窗: at four weeks after intervention

heart rate variability.

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

Huang, Hui-Chuan

The Efficacy of Auricular Acupressure on Improving Constipation among Residents in Community Rehabilitation Center

Taipei Medical University

研究点 (1)

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