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The Study of the Relationship of Insomnia in the Traditional Chinese Medicine and Western Medicine at Local Clinic

2017年5月23日 更新者:Ching-Liang Hsieh、China Medical University Hospital

Insomnia is one of the most main diseases of civilization in the world, which chronic insomnia is up to 30% in Taiwan under the latest statistics and a common disease which appears to sleep difficultly, sleep interrupted, wake up early or wake up still tired. Long-term persistence of these symptoms will lead to the occurrence of mental illness and then affect people's emotional behavior and cognitive memory, showing that insomnia is an important modern health issues. Recently, "individual response patterns" was proposed by modern medicine. This thinking process and spirit seems to be compatible with the traditional Chinese medicine (TCM) therapy of "Differential Treatment". The purpose of this study, the Athens Insomnia Scale (AIS), commonly used to quickly screen for insomnia patients and the evaluation of Western medicine efficacy in Western medicine clinic, and investigation of Syndrome Type of TCM to find out whether with Syndrome Type of TCM and AIS in the associated factors, and confirm the necessity and importance of Syndrome Type of TCM, for future reference and basis for the development of integrated medicine.

In the cross-section study with an interview on survey, sampling Miaoli County an Chinese medicine clinic, in line with standard sampling of 200 patients with insomnia were recruited. The questionnaires contained two instruments including Athens Insomnia Scale (AIS), and Syndrome Type of TCM questionnaire. Cross-table, chi-square test, variance analysis and Pearson product-moment correlation was used to find the relation.

研究概览

地位

未知

条件

详细说明

Insomnia is a common sleep disturbance, there were more than a quarter of people with sleep disorders, the prevalence with more and higher, seriously affecting the health and quality of life. The Athens Insomnia Scale (referred to as AIS) can help physicians more accurately diagnose and understand the state of insomnia patients. The purpose of this study was investigated the correlation among the disease status, treatment and AIS assessment, hoping enough traditional Chinese physician and Western physician's clinical reference. Methods: This study used the cross-sectional questionnaire survey with the convenience sampling method. Screened 200 patients according to the diagnostic criteria for insomnia and conducted a survey from the local clinic at Miaoli County.

研究类型

观察性的

注册 (预期的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Miaoli County、台湾、350
        • 招聘中
        • Zhunan Ho-Te Chinese medicine clinic
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

an Chinese medicine clinic at Miaoli County

描述

Inclusion Criteria:

  • Compliance with the International Statistical Classification of Diseases and Related Health Problems (ICD)-10 and the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV and other international standards in the diagnosis of non-organic insomnia criteria to determine the main diagnosis and secondary diagnosis of insomnia: A. Complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early, or sleep that is chronically nonrestorative or poor in quality. B. Any sleep difficulty at least three times a week and during the period of the last month. C. Over concerns or worries about sleep. D. The night time sleep difficulty is related to daytime impairment: mood disturbance or social and vocational dysfunction
  • Cooperation with physician voluntarily, communication with physician normally

Exclusion Criteria:

  • Teenagers and babies
  • Insomnia associated with other sleep disorders most commonly includes sleep related breathing disorders (e.g.,obstructive sleep apnea), movement disorders (e.g.,restless legs or periodic limb movements during sleep) or circadian rhythm sleep disorders;
  • Insomnia due to medical or psychiatric disorders (Schizophrenia, paranoia, affective psychosis, bipolar disorder, depression, organic psychosis like brain injury, epilepsy, dementia and so on), or to drug/substance (comorbid insomnia); and
  • Primary insomnias including psychophysiological, idiopathic, and paradoxical insomnias.
  • Lack of intelligence or other reasons it is difficult to correctly fill the questionnaire

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Insomnia
those with unsatisfactory sleep quantity and/or quality (difficulty with sleep induction, awakenings during the night, early morning awakening, total sleep time, and overall quality of sleep), complaint of a minimum frequency (at least three times a week) and duration (1 month), marked distress caused by the sleep problem and/or interference with ordinary activities of daily living

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Questionnaires and Data analysis
大体时间:Patients were estimated any sleep difficulty during the period of last 4 weeks and then finished record about 15-20 minutes. A copy was done after 2 weeks. From date of randomization until the date of final documented progression, assessed 2 months.
Scores for each sleep dimension on the AIS questionnaire compared to Syndrome Type of TCM questionnaire. The AIS questionnaire contains 8 items which are rated on 0-3 scale ("0" means "no problem", "1" means "mild problem", "2" means "marked problem", "3" means "severe problem"). For each dimension, item scores are coded, summed, and transformed on to a scale from 0 (best sleep) to 24 (worst sleep) as an individual's sleep outcome. Syndrome Type of TCM questionnaire contains 6 patterns: pattern of yin deficiency with effulgent fire, pattern of deficiency of both heart and spleen, pattern of liver depression transforming into fire, pattern of phlegm-heat harassing internally, pattern of heart and gallbladder qi insufficiency, the other patterns as well and case numbers are counted as an TCM pattern's outcome. Finally, study the distribution law of insomnia's TCM pattern identification and relative factors of AIS.
Patients were estimated any sleep difficulty during the period of last 4 weeks and then finished record about 15-20 minutes. A copy was done after 2 weeks. From date of randomization until the date of final documented progression, assessed 2 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ching-Liang Hsieh、China Medical University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年5月19日

初级完成 (预期的)

2018年5月4日

研究完成 (预期的)

2018年5月4日

研究注册日期

首次提交

2017年5月18日

首先提交符合 QC 标准的

2017年5月23日

首次发布 (实际的)

2017年5月24日

研究记录更新

最后更新发布 (实际的)

2017年5月24日

上次提交的符合 QC 标准的更新

2017年5月23日

最后验证

2017年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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