今天是:2022-07-07 星期四

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件。 针刺改善失眠患者睡眠和心理异常的随机临床对照研究
下载XML文档

注册号:

Registration number:

ChiCTR2100049172 

最近更新日期:

Date of Last Refreshed on:

2022-04-03 

注册时间:

Date of Registration:

2021-07-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件。 针刺改善失眠患者睡眠和心理异常的随机临床对照研究 

Public title:

The effects of acupuncture on sleep quality and psychological symptoms of patients with insomnia: study protocol for a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

针刺改善失眠患者睡眠和心理异常的随机临床对照研究 

Scientific title:

The effects of acupuncture on sleep quality and psychological symptoms of patients with insomnia: study protocol for a randomized controlled trial 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

ChiMCTR2100005096 

申请注册联系人:

王丽芬 

研究负责人:

盛刚 

Applicant:

Wang Lifen 

Study leader:

Sheng Gang 

申请注册联系人电话:

Applicant telephone:

+86 13669289352 

研究负责人电话:

Study leader's telephone:

+86 13669289352 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

drwhat@163.com 

研究负责人电子邮件:

Study leader's E-mail:

drwhat@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

陕西省中医医院 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

西安市西华门4号 

研究负责人通讯地址:

西安市西华门4号 

Applicant address:

4 Xihuamen, Xi'an, Shaanxi 

Study leader's address:

4 Xihuamen, Xi'an, Shaanxi 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

陕西省中医医院 

Applicant's institution:

Shaanxi Provincial Hospital of Chinese Medicine 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

陕西省中医医院 

Primary sponsor:

Shaanxi University of Traditional Chinese Medicine  

研究实施负责(组长)单位地址:

西安市西华门4号 

Primary sponsor's address:

4 Xihuamen, Xi'an, Shaanxi 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

陕西

市(区县):

西安

Country:

China

Province:

Shaanxi

City:

Xi'an

单位(医院):

陕西省中医医院

具体地址:

西华门4号

Institution
hospital:

Shaanxi Provincial Hospital of Chinese Medicine

Address:

4 Xihuamen

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

失眠 

Target disease:

insomnia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

主要目的:研究针对对失眠患者睡眠质量和心理症状的影响  

Objectives of Study:

Main purpose: To investigate the effects of acupuncture for insomnia in improving sleep quality and psychosocial disorders.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.符合精神障碍诊断与统计手册对失眠的诊断标准; 2.18-65岁(男或女); 3.每周至少经历3次持续1个月以上; 4.不服用任何改善失眠的药物或停药3周以上; 5.有焦虑等心理症状(焦虑自评量表SAS评分)≥50)或抑郁(自我报告抑郁量表SDS评分)≥50); 6.同意参与试验并随机分配到任何研究组。 

Inclusion criteria

1. Meet the diagnostic criteria for insomnia in the Diagnostic and Statistical Manual of Mental Disorders; 2. Aged 18 to 65 years (male or female); 3. Experience at least 3 times a week for more than 1 month; 4. Do not take any drugs to improve insomnia or stop the drug for more than 3 weeks; 5. Have psychological symptoms such as anxiety (self-reported anxiety scale SAS score) >= 50) or depression (self-reported depression scale SDS score) >= 50); 6. Consent to participate in the trial and be randomly assigned to any study group. 

排除标准:

1.失眠是由神经系统疾病引起的,包括中风、帕金森病等; 2.严重器质性疾病和其他慢性疾病,包括心脏病、肝脏或肾脏疾病、血小板减少伴出血倾向; 3.怀孕或者未采取适当节育措施的育龄妇女; 4.在针灸过程中晕倒或怕血的严重发作; 5.穴位感染或发炎; 6.酒精和/或其他药物滥用或依赖 。 

Exclusion criteria:

1. Insomnia is caused by neurological diseases, including stroke, Parkinson's disease, etc.; 2. Severe organic diseases and other chronic diseases, including heart disease, liver or kidney disease, thrombocytopenia with bleeding tendency; 3. Women of childbearing age who are pregnant or who have not taken appropriate birth control measures; 4. Severe episodes of fainting or fear of blood during acupuncture; 5. Acupoint infection or inflammation; 6. Alcohol and/or other drug abuse or dependence. 

研究实施时间:

Study execute time:

From2022-01-01To 2022-02-28 

征募观察对象时间:

Recruiting time:

From2021-10-01To 2021-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

126

Group:

experimental group

Sample size:

干预措施:

针灸

干预措施代码:

Intervention:

manual acupuncture

Intervention code:

组别:

对照组

样本量:

126

Group:

control group

Sample size:

干预措施:

假针灸

干预措施代码:

Intervention:

sham acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

陕西省中医医院 

单位级别:

三级甲等 

Institution
hospital:

Shaanxi University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

匹兹堡睡眠质量指数

指标类型:

主要指标 

Outcome:

Pittsburgh Sleep Quality Index score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑自评量表

指标类型:

次要指标 

Outcome:

self-assessment anxiety scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁自评量表

指标类型:

次要指标 

Outcome:

self-assessment anxiety scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量量表

指标类型:

次要指标 

Outcome:

Medical Outcomes Study 36-Item Short-Form Health Survey

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

252名受试者在基线评估后随机分为手针组(n=126,预期)和假针组(n=126,预期)。随机序列将由一名研究助理使用统计分析软件(SAS 9.1)生成,该助理不清楚参与者的招募情况。随机化号码将被密封在计算机制作的随机化不透明信封中。信封上只打印筛选序列号。研究人员在基线评估后筛选出符合条件的患者,将信封分开,然后将患者分为手针组或假针组。

Randomization Procedure (please state who generates the random number sequence and by what method):

252 participants will be randomly assigned to manual acupuncture group (n=126, expected) or sham acupuncture group (n=126, expected) after the baseline assessment. The randomization sequence will be generated using the Statistical Analysis Software (SAS 9.1) by a research assistant who is unclear for the recruitment.

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

通过ResMan提供原始数据查询

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

IPD will be public accessable via ResMan.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

原始数据包括纸质版病例报告表和电子版信息,在陕西省中医院保存。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The raw data includes the printed case report forms and electronic edition, all of these are saved in Shaanxi Provincial Hospital of Chinese Medicine.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-07-24
返回列表