Today is 2019-12-13

A survey on sleep quality of college students
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注册号:

Registration number:

ChiCTR1900027629 

最近更新日期:

Date of Last Refreshed on:

2019-11-22 

注册时间:

Date of Registration:

2019-11-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

大学生睡眠质量调查 

Public title:

A survey on sleep quality of college students 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于“因时-因地-因人制宜”的中医药防治失眠及睡眠健康管理方案研究 

Scientific title:

Research on prevention and treatment of insomnia and sleep health management program based on the theory of “three causes and measures theory” 

研究课题代号(代码):

Study subject ID:

2018YFC1705602 

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:

 

申请注册联系人:

黄亮亮 

研究负责人:

刘玲 

Applicant:

Liangliang Huang 

Study leader:

Ling Liu 

申请注册联系人电话:

Applicant telephone:

+86 18986159122 

研究负责人电话:

Study leader's telephone:

+86 18971537282 

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:

huangll1991@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

lingliu07199@aliyun.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

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:

湖北省武汉市武昌区昙华林路特1号 

研究负责人通讯地址:

湖北省武汉市武昌区花园山4号 

Applicant address:

1 Tan-Hua-Lin Road, Wuchang District, Wuhan, Hubei, China 

Study leader's address:

4 Garden Hill, Wuchang District, Wuhan, Hubei, China  

申请注册联系人邮政编码:

Applicant postcode:

430061 

研究负责人邮政编码:

Study leader's postcode:

430061 

申请人所在单位:

湖北中医药大学 

Applicant's institution:

Hubei University of Chinese Medicine  

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

HBZY2019-C41-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

湖北省中医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Hubei Provincial Hospital of Traditional Chinese Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-15 

伦理委员会联系人:

张馨 

Contact Name of the ethic committee:

Xin Zhang 

伦理委员会联系地址:

湖北省武汉市武昌区花园山4号 

Contact Address of the ethic committee:

4 Garden Hill, Wuchang District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027-88920956 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ec@hbhtcm.com 

研究实施负责(组长)单位:

湖北省中医院 

Primary sponsor:

Hubei Provincial Hospital of Traditional Chinese Medicine  

研究实施负责(组长)单位地址:

湖北省武汉市武昌区花园山4号 

Primary sponsor's address:

4 Garden Hill, Wuchang District, Wuhan, Hubei, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

国家科学技术部 

Source(s) of funding:

Ministry of Science & Technique, China 

研究疾病:

失眠 

Target disease:

insomnia 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

以中医“三因制宜”理论为指导,调查大学生的睡眠情况。 

Objectives of Study:

Based on the theory of three causes and measures,to investigate the sleep situation of college students. 

药物成份或治疗方案详述:

本研究采用问卷的形式,调查中医药大学本科生的睡眠情况。 

Description for medicine or protocol of treatment in detail:

This study used a questionnaire to investigate the sleep status of undergraduates in the university of Chinese medicine. 

研究设计:

整群随机抽样 

Study design:

Cluster randomly sampling 

纳入标准:

武汉、广州、兰州三地区中医药大学在校1-3年级本科生。 

Inclusion criteria

Wuhan, guangzhou, lanzhou three areas of traditional Chinese medicine university in the 1-3 year undergraduate students. 

排除标准:

无。 

Exclusion criteria:

No. 

研究实施时间:

Study execute time:

From2019-12-01To 2021-06-30 

干预措施:

Interventions:

组别:

Case series

样本量:

4000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

湖北省中医院 

单位级别:

三甲 

Institution
hospital:

Hubei Provincial Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospita 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省中医院 

单位级别:

三甲 

Institution
hospital:

GuangDong Province Hospital Of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

甘肃 

市(区县):

兰州 

Country:

China 

Province:

Gansu 

City:

Lanzhou 

单位(医院):

甘肃中医药大学 

单位级别:

 

Institution
hospital:

University of Traditional Chinese Medicine  

Level of the institution:

 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市中医医院 

单位级别:

三甲 

Institution
hospital:

Wuhan Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

大学生人口学信息表

指标类型:

次要指标 

Outcome:

Demographic information sheet for college students

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠指数量表

指标类型:

主要指标 

Outcome:

PSQI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医体质量表

指标类型:

主要指标 

Outcome:

CCMQ

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:

SAS

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:

SDS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

大学生睡眠相关因素问卷

指标类型:

次要指标 

Outcome:

College students sleep related factors questionnaire

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:

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 years
最大 Max age 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):

黄亮亮;采用整群、分层抽样的方法。

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

Liangliang Huang;Adapt the cluster and stratified sampling.

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

临床试验公共管理平台ResMan www.medresman.org

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

ResMan is the public administration platform for Shared clinical trials,ResMan www.medresman.org

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:

电子采集和管理系统

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

EDC

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-11-22
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