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Survey of psychological status and related factors of emergency medical staff in the country during the novel coronavirus pneumonia (COVID-19) pandemic
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注册号:

Registration number:

ChiCTR2000031533 

最近更新日期:

Date of Last Refreshed on:

2020-04-03 

注册时间:

Date of Registration:

2020-04-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)流行期间全国急诊医护人员心理状况调查及相关因素分析 

Public title:

Survey of psychological status and related factors of emergency medical staff in the country during the novel coronavirus pneumonia (COVID-19) pandemic 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎流行期间全国急诊医护人员心理状况调查及相关因素分析 

Scientific title:

Survey of psychological status and related factors of emergency medical staff in the country during the COVID-19 pandemic 

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:

 

申请注册联系人:

刘霜 

研究负责人:

于学忠 

Applicant:

Shuang Liu 

Study leader:

Xuezhong Yu 

申请注册联系人电话:

Applicant telephone:

+86 13693292516 

研究负责人电话:

Study leader's telephone:

+86 13601262164 

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:

cinderella82005@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yxzpumch@126.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:

北京东城区帅府园1号北京协和医院 

研究负责人通讯地址:

北京东城区帅府园1号 

Applicant address:

1 Shuai-Fu-Yuan, Dongdan, Dongcheng District, Beijing, China 

Study leader's address:

1 Shuai-Fu-Yuan, Dongdan, Dongcheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100730 

研究负责人邮政编码:

Study leader's postcode:

100730 

申请人所在单位:

北京东城区帅府园1号北京协和医院 

Applicant's institution:

Peking Union Medical College Hospital 

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:

S-K1053 

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:

中国医学科学院北京协和医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-27 

伦理委员会联系人:

黄辉 

Contact Name of the ethic committee:

Hui huang 

伦理委员会联系地址:

北京东城区帅府园1号北京协和医院 

Contact Address of the ethic committee:

Peking Union Medical College Hospital, 1 Shuai-Fu-Yuan, Dongdan, Dongcheng District, Beijing, China 

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:

北京协和医院 

Primary sponsor:

Peking Union Medical College Hospital 

研究实施负责(组长)单位地址:

北京东城区帅府园1号北京协和医院 

Primary sponsor's address:

1 Shuai-Fu-Yuan, Dongdan, Dongcheng District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京协和医院

具体地址:

北京东城区帅府园1号北京协和医院

Institution
hospital:

Peking Union Medical College Hospital

Address:

1 Shuai-Fu-Yuan, Dongdan, Dongcheng District

经费或物资来源:

无 

Source(s) of funding:

No funding 

研究疾病:

抑郁状态 

Target disease:

depression 

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:

评估新型冠状病毒肺炎期间急诊医护人员心理状态及相关因素分析 

Objectives of Study:

Evaluation of psychological status and related factors of emergency medical staff during assessment of COVID-19 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.在2019年11月至2020年6月在岗的中国急诊医护人员; 2.年龄大于18岁,性别不限; 3.符合伦理标准,并能够自行签署知情同意书。 

Inclusion criteria

1. Chinese emergency medical staff on duty from November 2019 to June 2020; 2. Aged >= 18 years; 3. Meet ethical standards and be able to sign informed consent. 

排除标准:

1.被确诊患有精神心理疾病; 2.正在服用抗精神病药物; 3.正在参与其他药物临床实验。 

Exclusion criteria:

1. Have been diagnosed with psychologic illness; 2. Taking antipsychotic drugs; 3. Participating in clinical trials of other drugs. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-06-30 

干预措施:

Interventions:

组别:

Case series

样本量:

7000

Group:

Case series

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京协和医院 

单位级别:

三甲医院 

Institution
hospital:

Peking Union Medical College Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

PHQ-9 得分

指标类型:

主要指标 

Outcome:

The score of PHQ-9

Type:

Primary 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:

n/a

组织:

Sample Name:

n/a

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

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 80 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):

n/a

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

N/A

盲法:

Blinding:

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):

由研究者线下公开原始数据

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

Sharing raw data offline by researchers

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:

由研究者发放网络调查问卷采集数据,通过问卷结果统计及管理数据

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

Collect data from the questionnaires issued by researchers, and collect statistics and manage data through the results of the questionnaires

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-04-03
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