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Assessment of mental health status of first-line dental emergency medical personnel during novel coronavirus pneumonia (COVID-19) pandemic
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注册号:

Registration number:

ChiCTR2000031538 

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:

口腔急诊一线医护人员在新型冠状病毒肺炎(COVID-19)疫情期的心理健康状况评估 

Public title:

Assessment of mental health status of first-line dental emergency medical personnel during 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:

口腔急诊一线医护人员在新型冠状病毒肺炎(COVID-19)疫情期的心理健康状况评估 

Scientific title:

Assessment of mental health status of first-line dental emergency medical personnel during novel coronavirus pneumonia (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:

陶疆 

研究负责人:

朱亚琴 

Applicant:

Jiang Tao 

Study leader:

Yaqin Zhu 

申请注册联系人电话:

Applicant telephone:

+86 18516182761 

研究负责人电话:

Study leader's telephone:

+86 13817091896 

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:

doctor_taojiang@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zyq1590@163.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:

上海市黄浦区瞿溪路500号5楼口腔综合科 

研究负责人通讯地址:

上海市黄浦区瞿溪路500号5楼口腔综合科 

Applicant address:

500 Quxi Road, Huangpu District, Shanghai, China 

Study leader's address:

500 Quxi Road, Huangpu District, Shanghai, China 

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:

上海交通大学医学院附属第九人民医院 

Applicant's institution:

Ninth People's Hospital, Shanghai Jiao Tong University School of 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:

SH9H-2020-T55-2 

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:

上海交通大学医学院附属第九人民医院伦理委员会 

Name of the ethic committee:

Medical ethics committee of the ninth people's hospital, Shanghai Jiao Tong University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-03 

伦理委员会联系人:

甄红 

Contact Name of the ethic committee:

Hong Zhen 

伦理委员会联系地址:

上海市制造局路639号 

Contact Address of the ethic committee:

639 Zhizaoju Road, Huangpu District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13817026764 

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:

上海交通大学医学院附属第九人民医院 

Primary sponsor:

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine 

研究实施负责(组长)单位地址:

上海市黄浦区瞿溪路500号5楼口腔综合科 

Primary sponsor's address:

500 Quxi Road, Huangpu District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属第九人民医院

具体地址:

上海市黄浦区瞿溪路500号5楼口腔综合科

Institution
hospital:

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Address:

500 Quxi Road, Huangpu District, Shanghai

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

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:

本研究将致力于评估口腔急诊一线医护人员在疫情期间的心理健康状况,并研究相关干预措施,为今后应对突发公共卫生事件时,口腔急诊一线人员的心理健康预案建立提供参考。 

Objectives of Study:

This study aims to evaluate the mental health status of first-line dental emergency medical personnel during the epidemic period, and to study relevant intervention measures, to provide a reference for the establishment of mental health plan for first-line dental emergency medical staff in the future in response to public health emergencies. 

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.知情同意。 2.筛选时年龄20-65 岁,性别不限。 3.口腔急诊医护人员。 

Inclusion criteria

1. Informed consent; 2. Aged 20-65 years; 3. Dental emergency medical staff. 

排除标准:

1.未曾于口腔急诊一线临床值班。 2.之前有心理疾病史。 3.药物滥用者。 

Exclusion criteria:

1. Never worked on first-line clinical duty in the dental emergency department; 2. Having a history of mental illness; 3. Drug abusers. 

研究实施时间:

Study execute time:

From2020-04-03To 2020-09-30 

干预措施:

Interventions:

组别:

医护人员组

样本量:

123

Group:

Medical personnel group

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):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属第九人民医院 

单位级别:

三甲医院 

Institution
hospital:

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

急性应激障碍

指标类型:

主要指标 

Outcome:

ASDS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

压力知觉

指标类型:

主要指标 

Outcome:

PSS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁

指标类型:

主要指标 

Outcome:

PHQ

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

广泛焦虑

指标类型:

主要指标 

Outcome:

GAD

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 20 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):

非随机对照试验

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

N/A

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):

研究者根据研究进程选择具体方式公开原始数据

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

According to the research process,the research team chooses a specific way to disclose the recording of the experiment.

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:

研究者将根据临床评估及实验记录,将数据及时、完整、正确、清晰地载入电子数据文件分类保存,并有多个备份保存于不同磁盘或记录介质上,妥善保存,防止破坏。

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

Researchers will load the data into electronic data files in a timely, complete, accurate, and clear manner based on clinical evaluation and experimental records, and save them in multiple categories. Multiple backups are stored on different disks or recording media, and properly stored to prevent damage.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-04-03
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