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Investigation on the mental health status and intervention of the medical staff of the national rescue medical team in hubei province during the pandemic of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000032368 

最近更新日期:

Date of Last Refreshed on:

2020-04-26 

注册时间:

Date of Registration:

2020-04-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

抗击新型冠状病毒肺炎(COVID-19)疫情期间国家援鄂医疗队医护人员心理健康状况调查及干预研究 

Public title:

Investigation on the mental health status and intervention of the medical staff of the national rescue medical team in hubei province during the pandemic of novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

国家援鄂医疗队医护人员灵心理健康状况调查及干预研究 

Scientific title:

Investigation on the mental health status and intervention of the medical staff of the national rescue medical team in hubei province 

研究课题代号(代码):

Study subject ID:

首都特色临床应用研究(Z181100001718135) ,中日友好医院院级科研项目(2016-2-GL-2) 

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:

尹琳 

研究负责人:

尹琳 

Applicant:

Yin Lin 

Study leader:

Yin Lin 

申请注册联系人电话:

Applicant telephone:

+86 010 84205706 

研究负责人电话:

Study leader's telephone:

+86 010 84205706 

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:

421795785@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jade_yl@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:

北京市朝阳区樱花东街2号中日友好医院 

研究负责人通讯地址:

北京市朝阳区樱花东街2号中日友好医院 

Applicant address:

2 Yinghua Street East, Chaoyang District, Beijing, China 

Study leader's address:

2 Yinghua Street East, Chaoyang District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100029 

研究负责人邮政编码:

Study leader's postcode:

100029 

申请人所在单位:

中日友好医院 

Applicant's institution:

China-Japan Friendship Hospital 

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:

中日友好医院 

Primary sponsor:

China-Japan Friendship Hospital 

研究实施负责(组长)单位地址:

北京市朝阳区樱花东街2号中日友好医院 

Primary sponsor's address:

2 Yinghua Street East, Chaoyang 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):

中日友好医院

具体地址:

北京市朝阳区樱花东街2号中日友好医院

Institution
hospital:

China-Japan Friendship Hospital

Address:

2 Yinghua Street East, Chaoyang District

经费或物资来源:

首都特色临床应用研究(Z181100001718135) ,中日友好医院院级科研项目(2016-2-GL-2) 

Source(s) of funding:

Beijing Municipal Science & Technology Commission (Z181100001718135), Institute Level Scientific Research Project of China Japan Friendship Hospital (2016-2-GL-2) 

研究疾病:

新型冠状病毒肺炎(COVID-19);心理应激,灵性需求,焦虑,抑郁,睡眠障碍 

Target disease:

Novel Coronavirus Pneumonia (COVID-19); Psychological stress, Spiritual needs, Anxiety, Depression, Sleep disorders 

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:

探索性研究/预试验 

Study phase:

研究目的:

对国家医疗队员心理状态进行专业评估,并根据存在的倾向性问题及时采取干预,提供心理援助,从而减少抗疫形势和工作状态带给医疗队员的心理冲击,保证救援任务有质有量地进行。1、通过焦虑、抑郁情绪测量,灵性照护需求调查,压力知觉测量、社会支持系统调查和睡眠状况评估等心理学和生理学的专业测量工具,评估医疗队员心理和生理状况。 2、根据调查结果分析造成心理状态差异的影响因素,提出干预措施。 3、按照试验组和对照组进行对照研究,验证干预效果。 

Objectives of Study:

Carry on the specialized evaluation to the national medical team member's mental state, and according to the existence tendency question takes the timely intervention, provides the psychological assistance, thus reduces the anti-epidemic situation and the work condition to bring the medical team member's psychological impact, guarantees the rescue task to have the quality to carry on the quantity. 1. Assessed the psychological and physiological status of medical team members by psychological and physiological professional measuring tools such as anxiety and depression, spiritual care needs survey, stress perception survey, social support system survey and sleep condition assessment. 2. According to the survey results, analyze the influencing factors that cause the difference in psychological state, and propose intervention measures. 3. A control study was conducted according to the experimental group and the control group to verify the intervention effect. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

①知情同意,自愿参加本研究; ②已在武汉重症病房从事医疗护理工作连续4周及以上。 

Inclusion criteria

1. Have informed consent to participate in this study voluntarily; 2. Has been engaged in medical care in wuhan intensive care unit for 4 weeks or more. 

排除标准:

①身体状况不佳; ②既往或目前正在使用精神类药物者。 

Exclusion criteria:

1. Poor health; 2. previous or current use of psychotropic drugs. 

研究实施时间:

Study execute time:

From2020-04-30To 2020-10-31 

干预措施:

Interventions:

组别:

实验组

样本量:

58

Group:

Experimental group

Sample size:

干预措施:

叙事治疗

干预措施代码:

Intervention:

Narrative therapy

Intervention code:

组别:

实验组

样本量:

58

Group:

Experimental group

Sample size:

干预措施:

团体心理辅导

干预措施代码:

Intervention:

Group psychological counseling

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):

华中科技大学武汉同济医院中法新城院区 

单位级别:

三甲医院 

Institution
hospital:

The China-French xincheng district of Wuhan Tongji hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中日友好医院 

单位级别:

三甲医院 

Institution
hospital:

China-Japan Friendship Hospital  

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:

Acute stress disorder

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

指标类型:

主要指标 

Outcome:

Anxiety

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:

Depression

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:

Perception of stress

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

灵性照护需求

指标类型:

主要指标 

Outcome:

The need for spiritual care

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会支持水平

指标类型:

主要指标 

Outcome:

Social support

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡眠障碍

指标类型:

主要指标 

Outcome:

Sleep disorders

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:

调查问卷

组织:

Sample Name:

questionnaire

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 26 years
最大 Max age 55 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

非随机对照研究

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

Non-randomized controlled studies

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

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:

 2020-04-26
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