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Psychological responses of medical staff during COVID-19 and the adjustment effect of brief mindfulness meditation
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注册号:

Registration number:

ChiCTR2000039002 

最近更新日期:

Date of Last Refreshed on:

2020-10-13 

注册时间:

Date of Registration:

2020-10-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

武汉一线抗疫后医护人员心理状态调查及短时正念冥想的干预效果研究 

Public title:

Psychological responses of medical staff during COVID-19 and the adjustment effect of brief mindfulness meditation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

心理学 

Scientific title:

psychology 

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:

刘韵资 

研究负责人:

刘韵资 

Applicant:

Liu Yunzi 

Study leader:

刘韵资 

申请注册联系人电话:

Applicant telephone:

13916290457 

研究负责人电话:

Study leader's telephone:

13916290457 

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:

kekeyiran@126.com 

研究负责人电子邮件:

Study leader's E-mail:

kekeyiran@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:

上海市杨浦区翔殷路800号 

研究负责人通讯地址:

上海市杨浦区翔殷路800号 

Applicant address:

Second Military Medical University 800 Xiangyin Road 200433 Shanghai, P.R. of China 

Study leader's address:

Second Military Medical University 800 Xiangyin Road 200433 Shanghai, P.R. of 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:

海军军医大学 

Applicant's institution:

Navy Medical University 

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:

20200326 

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:

海军军医大学伦理委员会 

Name of the ethic committee:

The Ethics Review Committee of Naval Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-02 

伦理委员会联系人:

刘鹏 

Contact Name of the ethic committee:

Liu Peng 

伦理委员会联系地址:

上海市杨浦区海军军医大学 

Contact Address of the ethic committee:

Navy Medical University, Shanghai, 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:

海军军医大学 

Primary sponsor:

Navy Medical University 

研究实施负责(组长)单位地址:

上海市杨浦区翔殷路800号 

Primary sponsor's address:

Faculty of Psychology and Mental Health, Second Military Medical University, 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:

Province:

City:

单位(医院):

海军军医大学

具体地址:

上海市杨浦区翔殷路800号

Institution
hospital:

Address:

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation 

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:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

评估抗击新冠肺炎医护工作者的心理及睡眠状况,以随机对照研究的形式检验短时正念冥想训练的心理干预效果。 

Objectives of Study:

To evaluate the psychological and sleep status of medical staff during COVID-19 and to test the effect of psychological intervention based on brief mindfulness meditation (BMM) in the form of a randomized controlled study.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

(1)18岁以上; (2)有在武汉一线抗击新冠肺炎工作史; (3)可独立配合医生完成各种量表测评及相应的检测; (4)有随身手机或平板等移动通讯装备; (5)移动装备可以随时上网; 

Inclusion criteria

(1)Age above 18; (2)Have been working in Wuhan hospital; (3)Can independently cooperate with doctors to complete various scale assessments and corresponding tests; (4)Have mobile communication equipment such as mobile phones or tablets; (5)Mobile equipment can go online at any time. 

排除标准:

1)患有严重的心、脑、肺、肾、肝脏等内科疾病或肿瘤患者; 2)不能配合调查、干预的患者; 符合上述任一项者,即予排除 

Exclusion criteria:

(1) Patients with serious heart, brain, lung, kidney, liver and other medical diseases or tumors; (2) Patients who can not cooperate with the investigation and intervention; Those who meet any of the above items shall be excluded.  

研究实施时间:

Study execute time:

From2021-01-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2021-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

200

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

冥想组

样本量:

200

Group:

BMM group

Sample size:

干预措施:

短时正念冥想

干预措施代码:

Intervention:

brief mindfulness meditation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

china 

Province:

zhejiang 

City:

hangzhou 

单位(医院):

空军杭州特勤疗养中心 

单位级别:

副师 

Institution
hospital:

Air Force Health Care Center Special Services Hangzhou  

Level of the institution:

Associate Division 

测量指标:

Outcomes:

指标中文名:

阿森斯失眠量表

指标类型:

主要指标 

Outcome:

AIS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

应激感受量表

指标类型:

主要指标 

Outcome:

PSS-10

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

广泛性焦虑障碍量表

指标类型:

主要指标 

Outcome:

GAD-7

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

应激感受量表

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:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

none

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 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):

实验者通过电脑随机数分配被试。被试被分到实验组和对照组的概率为50:50。在首日训练中,被试到达实验室后,被赋予对应的随机数,并要求坐在随机数对应的电脑上。实际上,如果数字是偶数,被试属于实验组,如果是奇数,则被试被分到对照组。

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

articipants were randomly assigned to intervention and control groups with a 50:50 allocation ratio. In the first day of training, upon arriving at the laboratory, participants were informed of their number and that they should use the computer with the same number. The number was generated automatically

盲法:

双盲实验

Blinding:

double-blind

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):

百度云盘(https://pan.baidu.com/)

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

Baidu Cloud Disk(https://pan.baidu.com/)

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:

研究数据专门的助理人员进行收集。试验结束后,心理量表存放在资料室,由专人管理。电子数据保存于教研室专用电脑,由专人处理。

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

Data were collected by researcher assistant. After the study, psychological questionnaires were locked in reference room of department and managed by researchers.Electronic data were saved in the data bank of department and only can be contacted by special researcher.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-10-13
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