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新冠肺炎大流行期间,正念对COVID-19患者的影响:一项随机对照试验
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注册号:

Registration number:

ChiCTR2100053822 

最近更新日期:

Date of Last Refreshed on:

2021-11-30 

注册时间:

Date of Registration:

2021-11-30 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新冠肺炎大流行期间,正念对COVID-19患者的影响:一项随机对照试验 

Public title:

Mindfulness Effects in COVID-19 Patients During the Coronavirus Disease 2019 (COVID-19) Pandemic: A Randomized Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新冠肺炎大流行期间,正念对COVID-19患者的影响:一项随机对照试验 

Scientific title:

Mindfulness Effects in COVID-19 Patients During the Coronavirus Disease 2019 (COVID-19) Pandemic: A Randomized Controlled Trial 

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:

刘欣怡 

研究负责人:

祝娉婷 

Applicant:

Xinyi Liu 

Study leader:

Pingting Zhu 

申请注册联系人电话:

Applicant telephone:

19895320357 

研究负责人电话:

Study leader's telephone:

+8613773566199 

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:

liuxinyi7012@163.com 

研究负责人电子邮件:

Study leader's E-mail:

ptzhu@yzu.edu.cn 

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:

江苏省扬州市邗江区江阳中路136号 

研究负责人通讯地址:

江苏省扬州市邗江区江阳中路136号 

Applicant address:

136 Jiangyang Middle Road, Hanjiang District, Yangzhou City, Jiangsu Province, China  

Study leader's address:

136 Jiangyang Middle Road, Hanjiang District, Yangzhou City, Jiangsu Province, 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:

扬州大学 

Applicant's institution:

Yangzhou 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:

YZUHL2021017 

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:

扬州大学护理学院伦理委员会 

Name of the ethic committee:

Ethics Committee, School of Nursing, Yangzhou University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-08-04 

伦理委员会联系人:

丁平俊 

Contact Name of the ethic committee:

Pingjun Ding 

伦理委员会联系地址:

江苏省扬州市邗江区江阳中路136号 

Contact Address of the ethic committee:

136 Jiangyang Middle Road, Hanjiang District, Yangzhou City, Jiangsu Province, 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:

扬州大学 

Primary sponsor:

Yangzhou University 

研究实施负责(组长)单位地址:

江苏省扬州市邗江区江阳中路136号 

Primary sponsor's address:

136 Jiangyang Middle Road, Hanjiang District, Yangzhou City, Jiangsu Province, 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):

江苏

市(区县):

扬州

Country:

China

Province:

Jiangsu

City:

Yangzhou

单位(医院):

扬州大学

具体地址:

江苏省扬州市邗江区江阳中路136号

Institution
hospital:

Yangzhou University

Address:

136 Jiangyang Middle Road, Hanjiang District, Yangzhou City, Jiangsu Province, China

经费或物资来源:

江苏省科研创新项目 

Source(s) of funding:

Postgraduate Research & Practice Innovation Program of Jiangsu Province 

研究疾病:

新型冠状病毒性肺炎(COVID-19) 

Target disease:

novel coronavirus pneumonia 

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:

I期临床试验 

Study phase:

研究目的:

探究正念减压疗法对COVID-19患者康复期心理状态的干预效果。 

Objectives of Study:

To explore the intervention effect of MBSR on the mental state of COVID-19 patients during convalescence. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1) 符合严重 COVID-19的关键诊断标准; (2) 年龄在 20 至 80 岁之间,为男性或女性; (3) 病情稳定,在干预中有意识和合作精神; (4) 自愿参加试验并签署知情同意书; (5) 承诺不执行其他锻炼计划。 

Inclusion criteria

(1) meet the critical diagnosis criteria for severe COVID-19, (2) are aged between 20 and 80?years and are male or female, (3) have a stable condition and are conscious and cooperative in the examination, (4) volunteer to join the trial and sign the informed consent form, and (5) promise not to perform other exercise programs. 

排除标准:

(1)患有慢性阻塞性肺病、阻塞性肺病、冠心病、高血压等其他严重基础性疾病并发症的患者; (2)严重精神病患者; (3)认知功能障碍患者,不能了解试验过程和康复内容的; (4)需要机械通气的呼吸衰竭患者或者需要重症监护室监测和治疗的休克、合并器官衰竭患者; (5)孕妇、哺乳期妇女; (6) 在试验期间参加其他形式的锻炼的患者。 

Exclusion criteria:

Those who meet one of the following conditions will be removed: (1) patients with complications of other serious underlying diseases, such as chronic obstructive pulmonary disease, obstructive pulmonary disease, coronary heart disease, and hypertension; (2) patients with serious mental illness; (3) patients with cognitive dysfunction who are unable to understand the trial process and rehabilitation content; (4) patients with respiratory failure who require mechanical ventilation or patients with shock or combined organ failure requiring intensive care unit (ICU) monitoring and treatment; (5) pregnant or lactating women; and (6) patients who participate in other forms of exercise during the trial. 

研究实施时间:

Study execute time:

From2021-10-16To 2022-01-31 

征募观察对象时间:

Recruiting time:

From2021-10-16To 2022-01-16 

干预措施:

Interventions:

组别:

干预组

样本量:

33

Group:

Intervention group

Sample size:

干预措施:

正念减压

干预措施代码:

Intervention:

MBSR

Intervention code:

组别:

对照组

样本量:

33

Group:

Control group

Sample size:

干预措施:

常规护理

干预措施代码:

Intervention:

Routine care

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

扬州 

Country:

China 

Province:

Jiangsu 

City:

Yanghzou 

单位(医院):

扬州大学附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

Affiliated Hospital of Yangzhou University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

心理弹性

指标类型:

主要指标 

Outcome:

Resilience

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病感知

指标类型:

次要指标 

Outcome:

Illness Perception

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 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):

本研究采用随机数字法分为干预组和对照组。按照COVID-19患者入院的先后顺序,按随机数字表对其进行分组。

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

This study was divided into intervention group and control group by random number method. Patients with COVID-19 were grouped in a random number table according to the order in which they were admitted to the hospital.

盲法:

Blinding:

是否共享原始数据:

IPD sharing

是Yes

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):

暂无

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

None

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:

问卷收集

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

Collecting the questionnaire

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-11-30
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