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重症监护日记预防ICU患者创伤后应激障碍的有效性和安全性的随机对照研究
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注册号:

Registration number:

ChiCTR-IOR-16009109 

最近更新日期:

Date of Last Refreshed on:

2016-08-28 

注册时间:

Date of Registration:

2016-08-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

重症监护日记预防ICU患者创伤后应激障碍的有效性和安全性的随机对照研究 

Public title:

Evaluation of the effect and safety of intensive care diaries on preventing post-traumatic stress disorder in ICU survivors a randomized controlled trials. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

ICU患者创伤后应激障碍的预测因素及睡眠结构的研究 

Scientific title:

Study on precipitants of post-traumatic stress disorder and the sleep structures in ICU survivors 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(81201500) 

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:

王烁 

研究负责人:

胡蓉芳 

Applicant:

Shuo Wang 

Study leader:

Rongfang Hu 

申请注册联系人电话:

Applicant telephone:

+86 15959065381 

研究负责人电话:

Study leader's telephone:

0591-22862526 

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:

wsfjmu2010@foxmail.com 

研究负责人电子邮件:

Study leader's E-mail:

hulu2886@sina.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:

福建省福州市交通路88号 

研究负责人通讯地址:

福州市闽侯县上街镇学园路1号福建医科大学护理学院妇儿教研室 

Applicant address:

88 Jiaotong Road, Taijiang District, Fuzhou, China 

Study leader's address:

1 Xueyuan Road, Shangjie Town, Minhou County, Fuzhou, Fujian, China 

申请注册联系人邮政编码:

Applicant postcode:

350004 

研究负责人邮政编码:

Study leader's postcode:

350004 

申请人所在单位:

福建医科大学 

Applicant's institution:

Fujian 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:

2012-58 

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:

福建医科大学生物医学研究伦理审查委员会 

Name of the ethic committee:

biological and medical research Ethics committee of Fujian Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-03-08 

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:

福建医科大学护理学院 

Primary sponsor:

School of Nursing, Fujian Medical University 

研究实施负责(组长)单位地址:

福州市闽侯县上街镇学园路1号福建医科大学护理学院妇儿教研室 

Primary sponsor's address:

1 Xueyuan Road, Shangjie Town, Minhou County, Fuzhou, Fujian, 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):

福建

市(区县):

福州

Country:

China

Province:

Fujian

City:

fuzhou

单位(医院):

福建省立医院

具体地址:

福建省福州市东街134号

Institution
hospital:

Fujian provincial hospital

Address:

134 Shidong Streat, Fuzhou, Fujian, China

国家:

中国

省(直辖市):

福建

市(区县):

福州

Country:

China

Province:

fujian

City:

fuzhou

单位(医院):

福建医科大学附属协和医院

具体地址:

福州市鼓楼区新权路29号

Institution
hospital:

Union Hospital of Fujian Medical University

Address:

29 Xinquan Road, Fuzhou, Fujian, China

经费或物资来源:

国家自然科学基金(81201500) 

Source(s) of funding:

Natural Science Foundation of China (81201500) 

研究疾病:

创伤后应激障碍 

Target disease:

post-traumatic stress disorder 

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:

其它 

Study phase:

N/A 

研究目的:

探索ICU日记法减轻ICU经历后压力相关症状,减少PTSD发生的有效性和安全性。 

Objectives of Study:

To evaluate the effect and safety of ICU diary on stress-related disorder and PTSD prevalence. 

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.研究对象为重症监护治疗患者,年龄≥18岁; 2.预计患者ICU住院时间≥24小时; 3.患者签署知情同意书,同意参与该临床试验。 

Inclusion criteria

1. patients in ICU, aged≥18 years old; 2. ICU length of stay ≥24 hours with prediction; 3. Informed consent and voluntary subjects. 

排除标准:

1.ICU住院时间<24小时 2.患者为孕产妇或烧伤患者; 3.患有颅脑疾病,或为颅脑术后患者; 4.因自杀或自伤入住ICU; 5.使用抗焦虑或抑郁药; 6.有精神疾病史; 7.患者病情严重或意识不清,无法配合相应的评估和检查。  

Exclusion criteria:

1. stay in ICU less than 24 hours; 2. pregnant, maternal and burn patients; 3. patients with cerebral disease and patients post cerebral operation; 4. patients had been admitted following a deliberate suicide attempt and were continuing to express suicidal ideation or intent; 5. using antianxiety drugs and antidepressant; 6. had pre-existing psychotic illness; 7. too confused to give informed consent. 

研究实施时间:

Study execute time:

From2016-09-01To 2017-06-30 

征募观察对象时间:

Recruiting time:

From2016-09-01To 2016-03-30 

干预措施:

Interventions:

组别:

试验组

样本量:

62

Group:

intervention group

Sample size:

干预措施:

ICU日记

干预措施代码:

Intervention:

ICU diary

Intervention code:

组别:

对照组

样本量:

62

Group:

control group

Sample size:

干预措施:

常规护理

干预措施代码:

Intervention:

general care

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

fujian 

City:

fuzhou 

单位(医院):

福建省立医院 

单位级别:

三级甲等医院 

Institution
hospital:

Fujian provincial hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

fujian 

City:

fuzhou 

单位(医院):

福建医科大学附属协和医院 

单位级别:

三级甲等医院 

Institution
hospital:

Union Hospital of Fujian Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

创伤后应激障碍

指标类型:

主要指标 

Outcome:

post-traumatic 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:

睡眠质量

指标类型:

主要指标 

Outcome:

sleep quality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑抑郁

指标类型:

主要指标 

Outcome:

anxiety and 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:

ICU日记副作用

指标类型:

次要指标 

Outcome:

adverse effect

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

健康相关生命质量

指标类型:

次要指标 

Outcome:

health-related quality of life

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU相关记忆

指标类型:

主要指标 

Outcome:

ICU memory

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

满意度

指标类型:

次要指标 

Outcome:

satisfaction

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:

唾液

组织:

Sample Name:

Saliva

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 years
最大 Max age 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):

研究负责人(不参与试验)通过随机软件产生随机序列(共124个数字)。

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

Randomly divide the participants into intervention group and control group with a random number software by the study leader.

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

福建医科大学

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

Fujian medical university

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:

福建医科大学

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

Fujian medical university

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-08-28
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