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Construction of colonoscopy nursing sensitivity quality index system based on structure-process-result model
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注册号:

Registration number:

ChiCTR2100054110 

最近更新日期:

Date of Last Refreshed on:

2022-06-07 

注册时间:

Date of Registration:

2021-12-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于“结构-过程-结果”模型的结肠镜检查护理敏感性质量指标体系构建 

Public title:

Construction of colonoscopy nursing sensitivity quality index system based on structure-process-result model 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于“结构-过程-结果”模型的结肠镜检查护理敏感性质量指标体系构建 

Scientific title:

Construction of colonoscopy nursing sensitivity quality index system based on structure-process-result model 

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:

蔡文文 

研究负责人:

阮伟清 

Applicant:

Cai Wenwen 

Study leader:

Ruan Weiqing 

申请注册联系人电话:

Applicant telephone:

+86 13616765010 

研究负责人电话:

Study leader's telephone:

+86 13533399913 

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:

caiww85@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jamela@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:

广东广州市白云区京溪街道广州大道北1838号  

研究负责人通讯地址:

广东广州市白云区京溪街道广州大道北1838号  

Applicant address:

1838 Guangzhou Avenue North, Jingxi Street, Baiyun District, Guangzhou, Guangdong 

Study leader's address:

1838 Guangzhou Avenue North, Jingxi Street, Baiyun District, Guangzhou, Guangdong 

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:

南方医科大学 

Applicant's institution:

Southern 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:

NFEC-2021-378 

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:

南方医科大学南方医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Southern Hospital of Southern Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2021-11-18 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

广州市白云区京溪街道广州大道北1838号  

Contact Address of the ethic committee:

1838 Guangzhou Avenue North, Jingxi Street, Baiyun District, Guangzhou, Guangdong 

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:

南方医科大学南方医院 

Primary sponsor:

Southern Hospital of Southern Medical University 

研究实施负责(组长)单位地址:

广东广州市白云区京溪街道广州大道北1838号  

Primary sponsor's address:

1838 Guangzhou Avenue North, Jingxi Street, Baiyun District, Guangzhou, Guangdong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医科大学南方医院

具体地址:

白云区京溪街道广州大道北1838号

Institution
hospital:

Southern Hospital of Southern Medical University

Address:

1838 Guangzhou Avenue North, Jingxi Street, Baiyun District

经费或物资来源:

无 

Source(s) of funding:

N/A 

研究疾病:

无 

Target disease:

N/A 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

主要目的:建立科学、严谨、可行、适宜的结肠镜就检患者的护理指标,预期结合护理结局和敏感指标形成完整的护理敏感性质量指标体系,为患者就检 安全与满意提供保障。次要目的:优化结肠镜检查工作流程,提升患者的就诊满意度。 

Objectives of Study:

Main purpose: To establish scientific, rigorous, feasible and appropriate nursing indicators for patients undergoing colonoscopy examination, and to form a complete nursing sensitivity quality index system based on nursing outcomes and sensitive indicators, so as to provide guarantee for the safety and satisfaction of patients undergoing examination. Secondary objective: To optimize colonoscopy workflow and improve patient satisfaction. 

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.自愿签署知情同意书; 2.行结肠镜检查患者; 3.年龄≥18 岁,性别不限; 4.无精神异常,有一定的阅读及表达能力; 5.在内镜室有 5 年以上工作经验。 

Inclusion criteria

1. Voluntarily sign the informed consent; 2. Patients undergoing colonoscopy; 3. >= 18 years old, gender is not limited; 4. No mental disorder, with certain reading and expression skills; 5. Have more than 5 years working experience in endoscopy room. 

排除标准:

1.结肠镜就检者排除标准: 经研究者判断认为不适合参与本研究; 访谈过程中因事务中断或自愿退出者;出现结肠镜检查严重并发症者; 2.内镜室医护人员排除标准: 经研究者判断认为不适合参与本研究;访谈过程中因事务中断或自愿退出者。 

Exclusion criteria:

1. Exclusion criteria for colonoscopy examinees: Those who are judged by the investigator to be unsuitable to participate in this study; those who were interrupted or voluntarily withdrawn during the interview process; those who had serious complications of colonoscopy; 2. Exclusion criteria for medical staff in the endoscopy room: Those who were judged by the researchers to be unsuitable to participate in this study; those who were interrupted or voluntarily withdrawn during the interview process. 

研究实施时间:

Study execute time:

From2021-12-01To 2023-03-31 

征募观察对象时间:

Recruiting time:

From2021-12-01To 2022-01-31 

干预措施:

Interventions:

组别:

连续入组

样本量:

30

Group:

case series

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医科大学南方医院 

单位级别:

三级甲等 

Institution
hospital:

Southern Hospital of Southern Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

结肠镜检

指标类型:

主要指标 

Outcome:

colonoscopy

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:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 18 years
最大 Max age 75 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):

N/A

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

N/A

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

邮箱联系项目联系人

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

Email Project Contact

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:

病例记录表(Case Record Form, CRF)

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

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-09
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