今天是:2020-04-08 星期三

基于应对方式的术前健康教育在经皮冠状动脉介入治疗患者中的应用研究
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注册号:

Registration number:

ChiCTR2000031261 

最近更新日期:

Date of Last Refreshed on:

2020-03-29 

注册时间:

Date of Registration:

2020-03-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于应对方式的术前健康教育在经皮冠状动脉介入治疗患者中的应用研究 

Public title:

Research on the Preoperative Health Education of Percutaneous Coronary Intervention Based on Coping Style 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于应对方式构建冠心病患者健康教育模式的研究与实践 

Scientific title:

Research on the Health Education Model of Coronary Heart Disease Based on Coping Style 

研究课题代号(代码):

Study subject ID:

[2018FE001(-218)] 

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:

卓俟岐 

研究负责人:

马芳 

Applicant:

Zhuo Qiqi 

Study leader:

Ma Fang 

申请注册联系人电话:

Applicant telephone:

+86 17723723307 

研究负责人电话:

Study leader's telephone:

+86 15925189957 

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:

972559720@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

rebeccamalei@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:

云南省昆明市西昌路295号 

研究负责人通讯地址:

云南省昆明市西昌路295号 

Applicant address:

295 Xichang Road, Kunming, China 

Study leader's address:

295 Xichang Road, Kunming, China 

申请注册联系人邮政编码:

Applicant postcode:

650032 

研究负责人邮政编码:

Study leader's postcode:

650032 

申请人所在单位:

昆明医科大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Kunming 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:

(2019)伦审L第26号 

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:

昆明医科大学第一附属医院伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of First Affiliated Hospital of Kunming Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-31 

伦理委员会联系人:

王婷 

Contact Name of the ethic committee:

Wang Ting 

伦理委员会联系地址:

云南昆明西昌路295号 

Contact Address of the ethic committee:

295 Xichang Road, Kunming, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0871-65328584 

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:

昆明医科大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Kunming Medical University 

研究实施负责(组长)单位地址:

云南省昆明市西昌路295号 

Primary sponsor's address:

295 Xichang Road, Kunming, 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):

云南

市(区县):

昆明

Country:

China

Province:

Yunnan

City:

Kunming

单位(医院):

昆明医科大学第一附属医院

具体地址:

西昌路295号

Institution
hospital:

The First Affiliated Hospital of Kunming Medical University

Address:

295 Xichang Road

经费或物资来源:

云南省科技厅、昆明医科大学联合基金 

Source(s) of funding:

Priority Union Foundation of Yunnan Provincial Science and Technology Department and Kunming Medical University  

研究疾病:

冠心病 

Target disease:

coronary heart disease 

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:

将基于应对方式的健康教育模式应用于经皮冠状动脉介入治疗术前患者,并对该健康教育模式进行评价。 

Objectives of Study:

The health education model based on coping style was applied to patients before percutaneous coronary intervention and evaluated the effctiveness. 

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:

自愿参与研究;第一次做经皮冠状动脉介入治疗手术;年龄大于18岁,且有正常交流和读写能力。 

Inclusion criteria

Voluntary participation; first Percutaneous coronary intervention surgical patients; over 18 years old, Having normal communication and literacy skills. 

排除标准:

正在参与其他研究;急诊经皮冠状动脉介入治疗;疾病严重或有其他严重共病;有精神疾病患者排除。 

Exclusion criteria:

Participate in other study; emergency percutaneous coronary intervention; have seriously illness, other major comorbidity or psychiatric disease. 

研究实施时间:

Study execute time:

From2020-04-01To 2020-09-30 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

experimental group

Sample size:

干预措施:

基于应对方式的健康教育

干预措施代码:

M/B

Intervention:

health education based on coping style

Intervention code:

组别:

对照组

样本量:

100

Group:

control group

Sample size:

干预措施:

常规健康教育

干预措施代码:

G

Intervention:

general health education

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

云南 

市(区县):

昆明 

Country:

China 

Province:

Yunnan 

City:

Kunming 

单位(医院):

昆明医科大学第一附属医院 

单位级别:

三级 

Institution
hospital:

The First Affiliated Hospital of Kunming Medical University  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

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:

健康教育前一小时和手术前一小时

测量方法:

焦虑自评量表

Measure time point of outcome:

one hour before health education and one hour before surgery

Measure method:

self-rating anxiety scale

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:

健康教育前一小时和手术前一小时

测量方法:

抑郁自评量表

Measure time point of outcome:

one hour before health education and one hour before surgery

Measure method:

self-rating depression scale

指标中文名:

心率

指标类型:

次要指标 

Outcome:

heart rate

Type:

Secondary indicator 

测量时间点:

健康教育前一小时和手术前一小时

测量方法:

听诊器

Measure time point of outcome:

one hour before health

Measure method:

echometer

指标中文名:

血压

指标类型:

次要指标 

Outcome:

blood pressure

Type:

Secondary indicator 

测量时间点:

健康教育前一小时和手术前一小时

测量方法:

水银血压计

Measure time point of outcome:

one hour before health

Measure method:

riva-rocci sphygmomanometer

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:

健康教育前一小时和手术前一小时

测量方法:

自制健康教育满意度问卷

Measure time point of outcome:

one hour before health

Measure method:

Self - made health education satisfaction questionnaire

指标中文名:

住院天数

指标类型:

次要指标 

Outcome:

length of stay

Type:

Secondary indicator 

测量时间点:

入院到出院

测量方法:

病例

Measure time point of outcome:

admission to discharge

Measure method:

case

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 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):

随机区组法:一名非本课题组成员的统计学领域专家用随机区组法对纳入样本进行随机分组,产生随机序列

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

Randomized block method: an expert in statistics who is not a member of the research group randomly groups the samples to generate random sequence

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

原始数据上传至中国临床试验注册中心的ResMan原始数据共享平台

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

The original data was uploaded to the ResMan original data sharing platform of the China clinical trial registry center

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:

Epidata软件

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

Epidata software package

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-03-26
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