今天是:2020-08-11 星期二

儿童牙科焦虑和不合作行为管理整群随机干预对照研究
下载XML文档

注册号:

Registration number:

ChiCTR2000028878 

最近更新日期:

Date of Last Refreshed on:

2020-01-05 

注册时间:

Date of Registration:

2020-01-05 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

儿童牙科焦虑和不合作行为管理整群随机干预对照研究 

Public title:

Intervention for children's dental anxiety and dental behavior management problems:a cluster randomized trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

儿童牙科焦虑体验式学习干预:整群随机对照研究 

Scientific title:

Experiential learning intervention for children's dental anxiety: a cluster randomized trial 

研究课题代号(代码):

Study subject ID:

JCYJ20170306155909623 

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:

朱闵敏 

研究负责人:

李雪琦 

Applicant:

Minmin Zhu 

Study leader:

Xueqi Li 

申请注册联系人电话:

Applicant telephone:

+86 13923442693 

研究负责人电话:

Study leader's telephone:

+86 13688809379 

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:

zhuminmin1982@163.com 

研究负责人电子邮件:

Study leader's E-mail:

756296691@qq.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:

深圳市南山区华明路7号 

研究负责人通讯地址:

深圳市南山区蛇口湾厦路1号 

Applicant address:

7 Huaming Road, Nanshan District, Shenzhen, Guangdong, China 

Study leader's address:

1 Wanxia Road, Shekou, Nanshan District, Shenzhen, Guangdong, 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:

深圳市南山区慢性病防治院 

Applicant's institution:

Shenzhen Nanshan Center for Chronic Disease Control 

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:

2017 

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:

深圳市南山区妇幼保健院伦理委员会 

Name of the ethic committee:

Ethics Committee of the Shenzhen Nanshan Maternal and Child Health Care Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-02-27 

伦理委员会联系人:

刘华 

Contact Name of the ethic committee:

Hua Liu 

伦理委员会联系地址:

深圳市南山区蛇口湾厦路1号 

Contact Address of the ethic committee:

1 Wanxia Road, Shekou, Nanshan District, Shenzhen, Guangdong, 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:

深圳市南山区妇幼保健院 

Primary sponsor:

Shenzhen Nanshan Maternal and Child Health Care Hospital 

研究实施负责(组长)单位地址:

深圳市南山区蛇口湾厦路1号 

Primary sponsor's address:

1 Wanxia Road, Shekou, Nanshan District, Shenzhen, Guangdong, 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):

广东省

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市南山区妇幼保健院

具体地址:

深圳市南山区蛇口湾厦路1号

Institution
hospital:

Shenzhen Nanshan Maternal and Child Health Care Hospital

Address:

1 Wanxia Road, Shekou, Nanshan District, Shenzhen

经费或物资来源:

深圳市科技创新委员会科技计划研究项目No. JCYJ20170306155909623 

Source(s) of funding:

Grant for Scientific and Technology Research (No. JCYJ20170306155909623) from the Bureau of Science and Technology Innovation Commission of Shenzhen City 

研究疾病:

牙科焦虑 

Target disease:

dental anxiety 

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:

研究就诊前对儿童开展体验式牙科健康教育能否减少儿童牙科焦虑及降低儿童牙科不合作行为的发生 

Objectives of Study:

To evaluate whether EL intervention can reduce children's dental anxiety and dental behavior management problems 

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)2018年南山区公立小学2年级儿童; (2)家长知情同意 

Inclusion criteria

1. The participants were children at the second grade of primary schools in September 2018, at the Nanshan District of the city of Shenzhen, China; 2. Informed consents signed by their parents.  

排除标准:

(1)已有牙科就诊经历; (2)拒绝参与者; (3)患有精神疾病 

Exclusion criteria:

1. Children who already had a dental visit; 2. Refused to participate; 3. Have a mental illness. 

研究实施时间:

Study execute time:

From2017-07-01To 2020-06-30 

征募观察对象时间:

Recruiting time:

From2018-09-01To 2018-09-30 

干预措施:

Interventions:

组别:

干预组

样本量:

480

Group:

Intervention group

Sample size:

干预措施:

体验式学习

干预措施代码:

Intervention:

Experiential Learning

Intervention code:

组别:

对照组

样本量:

480

Group:

Control group

Sample size:

干预措施:

常规健康教育

干预措施代码:

Intervention:

health education

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

深圳市南山区妇幼保健院 

单位级别:

二甲专科医院 

Institution
hospital:

Shenzhen Nanshan Maternal and Child Health Care Hospital  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

牙科焦虑患病率

指标类型:

主要指标 

Outcome:

Prevalence of dental anxiety

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

次要指标 

Outcome:

Pluse rate

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 7 years
最大 Max age 8 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):

多阶段整群随机抽样,设计者使用随机数据表,从南山区公立小学中随机抽取6所(小学二年级班级>=4个班级)学校,再随机抽取4个班级。

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

We first used a table of random digits to select six primary schools in Nanshan that had at least four or more second grade classes, and then random selected four second grade classes in each of the six schools.

盲法:

Open label

Blinding:

Open label

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

excel表

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

excel table

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:

参与者记录表,ResMan

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

Participant Record Form,ResMan

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-01-05
返回列表