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需求导向型的信息支持对高龄经产妇产前焦虑的干预性研究
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注册号:

Registration number:

ChiCTR2100047552 

最近更新日期:

Date of Last Refreshed on:

2022-02-20 

注册时间:

Date of Registration:

2021-06-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

需求导向型的信息支持对高龄经产妇产前焦虑的干预性研究 

Public title:

Demand-oriented information supports intervention studies on antenatal anxiety in older women 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

需求导向型的信息支持对高龄经产妇产前焦虑的干预性研究 

Scientific title:

Demand-oriented information supports intervention studies on antenatal anxiety in older women 

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:

黄粲然 

研究负责人:

欧阳艳琼 

Applicant:

Huang Canran 

Study leader:

Ouyang Yanqiong 

申请注册联系人电话:

Applicant telephone:

+86 18252058200 

研究负责人电话:

Study leader's telephone:

+86 13797037255 

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:

hcr9794@163.com 

研究负责人电子邮件:

Study leader's E-mail:

ouyangyq@whu.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:

湖北省武汉市武昌区东湖路115号 

研究负责人通讯地址:

湖北省武汉市武昌区东湖路115号 

Applicant address:

115 Donghu Road, Wuchang District, Wuhan, Hubei 

Study leader's address:

115 Donghu Road, Wuchang District, Wuhan, Hubei 

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:

武汉大学健康学院 

Applicant's institution:

Wuhan University School of Health Sciences 

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:

2020YF0083 

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:

武汉大学医学院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee, School of Medicine, Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

未说明 

Contact Name of the ethic committee:

Not stated 

伦理委员会联系地址:

湖北省武汉市武昌区东湖路115号 

Contact Address of the ethic committee:

115 Donghu Road, Wuchang District, Wuhan, Hubei 

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:

武汉大学健康学院 

Primary sponsor:

Wuhan University School of Health Sciences 

研究实施负责(组长)单位地址:

湖北省武汉市武昌区东湖路115号 

Primary sponsor's address:

115 Donghu Road, Wuchang District, Wuhan, Hubei 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学健康学院

具体地址:

武昌区东湖路115号

Institution
hospital:

Wuhan University School of Health Sciences

Address:

115 Donghu Road, Wuchang District

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

围产期心理健康疾病管理 

Target disease:

Management of perinatal mental health disorders 

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:

评价需求导向型信息支持对高龄经产妇焦虑的干预效果。 

Objectives of Study:

To evaluate the intervention effect of demand-oriented information support on senile maternal anxiety. 

药物成份或治疗方案详述:

对照组接受产科门诊常规护理,干预组在接受常规门诊护理的基础上,给予为期4次的需求导向式信息支持。当前干预方案是通过系统的文献查阅、经过与五名妇幼保健专家的讨论和五名高龄经产妇的沟通,初步制定了针对高龄经产妇知识需求的产前干预方案方案。随后,我们再将该项干预方案提交给一个专家小组进行协商和审查,该专家小组包括三名在产科工作了至少十年的医疗保健专业人员(产科医生、助产士和护士),以及两名妇幼护理学领域教授,在经过三次修订后,最终形成了四个主题:1.产前焦虑基本知识;2.孕产妇年龄相关母婴风险知识;3.心理放松策略知识;4.孕期用药知识。 

Description for medicine or protocol of treatment in detail:

The control group received routine obstetrical outpatient care, while the intervention group received routine outpatient care and demand-oriented information support for 4 times. The current intervention program is based on systematic literature review, discussion with five maternal and child health experts and communication with five elderly parturients, and preliminarily formulated the antenatal intervention program aiming at the knowledge needs of elderly parturients. Again then, we will submit the intervention plans for a panel of experts to consultation and review, the panel, including three in obstetric for at least ten years of health care professionals (obstetrician, midwives and nurses), and two women's and children's nursing field professor, after revised three times and finally formed the four themes: 1.Basic knowledge of prenatal anxiety; 2.Knowledge on maternal age-related maternal and fetal risks; 3.Knowledge on psychological relaxation strategies; 4.Knowledge on medication uses during pregnancy.  

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.年龄 >= 35 岁 ; 2.妊娠满28周不足30周; 3.单胎妊娠; 4.在本院规律产检; 5.能够有效阅读、书写和沟通交流; 6.获取知情同意书。 

Inclusion criteria

1.Aged 35 years or older; 2.At 28~30 weeks of gestation; 3.Singleton pregnancy; 4.Received prenatal care regularly; 5.Able to read, write and communicate effectively; 6.Obtained written informed consent. 

排除标准:

1.伴有妊娠合并症或并发症、急性感染或严重的脏器功能损伤、夫妻任意一方有遗传病史者; 2.早产妇女; 3.干预期间家庭发生重大事故者(如,离婚,伴侣的重大疾病或死亡)。 

Exclusion criteria:

1.Pregnancy complications or complications, acute infection or serious organ function injury, and genetic history of either spouse; 2.Patients with preterm infants; 3.Major family accidents (e.g., divorce, major illness or death of a partner) occurred during the intervention. 

研究实施时间:

Study execute time:

From2021-03-01To 2021-10-01 

征募观察对象时间:

Recruiting time:

From2021-07-01To 2021-09-01 

干预措施:

Interventions:

组别:

干预组

样本量:

45

Group:

Intervention group

Sample size:

干预措施:

在接受常规门诊护理的基础上,给予为期 4 次的需求导向式信息支持

干预措施代码:

Intervention:

Four sessions of needs-oriented information support were provided in addition to routine outpatient care

Intervention code:

组别:

对照组

样本量:

45

Group:

Control group

Sample size:

干预措施:

产科门诊常规护理

干预措施代码:

Intervention:

Routine obstetric outpatient care

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉大学中南医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

妊娠焦虑

指标类型:

主要指标 

Outcome:

pregnancy anxiety

Type:

Primary indicator 

测量时间点:

干预前后

测量方法:

使用妊娠相关焦虑量表

Measure time point of outcome:

before and after the intervention

Measure method:

by using Pregnancy-related Anxiety Questionnaire

指标中文名:

血压

指标类型:

附加指标 

Outcome:

blood pressure

Type:

Additional indicator 

测量时间点:

干预前后

测量方法:

电子血压计

Measure time point of outcome:

before and after the intervention

Measure method:

electronic sphygmomanometer

指标中文名:

心率

指标类型:

附加指标 

Outcome:

heart rate

Type:

Additional indicator 

测量时间点:

干预前后

测量方法:

电子血压计

Measure time point of outcome:

before and after the intervention

Measure method:

electronic sphygmomanometer

指标中文名:

胎心无负荷试验

指标类型:

附加指标 

Outcome:

fetal heart no load test

Type:

Additional indicator 

测量时间点:

干预前后

测量方法:

多普勒胎心监护仪

Measure time point of outcome:

before and after the intervention

Measure method:

Doppler heart rate monitor

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

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 35 years
最大 Max age years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

将符合纳排标准的孕妇以来院产检顺序1,2,3……89,90依次编号,再将这90个号码通过使用随机数字表法分为对照组和干预组,两组各45名。这一过程由研究助手申泉完成。

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

The pregnant women who meet the criteria will come to the hospital in the order of 1,2,3... 89,90 were numbered in sequence, and then the 90 numbers were divided into the control group and the intervention group by using random number table method, with 45 people in each group.

盲法:

未说明

Blinding:

No stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否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):

完成数据收集后将考虑公开。 请阅读网页注册指南中关于 原始数据共享 的内容。

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

Disclosure will be considered after data collection is completed.

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:

由研究助手通过采用问卷的方式现场收集。

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

It was collected on-site by a research assistant using questionnaires.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2021-06-20
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