ChiCTR2400088183 版本V1.0 版本创建时间2024/08/13 10:49:36 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400088183 

最近更新日期：

Date of Last Refreshed on：

2024-08-13 10:49:32 

注册时间：

Date of Registration：

2024-08-13 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

生物养育法对母乳喂养和母婴依恋的影响

Public title：

Effect of biological nurturing on breastfeeding and maternal postnatal attachment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

生物养育法对母乳喂养和母婴依恋的影响

Scientific title：

Effects of biological nurturing on breastfeeding and maternal postnatal attachment

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：

胡隆怡 

研究负责人：

胡隆怡 

Applicant：

Hu Long-yi 

Study leader：

Hu Long-yi 

申请注册联系人电话：

Applicant telephone：

+86 152 1101 0740

研究负责人电话：

Study leader's telephone：

+86 152 1101 0740

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：

227811015@csu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

227811015@csu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

Central South University Xiangya Nursing School Department of Clinical Nursing

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：

湖南省长沙市岳麓区桐梓坡路172号

研究负责人通讯地址：

湖南省长沙市岳麓区桐梓坡路172号

Applicant address：

172 Tong Zi Po Rd.,?Yuelu District ,Changsha, Hunan,?CN 172 Tong Zi Po Rd., Yuelu District Changsha, Hunan, 410013

Study leader's address：

172 Tong Zi Po Rd.,?Yuelu District ,Changsha, Hunan,?CN 172 Tong Zi Po Rd., Yuelu District Changsha, Hunan, 410013

申请注册联系人邮政编码：

Applicant postcode：

410013

研究负责人邮政编码：

Study leader's postcode：

410013

申请人所在单位：

中南大学湘雅护理学院

Applicant's institution：

Xiangya Nursing School Of Central South University

研究负责人所在单位：

中南大学湘雅护理学院

Affiliation of the Leader：

Xiangya Nursing School Of Central South University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

E2023135

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：

中南大学护理学院护理与行为医学研究伦理审查委员会

Name of the ethic committee：

Nursing and Behavioral Medicine Research Ethics Review Committee, College of Nursing, CSUN

伦理委员会批准日期：

Date of approved by ethic committee：

2023-06-12 00:00:00

伦理委员会联系人：

杨敏

Contact Name of the ethic committee：

Yang Min

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路172号

Contact Address of the ethic committee：

172 Tong Zi Po Rd.,?Yuelu District ,Changsha, Hunan,?CN

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 180 7318 5501

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yangminzhu@csu.edu.cn

研究实施负责（组长）单位：

中南大学湘雅护理学院

Primary sponsor：

Xiangya Nursing School Of Central South University

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区桐梓坡路172号

Primary sponsor's address：

172 Tong Zi Po Rd.,?Yuelu District ,Changsha, Hunan,?CN

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

hunan

City：

Changsha

单位(医院)：

中南大学湘雅护理学院

具体地址：

湖南省长沙市岳麓区桐梓坡路172号

Institution
hospital：

Xiangya Nursing School Of Central South University

Address：

172 Tong Zi Po Rd.Yuelu District ,Changsha, Hunan,?CN

经费或物资来源：

自费

Source(s) of funding：

self-financing

Target disease：

breast feeding

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

（1）探究不同哺乳姿势（传统喂养姿势和生物养育法）对母亲体位舒适度和新生儿反射的影响； （2）探究不同哺乳姿势（传统喂养姿势和生物养育法）对母婴依恋关系的影响。  

Objectives of Study：

(1) To investigate the effects of different breastfeeding positions (traditional feeding position and biological nurturing) on mothers' postural comfort and neonatal reflexes; (2) To investigate the effects of different breastfeeding positions (traditional feeding positions and biological nurturing methods) on maternal postnatal attachment.

药物成份或治疗方案详述：

（1）基础护理支持 两组参与者均接受产后早期皮肤接触和母婴同室的基础护理，产后第一次哺乳时，由研究者本人根据分组结果对两组产妇分别进行母乳喂养知识指导，并协助产妇完成一次成功含接。在产妇住院期间，研究者在每天固定时间段对产妇姿势进行指导，直至产妇掌握对应姿势。产妇出院后3天均进行回访以保证产妇使用对应姿势进行哺乳，并追踪产后7天和42天产妇的喂养姿势。 两组分别建立一个微信群，由产科护士长和一名主管护士作为指导加入群聊。研究者每周在群内发布哺乳姿势及母乳喂养相关知识，相关知识参考《中国妈妈母乳喂养指导手册》[64]。内容除指导哺乳姿势不同以外，其他均相同。产妇在哺乳中遇到哺乳姿势或母乳喂养的问题可以在微信群中提出，由研究者及指导答疑，并鼓励产妇在微信群中交流母乳喂养心得。 （2）观察观察组喂养姿势 由研究者指导生物养育法哺乳姿势：母亲取向后倚靠的45°半躺位，使用被褥、枕头等支撑母亲腰背部，以母亲可以看到婴儿，且婴儿不会从母亲身上滑下为宜，初次指导衔乳时，婴儿只穿纸尿裤趴在母亲身上，等待其本能寻乳、含接、吸吮、吞咽。待婴儿能够成功衔乳后，母亲可根据自身情况适当调整姿势。 （3）对照组喂养姿势 由研究者指导哺乳姿势：根据WHO规定的标准喂养姿势教学：摇篮式、侧卧式、橄榄球式、交叉式，由产妇选择自己舒适的姿势。哺乳姿势要点:妈妈取对应姿势，使宝宝的头、颈、肩、臀在同一条水平直线上,宝宝身体面向妈妈的身体，脸面向妈妈的乳房，鼻尖对着乳头，等待宝宝张嘴到最大时送乳，使宝宝下巴贴在乳房上，含住乳头和大部分乳晕。  

Description for medicine or protocol of treatment in detail：

(1) Basic nursing support Participants in both groups received basic nursing care of early postnatal skin contact and mother-infant rooming-in, and at the time of the first postnatal breastfeeding, the researcher herself instructed the mothers of both groups on breastfeeding knowledge according to the results of grouping and assisted the mothers in completing a successful containment session. During the hospitalization period, the researcher instructed the mothers' postures at a fixed period of time every day until the mothers mastered the corresponding postures. A return visit was made 3 days after discharge to ensure that the mother was breastfeeding in the appropriate position, and the feeding positions of the mothers were tracked at 7 and 42 days postpartum. A WeChat group was set up in each group, with the head nurse of the maternity unit and a charge nurse joining the group chat as a guide. The researcher posted breastfeeding postures and breastfeeding-related knowledge in the group every week, which was referenced to the Breastfeeding Guidance Manual for Chinese Mothers [64]. The contents were the same except that the guidance on breastfeeding posture was different. Mothers who encountered problems with breastfeeding posture or breastfeeding during breastfeeding could raise them in the WeChat group, and the researcher and the guidance answered the questions and encouraged the mothers to exchange breastfeeding tips in the WeChat group. (2) Observe the feeding posture of the observation group The researcher instructed the biological method of breastfeeding posture: the mother took a 45° semi-reclining position leaning backward, using bedding, pillows, etc. to support the mother's waist and back, so that the mother can see the baby, and the baby will not slide down from the mother, the initial instruction of the breastfeeding, the baby only wearing a diaper lying on the mother, waiting for its instincts to find the breast, contain the connection, sucking, swallowing. After the infant was able to successfully breastfeed, the mother could adjust the posture according to her own situation. (3) Feeding posture of the control group Breastfeeding postures were instructed by the researcher: according to the standard feeding postures stipulated by WHO: cradle position, side-lying position, rugby ball position, cross position, and mothers chose their own comfortable positions. The main points of breastfeeding posture:The mother took the corresponding position, so that the baby's head, neck, shoulders and buttocks were in the same horizontal straight line, the baby's body facing the mother's body, face to the mother's breast, the tip of the nose to the nipple, and waited for the baby's mouth to open to the maximum to deliver the breast, so that the baby's chin was attached to the breast, and the nipple and most of the areola were contained. 

纳入标准：

纳入标准： （1）有母乳喂养意愿的产妇； （2）母亲年龄＞20岁； （3）37周≤婴儿胎龄＜41周，单胎； （4）自愿参与本研究且能够配合研究;

Inclusion criteria

Inclusion criteria: Mothers who (1) will to breastfeeding; (2) over 20 years old; (3) 37 - 41 weeks of gestation ;singleton; (4) have no breastfeeding experience; (5) Voluntary participation in this study and able to cooperate with the study

排除标准：

排除标准： （1）有哺乳禁忌症不能母乳喂养者； （2）有乳房相关疾病者； （3）因疾病导致母婴分离者； （4）其他愿意退出研究者。

Exclusion criteria：

Exclusion Criteria: (1) Those with contraindications to breastfeeding who cannot breastfeed; (2) Those with breast-related diseases; (3) Those who had mother-infant separation due to illness; (4) Others willing to withdraw from the study.

研究实施时间：

Study execute time：

从 From 2023-10-01 00:00:00至 To 2024-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-10-08 00:00:00 至 To 2024-01-01 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

40

Group：

comparison group

Sample size：

干预措施：

由研究者指导哺乳姿势：根据WHO规定的标准喂养姿势教学：摇篮式、侧卧式、橄榄球式、交叉式，由产妇选择自己舒适的姿势。

干预措施代码：

 0

Intervention：

Instruction on breastfeeding positions by the researcher: teaching based on the standard feeding positions prescribed by WHO: cradle, side-lying, rugby ball, and crossover, with the mother choosing the position she is comfortable in.

Intervention code：

组别：

观察组

样本量：

40

Group：

Observation Group

Sample size：

干预措施：

由研究者指导半躺式哺乳姿势：母亲取向后倚靠的45°半躺位，使用被褥、枕头等支撑母亲腰背部，以母亲可以看到婴儿，且婴儿不会从母亲身上滑下为宜，婴儿只穿纸尿裤趴在母亲身上，等待其本能寻乳、含接、吸吮、吞咽。

干预措施代码：

 1

Intervention：

The researcher instructed a semi-reclining breastfeeding position: a 45° semi-reclining position with the mother leaning backward, using bedding, pillows, etc., to support the mother's lower back, so that the mother could see the baby and the baby would not slide off the mother, and the baby would lie on the mother with only a diaper on and wait for his/her instincts to find the breast, take it in, suck it, and swallow it.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 长沙 

Country：

China 

Province：

hunan 

City：

Changsha 

单位(医院)：

中南大学湘雅三医院 

单位级别：

三甲 

Institution
hospital：

The third xiangya hospital of central south university

Level of the institution：

tertiary A

测量指标：

Outcomes：

指标中文名：

母婴依恋

指标类型：

主要指标

Outcome：

maternal postnatal attachment

Type：

Primary indicator

测量时间点：

干预前，产后，产后7天，产后42天

测量方法：

量表法

Measure time point of outcome：

Before the intervention,3, 7, 42 days after delivery

Measure method：

scale

指标中文名：

母乳喂养率

指标类型：

主要指标

Outcome：

Breastfeeding rate

Type：

Primary indicator

测量时间点：

产后7天，产后42天，产后6个月

测量方法：

问卷法

Measure time point of outcome：

7 days postpartum, 42 days postpartum, 6 mouths postpartum

Measure method：

questionnaire

指标中文名：

新生儿生长发育

指标类型：

次要指标

Outcome：

Neonatal growth and development

Type：

Secondary indicator

测量时间点：

出生时，产后42天

测量方法：

量表法

Measure time point of outcome：

time of birth,42 days postpartum

Measure method：

scale

指标中文名：

母乳喂养自我效能感

指标类型：

次要指标

Outcome：

Breast-feeding Self-Efficacy

Type：

Secondary indicator

测量时间点：

干预前，产后，产后7天，产后42天

测量方法：

量表法

Measure time point of outcome：

Before the intervention,3, 7, 42 days after delivery

Measure method：

scale

指标中文名：

母乳喂养技能

指标类型：

次要指标

Outcome：

Breastfeeding skills

Type：

Secondary indicator

测量时间点：

产后，产后7天，产后42天

测量方法：

量表法

Measure time point of outcome：

postpartum 7 days postpartum, 42 days postpartum.

Measure method：

scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

None

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 岁 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）：

研究开始之前用EXCEL随机生成80个3位随机数，按数字从小到大顺序编秩，秩次为奇数的为试验组，秩次为偶数的为对照组。将80个随机数字依次装入不透明信封中密封，信封表面不含任何其他信息，由产前区护士保管。

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

Eighty 3-digit random numbers were randomly generated in EXCEL before the start of the study and ranked in order of the numbers from smallest to largest, those with an odd rank were the test group and those with an even rank were the control group. The 80 random numbers were sealed sequentially in opaque envelopes without any other information on the surface of the envelopes, which were kept by the nurses in the antenatal area.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

不适用

Blinding：

not applicable

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）：

使用临床试验公共管理平台http://www.medresman.org.cn/login.aspx，在试验结束6个月内上传试验数据。

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

http://www.medresman.org.cn/login.aspx Upload the test data within 6 months after the end of the experiment.

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：

所有临床资料收集由研究人员确认和双人检查，及时反馈记录，保证资料的真实性。数据录入前，筛选不合格的量表填写资料，双人录入excel，并进行多次核对，确保录入数据的准确性；数据统计过程中遇到问题及时咨询流行病学及统计学专家。

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

All clinical data collection was confirmed and double-checked by the researchers, and timely feedback was recorded to ensure the authenticity of the data. Before data entry, unqualified scale-filling information was screened, double-entered into excel, and checked several times to ensure the accuracy of the entered data; problems encountered in the process of data statistics were promptly consulted with experts in epidemiology and statistics.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-08-13 10:49:32