ChiCTR2600117654 版本V1.0 版本创建时间2026/01/27 15:45:23 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：

 ChiCTR2600117654 

最近更新日期：

Date of Last Refreshed on：

 2026-01-27 15:45:18 

注册时间：

Date of Registration：

 2026-01-27 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

初产妇分娩恐惧接纳承诺干预方案的构建及其应用研究

Public title：

Construction and Application Research of an Acceptance and Commitment Therapy (ACT)-Based Intervention Program for Primiparas' Fear of Childbirth

注册题目简写：

English Acronym：

研究课题的正式科学名称：

初产妇分娩恐惧接纳承诺干预方案的构建及其应用研究

Scientific title：

Construction and Application Research of an Acceptance and Commitment Therapy (ACT)-Based Intervention Program for Primiparas' Fear of Childbirth

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：

黄可寒 

研究负责人：

邱萍萍 

Applicant：

Kehan Huang 

Study leader：

Pingping Qiu 

申请注册联系人电话：

Applicant telephone：

 +86 591 2286 5620

研究负责人电话：

Study leader's
telephone：

+86 591 2286 5620

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：

 1350298015@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 qiupingping@139.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：

福建省福州市闽侯县大学城学府北路1号

研究负责人通讯地址：

福建省福州市闽侯县大学城学府北路1号

Applicant address：

No. 1, Xuefu North Road, University Town, Minhou County, Fuzhou City, Fujian Province

Study leader's address：

No. 1, Xuefu North Road, University Town, Minhou County, Fuzhou City, Fujian Province

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：

福建医科大学护理学院

Applicant's institution：

School of Nursing, Fujian Medical University

研究负责人所在单位：

福建医科大学护理学院

Affiliation of the Leader：

School of Nursing, Fujian 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：

 福医伦理审字[2025]第300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：

福建医科大学生物医学研究伦理审查委员会

Name of the ethic committee：

Ethics Committee of Fujian Maternity and Child Health Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-09 00:00:00

伦理委员会联系人：

张俊

Contact Name of the ethic committee：

Jun Zhang

伦理委员会联系地址：

福建省福州市闽侯县大学城学府北路1号

Contact Address of the ethic committee：

No. 1, Xuefu North Road, University Town, Minhou County, Fuzhou City, Fujian Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 591 8762 0092

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：

福建医科大学护理学院

Primary sponsor：

School of Nursing, Fujian Medical University

研究实施负责（组长）单位地址：

福建省福州市闽侯县大学城学府北路1号

Primary sponsor's address：

No. 1, Xuefu North Road, University Town, Minhou County, Fuzhou City, Fujian Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建

市(区县)：

福州

Country：

China

Province：

Fujian

City：

Fuzhou

单位(医院)：

福建省妇幼保健院

具体地址：

福建省福州市道山路18号

Institution
hospital：

Fujian Provincial Maternity and Children's Hospital

Address：

No.18 Daoshan Road, Fuzhou, Fujian P.R.China

经费或物资来源：

自筹

Source(s) of funding：

Self-funding

研究疾病：

分娩恐惧  

Target disease：

Fear of Childbirth

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

验证初产妇分娩恐惧接纳承诺干预方案对初产妇分娩恐惧、心理灵活性等的干预效果。  

Objectives of Study：

To verify the intervention effects of the Acceptance and Commitment Intervention (ACT) program on fear of childbirth, psychological flexibility, and other related outcomes among primiparas.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.初产妇，年龄>=20岁（女性法定结婚年龄）； 2.单胎妊娠，28周<=怀孕<=33周； 3.FOBS>=65分； 4.语言表达能力正常，能独立接受本次研究； 5.在与本研究团队有合作关系的两个卫生服务中心之一建档。

Inclusion criteria

1. Primiparous women, aged >= 20 years (the legal marriage age for women); 2. Singleton pregnancy, 28 weeks <= pregnancy <= 33 weeks; 3. FOBS >= 65 points; 4. Normal language expression ability, able to independently participate in this study; 5. Registered at one of the two health service centers that have a cooperative relationship with our research team.

排除标准：

1.已接受或正在接受其他非常规心理治疗或干预； 2.有剖腹产指征； 3.通过辅助生殖技术获得妊娠； 4.胎儿生长发育异常； 5.既往或现患精神类疾病； 6.GAD-7>=10分； 7.PHQ-9>=10分。

Exclusion criteria：

1. Has received or is currently receiving other unconventional psychological treatments or interventions; 2. Has indications for cesarean section; 3. Has achieved pregnancy through assisted reproductive technology; 4. There are abnormal fetal growth and development; 5. Has had or currently has mental disorders; 6. GAD-7 score >= 10 points; 7. PHQ-9 score >= 10 points.

研究实施时间：

Study execute time：

从 From 2025-07-15 00:00:00至 To 2027-07-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-16 00:00:00 至 To 2027-07-15 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 33

Group：

Control Group

Sample size：

干预措施：

接受常规产前保健，具体内容包括：（1）督促配偶陪同初产妇定期进行常规产前检查，即基础检查（生命体征的测量、体重的测量、血糖的测量、血常规、尿常规的检查等）和专科检查（测量宫高和腹围、胎心监测、胎位、宫颈检查、NST等）。（2）从入组后开始，每隔一周，鼓励初产妇参加孕妇学校的线下健康教育课程，并通过微信分享孕妇学校的线上健康教育课程课程，第一周分娩内容包括：促进自然分娩、关于无痛分娩、孕期营养与体重管理。第二周分享内容包括：自数胎动、孕期运动、母乳喂养。第三周分享内容包括：科学坐月子、产后康复、新生儿保健。在第一周、第二周分享课程后，通过微信测评结局指标，第三周则是预约其产检时间，在医院线下见面测评结局指标。（3）及时回复初产妇所提出的问题，给予初产妇所需要的帮助，解决其对分娩存在的问题。

干预措施代码：

Intervention：

Receive routine prenatal care, which includes the following specific contents: (1) Urge the partner to accompany the primiparous women to undergo regular prenatal examinations on a regular basis, including basic examinations (measurement of vital signs, weight measurement, blood sugar measurement, blood routine tests, urine routine tests, etc.) and specialized examinations (measurement of uterine height and abdominal circumference, fetal heart rate monitoring, fetal position, cervical examination, NST, etc.). (2) Starting from the time of enrollment, every week, encourage the primiparous women to attend offline health education courses at the maternity school and share the online health education courses of the maternity school via WeChat. The content of the first week of delivery includes: promoting natural childbirth, information on painless childbirth, pregnancy nutrition and weight management. The content of the second week includes: self-counting of fetal movements, pregnancy exercises, breastfeeding. The content of the third week includes: scientific postpartum recuperation, postpartum rehabilitation, and neonatal care. After sharing the courses in the first and second weeks, evaluate the outcome indicators through WeChat, and in the third week, make an appointment for the primiparous women to visit the hospital for an in-person assessment of the outcome indicators. (3) Reply promptly to the questions raised by the primiparous women, provide the help they need, and solve their problems regarding childbirth.

Intervention code：

组别：

干预组

样本量：

 33

Group：

Intervention Group

Sample size：

干预措施：

干预组：由实施可行性研究的两名干预者在常规产前保健的基础上，进行初产妇分娩恐惧接纳承诺干预方案干预。干预内容主要围绕接纳承诺疗法的核心理念展开，包括接纳分娩恐惧、认知解离、接触当下、以己为景、澄清价值以及承诺行动六大模块。干预周期为4周；频率为每周1次（共4次）；每次为60分钟左右。第1次与第2次干预采取线上一对一干预，第3次与第4次干预采取线下3~5人小组干预。第1次干预主题为享受妊娠、容“惧”其中，包接触当下和接纳两个模块，通过线上一对一进行干预，指导产妇进行正念呼吸训练等，帮助初产妇把注意力集中在此时此刻，享受妊娠的美好时光，减少沉浸于过去的负面分娩记忆和对未来的分娩的担忧。同时，对分娩恐惧这一情绪保持开放态度，允许它的存在，为它腾出空间，放弃与之回避、对抗。第2次干预主题为与“惧”解离、卸下“标签”，包括认知解离和以己为景两个模块，通过线上一对一进行干预，指导初产妇进行“把情绪和想法写在卡片上”等练习，旨在帮助初产妇与分娩恐惧情绪及相关想法解离和从观察者的角度看待自己的恐惧情绪及相关想法。第3次干预主题为心之所向、价值引航，包含澄清价值模块，通过线下3~5人小组干预，指导初产妇思考自我价值并进行排序等，帮助初产妇明确自己与分娩相关的价值，作为后续目标设定和行动计划的指引。第4次干预主题为学以致用、为所当为，包含承诺行动模块，通过线下3~5人小组干预，指导产妇设置目标、列行动计划等，帮助初产妇在其价值的引导与驱动下制定行动计划，为采取有效行动奠定基础。通过一系列的心理护理和体验式练习，帮助初产妇学会接纳自己的分娩恐惧情绪，区分恐惧想法与事实，培养自我觉察能力，保持正念，接触当下，明确个人价值，并基于这些价值设定分娩准备目标和行动计划。

干预措施代码：

Intervention：

Intervention group: Two interventionists who conducted the feasibility study carried out the initial parturient fear acceptance commitment intervention program based on routine prenatal care. The intervention content mainly focused on the core concepts of acceptance commitment therapy, including accepting fear of childbirth, cognitive dissociation, being in the present moment, viewing oneself as the scenery, clarifying values, and committing to actions. The intervention period was 4 weeks; the frequency was once a week (for a total of 4 times); each session lasted about 60 minutes. The first and second interventions were conducted through online one-on-one intervention, while the third and fourth interventions were conducted through offline 3-5 person group intervention. The first intervention theme was "Enjoy Pregnancy and Face 'Fear' Within", covering two modules: being in the present moment and accepting. The intervention was conducted online one-on-one, guiding the parturient to perform mindfulness breathing training and other exercises, helping the parturient focus on the present moment, enjoy the beauty of pregnancy, and reduce the negative childbirth memories from the past and concerns about future childbirth. At the same time, an open attitude towards the fear emotion was maintained, allowing its existence, creating space for it, and giving up avoidance and confrontation with it. The second intervention theme was "Disassociate from 'Fear' and Let Go of 'Labels'", including two modules: cognitive dissociation and viewing oneself as the scenery. The intervention was conducted online one-on-one, guiding the parturient to practice "writing emotions and thoughts on cards", aiming to help the parturient dissociate from the fear emotion and related thoughts and view their fear emotions and related thoughts from an observer's perspective. The third intervention theme was "Where the Heart Leads and Value Guides", including the clarification of values module. The intervention was conducted through offline 3-5 person group intervention, guiding the parturient to think about self-worth and sort it out, aiming to help the parturient clarify their values related to childbirth and use them as a guide for subsequent goal setting and action plans. The fourth intervention theme was "Learn and Put into Practice, Do What Should Be Done", including the commitment action module. The intervention was conducted through offline 3-5 person group intervention, guiding the parturient to set goals and create action plans, helping the parturient formulate action plans under the guidance of their values, laying the foundation for taking effective actions. Through a series of psychological care and experiential exercises, the parturient learned to accept their fear of childbirth emotions, distinguish between fear thoughts and facts, cultivate self-awareness ability, contact the present moment, clarify personal values, and set goals and action plans for childbirth preparation based on these values.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

 福州 

Country：

China

Province：

Fujian

City：

Fuzhou

单位(医院)：

 福建省妇幼保健院 

单位级别：

 三甲 

Institution
hospital：

Fujian Provincial Maternity and Children's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

分娩恐惧

指标类型：

主要指标

Outcome：

Fear of Childbirth

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心理灵活性

指标类型：

主要指标

Outcome：

Psychological flexibility

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

分娩信念

指标类型：

次要指标

Outcome：

Birth Beliefs

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

分娩应对方式

指标类型：

次要指标

Outcome：

Birth Coping Style

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

分娩倾向

指标类型：

次要指标

Outcome：

Childbirth preference

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

对阴道分娩的信心和了解程度

指标类型：

次要指标

Outcome：

Confidence in and Knowledge About Vaginal Delivery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

分娩体验

指标类型：

次要指标

Outcome：

Childbirth Experience

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：

主要指标

Outcome：

Heart rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心率变异性

指标类型：

主要指标

Outcome：

Heart Rate Variability

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

皮肤导电性

指标类型：

主要指标

Outcome：

Skin Conductance

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

皮肤温度

指标类型：

主要指标

Outcome：

Skin Temperature

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：

无

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：

正在进行

Recruiting

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）：

由第三方人员采用随机数字表法随机

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

By third-party personnel using the random number table method randomly

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

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

是Yes

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）：

研究结束后，通过ResMan(www.medresman.org.cn)方式共享

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

After the end of the study, it was shared by ResMan (www.medresman.org.cn).

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：

CRF;EDC

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

CRF;EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-01-27 15:45:18