初产妇产前分娩镇痛教育项目对分娩结局的影响：一项随机对照试验的研究方案
Prenatal labor analgesia education program on outcomes for primiparas: study protocol for a randomized controlled trial.
作者信息
Wu Jiali, Chen Jing, Zhang Weiwen, OuYang Jiangtao, Li Jia, Zheng Xujuan
机构信息
Department of Graduate and Scientific Research, Zhuhai Campus of Zunyi Medical University, Zhuhai, China.
Department of Obstetrics, Shenzhen University General Hospital, Shenzhen, China.
出版信息
BMC Public Health. 2025 Jan 24;25(1):316. doi: 10.1186/s12889-025-21562-5.
BACKGROUND
A significant number of primiparous women lack awareness of labor epidural analgesia, resulting in lower acceptance of labor epidural analgesia. Additional prenatal education may help primiparas understand labor epidural analgesia and increase labor epidural analgesia rates. This randomized controlled trial (RCT) will evaluate the effects of an online and offline prenatal labor epidural analgesia education program for primiparas to improve their labor epidural analgesia rate and to reduce their misunderstanding of labor epidural analgesia and fear of birth.
METHODS
A single-blinded, randomized, controlled, parallel-design trial will be conducted. Based on the Theory of Planned Behavior, online and offline prenatal labor epidural analgesia education program has five modules: (a)elementary knowledge, (b)attitude, (c)subjective norm, (d) perceived behavioral control and (e)behavioral intention. Primiparous women will be recruited in the obstetrics department or midwife clinic of a tertiary hospital in Shenzhen, China. The participants (N = 196) will be randomly allocated to the intervention group (N = 98) that receives routine prenatal education and access to the online and offline prenatal labor epidural analgesia education program and the control group (N = 98) that receives routine prenatal education. Labor epidural analgesia rate will be extracted from the electronic medical record; misunderstanding and intention of labor epidural analgesia and fear of birth will be measured at baseline and immediately after the intervention. The study was ethically approved in November 2023.
DISCUSSION
If the online and offline prenatal labor epidural analgesia education program has positive outcomes, it may offer an effective intervention program to decrease misperceptions of labor epidural analgesia and fear of birth and to improve the labor epidural analgesia rate for Chinese primiparas. As the first RCT study to evaluate the effect of the online and offline prenatal labor epidural analgesia education program with a strict research design and a theoretical framework, this research will provide evidence on prenatal labor analgesia health education for clinical practice in China.
TRIAL REGISTRATION
Registered at the Chinese Clinical Trials.gov on January 11th, 2024.
TRIAL REGISTRATION NUMBER
ChiCTR2400079767.
背景
相当数量的初产妇缺乏对分娩硬膜外镇痛的认识，导致分娩硬膜外镇痛的接受率较低。额外的产前教育可能有助于初产妇了解分娩硬膜外镇痛并提高分娩硬膜外镇痛率。这项随机对照试验（RCT）将评估一项针对初产妇的线上和线下产前分娩硬膜外镇痛教育项目的效果，以提高她们的分娩硬膜外镇痛率，并减少她们对分娩硬膜外镇痛的误解和对分娩的恐惧。
方法
将进行一项单盲、随机、对照、平行设计试验。基于计划行为理论，线上和线下产前分娩硬膜外镇痛教育项目有五个模块：（a）基础知识，（b）态度，（c）主观规范，（d）感知行为控制和（e）行为意向。将在中国深圳一家三级医院的产科或助产士诊所招募初产妇。参与者（N = 196）将被随机分配到干预组（N = 98），该组接受常规产前教育并可使用线上和线下产前分娩硬膜外镇痛教育项目，以及对照组（N = 98），该组接受常规产前教育。分娩硬膜外镇痛率将从电子病历中提取；分娩硬膜外镇痛的误解和意向以及对分娩的恐惧将在基线时和干预后立即进行测量。该研究于2023年11月获得伦理批准。
讨论
如果线上和线下产前分娩硬膜外镇痛教育项目有积极结果，它可能提供一个有效的干预项目，以减少中国初产妇对分娩硬膜外镇痛的误解和对分娩的恐惧，并提高分娩硬膜外镇痛率。作为第一项采用严格研究设计和理论框架评估线上和线下产前分娩硬膜外镇痛教育项目效果的RCT研究，本研究将为中国临床实践中的产前分娩镇痛健康教育提供证据。
试验注册
于2024年1月11日在中国临床试验注册中心注册。
试验注册号
ChiCTR2400079767。
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