Prenatal labor analgesia education program on outcomes for primiparas: study protocol for a randomized controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 100968562 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2458 (Electronic) Linking ISSN: 14712458 NLM ISO Abbreviation: BMC Public Health Subsets: MEDLINE

Original Publication: London : BioMed Central, [2001-

Analgesia, Epidural*/statistics & numerical data ; Analgesia, Obstetrical* ; Prenatal Education*/methods ; Labor, Obstetric* ; Prenatal Care*/methods; Humans ; Female ; Pregnancy ; China ; Single-Blind Method ; Adult ; Randomized Controlled Trials as Topic ; Parity

Competing Interests: Declarations. Ethics approval and consent to participate: The study was approved by the Ethics Committee for Scientific Research of Shenzhen University General Hospital (Approval Number: KYLL-20231102 A). Consent for publication: Not applicable. Competing interests: The authors declare no competing interests. Roles and responsibilities: During the clinical implementation, the Scientific Research Ethics Committee of Shenzhen University General Hospital will supervise this study. Individuals who have obtained China GCP (Good Clinical Practice) certification will manage the study. Given that this study will not involve biological samples and will present minimal risk, a specialized Data Monitoring Committee (DMC) will not be established; instead, data management will be overseen solely by designated individuals.
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.
(© 2025. The Author(s).)

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20200804101756002 the General Program of Stable Support Plan for Universities in Shenzhen City

Keywords: Health education; Labor epidural analgesia; Prenatal education program; Primiparas; Study protocol

ChiCTR ChiCTR2400079767

Date Created: 20250125 Date Completed: 20250125 Latest Revision: 20250503

20250503

PMC11762463

10.1186/s12889-025-21562-5

39856700