A single-blinded, randomized, controlled, parallel design will be conducted to assess the effect of PAP on Chinese primiparous women in the third trimester. The study follows the SPIRIT 2013 Statement and the Standard Protocol of Clinical Trials guidelines [28]. The schematic diagram of recruitment, intervention, and evaluation is shown in Fig. 1.

The schematic diagram of recruitment, intervention, and evaluation. Abbreviations: W-DEQ-A-SC: Simplified Chinese version of the Wijma Delivery Expectancy Questionnaire; TPBT: Self-rating scale of painless delivery intention based on the theory of planned behavior; LEA: Labor epidural analgesia; PAP: Online and Offline Prenatal Epidural Labor Analgesia Education Program
Study setting and participants
The research will be carried out in a tertiary hospital in China. The inclusion criteria will be: (1) single pregnancy primipara confirmed by ultrasound; (2) aged 18 years or above; (3) no complications of pregnancy or other organic diseases, e.g., heart disease, chronic kidney disease, serious cardio-cerebrovascular, digestive, or hepatic function disorders. (4) have the ability to understand and be proficient in Mandarin and Chinese characters. (5) ability to use a WeChat public account and WeChat group. (6) willing to participate in this study. The exclusion criteria will be (1) with contraindications to epidural anesthesia (e.g., coagulopathy); (2) with severe mental or physical diseases (e.g., major depressive disorder or severe hypertension); (3) attending other painless childbirth education programs at the same time; Dropout criteria: (1) participants withdrew from the study due to various reasons; (2) through medical diagnosis must be cesarean section; (3) delivered before 37 weeks of gestation. In addition, the inclusion criteria for spouses were the same as those for primiparas in Criteria 2, 3, 4, 5, and 6, and their exclusion criteria were identical to Criteria 2 and 3 for primiparas.
Recruitment
Participants will be recruited when pregnant women attend a tertiary hospital’s obstetrics clinic or midwife clinic. Since recruitment is one-on-one at the clinic, this greatly avoids intergroup contamination. The obstetric nurses will orally introduce the purpose and content of this study to women who meet the inclusion criteria. The researchers will approach women who verbally agree to participate by providing them with written informed consent and answering any questions about the research. In this approach, primiparas will not be asked to make on-the-spot decisions to ensure they have enough time to read the informed consent and discuss it with their family members. The researchers will acquire participants’ written informed consent when they initiate contact. Data will be collected before randomization (baseline) and immediately after the intervention. Recruitment of participants began in January 2024.
Sample size
The sample size will be calculated based on previous research [15].The study found that the LEA rate was 80% in the intervention group and 60% in the control group. We use the following formula:
$$\:N=\frac\left[Z_\alpha\:\sqrt2P\left(1-P\right)+Z_\beta\:\sqrtP_c\left(1-P_c\right)+P_e(1-P_e)\right]^2\left(P_c-P_e\right)^2$$
(α = 0.05, β = 0.20; Zα=1.96, Zβ=0.84; Pc = 0.80, Pe = 0.60, P=(Pc + Pe)/2)
Each group will be 81 primiparous women. Assuming an attrition rate of about 20%, 196 women (98 in each group) are required.
Randomization and blinding
A computerized random number generator will be used to randomly assign participants into the intervention group and the control group with a distribution ratio of 1:1. The allocation sequence will be put into opaque and sealed envelopes by investigators not directly associated with this project to ensure that the randomization assignment is not leaked in advance. Blinding will not be possible for the researchers during the research process; however, the group allocation will be masked to participants and outcome assessors. Additionally, to avoid implementation bias during childbirth, anesthesiologists, labor nurses, and obstetricians will be blinded to group assignments. Unblinding will occur after the intervention is complete.
Intervention
Primiparas assigned to the control group will receive routine education at the hospital’s antenatal clinic. Routine education includes (1) access to labor pain pamphlets (2) posters and bulletin boards for the obstetrics department outpatient clinic. Primiparas assigned to the intervention group will receive PAP in addition to the above routine health education. When the researcher distributes brochures to primiparous women in the control group, they will briefly explain the main content (approximately 3–5 min). Pregnant women will then be guided to view the bulletin boards at their discretion.
The theoretical framework of PAP was based on the Theory of Planned Behavior (TPB), which was developed by American psychologist Ajzen [29]. The theory describes how behavioral intentions influence people’s actual behavior. It consists of five elements: attitude, subjective norm, perceived behavioral control, and behavioral intentions and behaviors [30]. The theory is well-developed and can guide intervention models, predict individual behavioral attitudes and changes, and intervene promptly to improve personal attitudes toward things and thus promote the implementation of behavior. It has been successfully applied to intervention studies of other diseases [31, 32]. In this study, behavioral attitudes refer to the positive or negative evaluations of women’s attitudes toward painless delivery; subjective norms refer to the pressure women feel from their family and friends, especially their spouses, to support or oppose their decision to give birth; perceived behavioral control refers to the level of obstacles women perceive they will face if they choose to give birth without pain and the level of self-confidence in their behaviors; and behavioral intention refers to the final decision of women for epidural labor analgesia. LEA-related knowledge may affect women’s awareness of LEA as an available choice in the future [33]. Therefore, PAP used the extended TPB theory (ETPB) [34] to guide the implementation of the intervention. The theoretical framework of the PAP is shown in Fig. 2.

The theoretical framework of the PAP. Note: The theoretical framework of the PAP was adapted from XueCheng [34]
Video presentations are one of the most commonly used forms of health education in labor analgesia. Video is more vivid and specific than verbal explanations or pictures, freeing health professionals from time-consuming, repetitive explanations [19, 35]. We will also incorporate other formats, such as pictures, text, etc. According to the situation in China, we use WeChat, a popular social software, as an online education platform, combining face-to-face classes and one-on-one interviews for intervention. The first phase of PAP reflects basic knowledge and attitudes and begins at 29–32 weeks of gestations. The details of the intervention are described in Table 1.
PAP (Fig. 3) lasts approximately eight weeks and is divided into 3 phases. Phase 1 is learning about knowledge and misconceptions of LEA, as shown by WeChat. The contents include (1) Definition, procedure, contraindications and indications, advantages, and side effects of LEA; (2) Common misconceptions about LEA, such as postpartum back pain, nerve damage, breastfeeding, and baby’s intelligence (these misconceptions were summarized from three sources: collected from the online, previously published literature and in-person interviews); (3) Advantages and processes of natural childbirth; mechanisms and adverse effects of labor pain, and various methods of pain relief. Pregnant women can read/watch the texts/videos freely and repeatedly and can discuss medical decisions with their family members. To increase compliance with this phase of the intervention, we will take the following measures: First, participants will receive weekly reminders during the first phase via phone or WeChat (a total of four reminders). Second, through the management interface of the WeChat Official Account Mini Program, researchers can monitor the number of visitors. If the number of visits within a given week is insufficient, additional reminders will be sent as needed.
The second phase of PAP reflects subjective norms and perceptual behavioral control and begins at 33–34 weeks of pregnancy. The theme of the second phase is to feel supported by others and overcome difficulties. The contents include (1) We will invite the partner to experience labor pains and then encourage him to express his feelings. The aim is to enhance the women’s perception of the support of significant others; (2) Invite women who have experienced LEA to share their feelings. (Inclusion criteria were: natural delivery of a baby; successful use of LEA and having a favorable impression of it); (3) Use PowerPoint and video to explain the preparation process and precautions of LEA, including the appointment process, the preparation of materials, coordination of body position, relaxation training. The purpose is to increase the proficiency of maternal cooperation, improve maternal tension and fear, and enhance courage and confidence. At this stage, we will carry out offline courses in batches according to when the pregnant women come to the hospital for prenatal examination. It is expected that there will be about 5–10 pregnant women in each batch.
The behavioral intention is reflected in the third phase of PAP. We will conduct one-to-one counseling at 35–36 weeks of pregnancy for both pregnant women and spouses. We will give counseling tailored according to their education level and cultural background, summarise and solve confusions and unresolved individualized difficulties encountered by the pregnant woman and her partner in the above interventions, and encourage them to express their thoughts and feelings at this stage.

Intervention model of PAP
Outcome measurement
Primary outcome
LEA rate: epidural usage will be extracted from the electronic medical record.
Secondary outcomes
The intention of LEA: it will be measured using the self-rating scale of Painless Delivery Intention based on the Theory of Planned Behavior (TPBT), developed for Chinese women to objectively judge the maternal behavioral intention of painless labor. The scale is a five-Likert self-rating instrument consisting of 30 items with a total score of 30–150. Greater scores correspond to a higher intention for painless childbirth among parturients. The scale’s overall Cronbach’s alpha coefficient was 0.971, the scale-level content validity index (S-CVI) was 0.984, and the item-level content validity index (I-CVI) was between 0.909-1.000 [34].
Fear of birth: Women’s fear of birth will be assessed with the Simplified Chinese version of the Wijma Delivery Expectancy Questionnaire (W-DEQ-A-SC). This scale was initially developed by Swedish academic Klaas Wijma in 1998 and later underwent a process of cultural adaptation and validation by Chinese researchers in 2015 [36]. The scale consists of 33 self-report items across six dimensions: Positive Emotions (items 1, 13, 14, 18), Fear and Reactions (items 2, 6, 12, 17, 19, 24, 25, 27), Feelings of Helplessness (items 3, 7, 11, 15, 20), Risk Perception (items 31, 32, 33), Childbirth Cognition (items 9, 28, 29, 30, 21), and Self-Efficacy (items 4, 5, 8, 10, 16, 22, 23, 26). The scale total score ranges from 0 to 165 and applies to pregnant women during the gestational period of 28 to 41 weeks. The higher score equates to a greater fear of childbirth. The Cronbach’s alpha coefficient of the scale in the Chinese version was 0.928, the content validity was 0.94, the test-retest reliability was 0.968, and the split-half reliability was 0.934 [36].
Misconceptions about LEA: The misperceptions of LEA will be evaluated with a 12-item questionnaire developed by Brandon M. Togioka [15]. The questionnaire includes 12 false statements about epidural analgesia. Primiparous women and spouses will be asked whether they agreed or disagreed with the statements. In this study, the researcher and another person proficient in English translated the questionnaire. If there were any disagreements, a third person would be consulted.
Data collection procedure
The baseline assessment will be conducted by the researchers, and each participant will be asked to complete the TPBT, W-DEQ-A-SC, epidural questionnaire, and social-demographic and clinical data in the obstetric clinic. A post-test will be conducted immediately after the intervention. Regardless of the reasons for withdrawal, we will make every effort to invite participants to complete the questionnaire to ensure data integrity. If face-to-face completion is impossible, all scales will be sent to participants via WeChat or email, and completed questionnaires will be returned to investigators via WeChat or email. The rate of LEA will be extracted from the electronic medical record during the postpartum period.
Data analysis
Data will be entered independently by two researchers and analyzed using the Statistical Package for Social Sciences 29.0 (SPSS 29.0). Intention-to-treat analysis (ITT) will be used to deal with missing data. The socio-demographic and clinical characteristics of primiparas will be presented as means ± standard deviations (SDs) for continuous characteristics and frequencies and proportions for categorical characteristics. Two study groups will be compared regarding baseline characteristics using Chi-square (χ2) tests and the independent sample t-test. If significant differences are found, these potential confounding factors will be adjusted for in the outcomes analysis. The primary outcomes (LEA rate) will be compared using Chi-square (χ2) tests. Welch’s t-tests will detect the secondary endpoint (Intention of LEA, Fear of Birth, and Misconceptions about LEA). We chose Welch’s t-test to make our statistical inference more robust and avoid possible violations of standard model assumptions. P value of less than 0.05 will be considered statistically significant for all analyses.
Ethical considerations
Research ethical committee approval is obtained by the Research Ethics Committee of a tertiary hospital in Shenzhen(approval number KYLL-20231102 A). The registration number with the Chinese Clinical Trial Registry is ChiCTR2400079767. Ethical standards will be maintained throughout the whole process. There is no potential risk or harm in taking part in this program. Primiparous women will not be deprived of any treatment and routine care. Written informed consent will be obtained before data collection. Participants will be reassured that they have the right to withdraw from the study at any time without adversely affecting their pregnancy management. All of the collected data will be kept anonymously and confidentially.
Validity and reliability
This study uses a rigorous experimental design. This includes a scientific theoretical framework, high reliability and validity tools, and statistical scientific analysis. The composition of members of the study team reflects the collaboration of a multidisciplinary staff: obstetric and anesthesiology professionals provide knowledge and ensure accurate information on the conduct of this study. Professional statisticians, doctors of nursing science, and postgraduates can effectively ensure the quality control of the research process and the accuracy of data analysis, and clinical nurses are responsible for the organization and coordination of the department. To ensure the homogeneity of the intervention, we will provide standardized training to relevant members before the intervention and data collection to minimize bias.
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