Effect of Theory-Based Childbirth Preparation Education in Nulliparous Pregnant Women (HBM-SE Birth)

July 3, 2026 updated by: Sibel Akgül Kartal

Effect of a Health Belief Model-and Self-Efficacy Theory-Based Childbirth Preparation Education on Fear of Childbirth, Childbirth Self-Efficacy, and Preferred Mode of Delivery in Nulliparous Pregnant Women: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of a Health Belief Model- and Self-Efficacy Theory-based childbirth preparation education on fear of childbirth, childbirth self-efficacy, birth preferences, and childbirth preparation behaviors among nulliparous pregnant women.

Eligible nulliparous pregnant women between 28 and 32 weeks of gestation will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured childbirth preparation education program consisting of four sessions in addition to routine antenatal care, while the control group will receive routine antenatal care only. Data will be collected before the intervention, immediately after the intervention, during follow-up in late pregnancy, and after childbirth. The findings of this study may contribute to improving childbirth-related outcomes by reducing fear of childbirth and enhancing self-efficacy and preparedness for birth.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Female Aged 18 years or older Nulliparous pregnancy Between 28 and 32 weeks of gestation Able to communicate in Turkish Willing to participate in the study and provide informed consent

Exclusion Criteria:

High-risk pregnancy Diagnosis or treatment of a psychiatric disorder Any condition that may interfere with communication or participation in the educational sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arm1
Participants in this group will receive a structured childbirth preparation education program based on the Health Belief Model and Self-Efficacy Theory in addition to routine antenatal care. The program consists of four educational sessions focusing on fear of childbirth, benefits of vaginal birth, coping skills during labor, and childbirth preparation planning.
Behavioral: Health Belief Model and Self-Efficacy Theory-Based Childbirth Preparation Education
A four-session structured educational program designed to reduce fear of childbirth and improve childbirth self-efficacy, birth preferences, and childbirth preparation behaviors among nulliparous pregnant women.
Active Comparator: arm2
Participants in this group will receive routine antenatal care and standard pregnancy education services provided by the health institution without the structured study intervention.
Other: Routine Antenatal Care
Participants will receive routine antenatal care and standard pregnancy education services provided by the health institution. No structured childbirth preparation education based on the Health Belief Model or Self-Efficacy Theory will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of Childbirth
Time Frame: Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
Fear of childbirth will be assessed using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A). Higher scores indicate higher levels of fear of childbirth.
Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childbirth Self-Efficacy
Time Frame: Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
Childbirth self-efficacy will be assessed using the Childbirth Self-Efficacy Inventory Short Form (CBSEI-C32). Higher scores indicate higher levels of childbirth self-efficacy.
Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
Birth Preference
Time Frame: Baseline, immediately after the intervention, and 4 weeks after the intervention (36-37 weeks' gestation)
Birth preference will be assessed using the Pregnant Women's Preferences for Mode of Delivery Questionnaire. Higher scores indicate a stronger preference for vaginal birth.
Baseline, immediately after the intervention, and 4 weeks after the intervention (36-37 weeks' gestation)
Childbirth Preparation Behaviors
Time Frame: Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
Childbirth preparation behaviors will be assessed using the Childbirth Preparation Behavior Form developed by the researchers. The questionnaire evaluates the extent to which pregnant women engage in behaviors to prepare for childbirth. Higher scores indicate better childbirth preparation behaviors.
Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
Actual Mode of Delivery
Time Frame: At the time of childbirth.
Actual mode of delivery will be recorded using the Birth Record Form and categorized as vaginal birth or cesarean birth.
At the time of childbirth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sibel Akgül Kartal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

July 3, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251899

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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