Effect of Theory-Based Childbirth Preparation Education in Nulliparous Pregnant Women

NCT07692724 | Not Yet Recruiting

• 1 other identifier: 251899
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fear of Childbirth Pregnancy Childbirth Education Birth Preferences

Keywords

Fear of Childbirth; Health Belief Model; Self-Efficacy; Childbirth Education; Nulliparous Pregnant Women; Birth Preference; Mode of Delivery; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Fear of Childbirth

  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 Outcomes (4)

• 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

  Baseline, immediately after the intervention, and 4 weeks after the intervention (36-37 weeks' gestation)

• 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

  At the time of childbirth.

Study Arms (2)

arm1

EXPERIMENTAL

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

arm2

ACTIVE COMPARATOR

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

Interventions

Health Belief Model and Self-Efficacy Theory-Based Childbirth Preparation Education BEHAVIORAL

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.

arm1

Routine Antenatal Care OTHER

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.

arm2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sibel Akgül Kartal: lead

MeSH Terms

Interventions

Health Belief Model

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques; Models, Psychological

Central Study Contacts

sibel akgül kartal

CONTACT

05012405539; sibelakgulkartal@yyu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment and statistical analyses will be performed using coded data. Group allocation will be concealed from the data analyst to minimize assessment bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Model Details: Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a Health Belief Model- and Self-Efficacy Theory-based childbirth preparation education program in addition to routine antenatal care, while the control group will receive routine antenatal care only. The education program consists of four structured sessions. Participants will remain in their assigned groups throughout the study, and outcomes will be assessed at baseline, post-intervention, follow-up during late pregnancy, and postpartum.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share