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NCT Number: NCT07692724

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

sibel akgül kartal

CONTACT

[email protected]

05012405539

Sponsors and collaborators

Lead sponsor

Sibel Akgül Kartal

Other

Registry information

Official study title

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

Acronym: HBM-SE Birth

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.