Fear of Childbirth Pregnancy Childbirth Education Birth PreferencesHBM-SE BirthNCT07692724
Effect of Theory-Based Childbirth Preparation Education in Nulliparous Pregnant Women
A study testing Health Belief Model and Self-Efficacy Theory-Based Childbirth Preparation Education and Routine Antenatal Care in people with Fear of Childbirth Pregnancy Childbirth Education Birth Preferences, run by Sibel Akgül Kartal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth Pregnancy Childbirth Education Birth Preferences
- What is being tested?
- Health Belief Model and Self-Efficacy Theory-Based Childbirth Preparation Education and Routine Antenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- High-risk pregnancy Diagnosis or treatment of a psychiatric disorder Any condition that may interfere with communication or participation in the educational sessions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Being tested
- Health Belief Model and Self-Efficacy Theory-Based Childbirth Preparation Education, Routine Antenatal Care
- Keywords
- Fear of Childbirth, Health Belief Model, Self-Efficacy, Childbirth Education, Nulliparous Pregnant Women, Birth Preference, Mode of Delivery, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Belief Model and Self-Efficacy Theory-Based Childbirth Preparation EducationBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Antenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
Birth Preference
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.
Measured: Baseline, immediately after the intervention, and 4 weeks after the intervention (36-37 weeks' gestation)
Childbirth Preparation Behaviors
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.
Measured: 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
Actual mode of delivery will be recorded using the Birth Record Form and categorized as vaginal birth or cesarean birth.
Measured: At the time of childbirth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of Childbirth Pregnancy Childbirth Education Birth PreferencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sibel Akgül Kartal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sibel Akgül Kartal, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692724
- Sponsor's protocol ID
- 251899
- Acronym
- HBM-SE Birth
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No