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HBM-Based Solution-Focused Birth Program for Fear of Childbirth in Primigravidas

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Summary

This ClinicalTrials.gov record (NCT07549204) registers a randomized controlled trial evaluating a Health Belief Model-based solution-focused childbirth preparation education program against standard antenatal care, targeting fear of childbirth (tokophobia) in first-time pregnant women. The four-year trial will enroll participants in intervention and control groups, measuring fear levels, belief in normal birth, pregnancy-related stress, and delivery mode as outcomes. Findings are intended to inform maternal psychological well-being interventions and positive childbirth experience strategies.

“Participants will be randomly assigned to either an intervention group receiving structured education or a control group receiving routine prenatal care.”

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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

This ClinicalTrials.gov record registers NCT07549204, a randomized controlled trial assessing a Health Belief Model-based solution-focused childbirth preparation education program against standard antenatal pregnancy school education. The trial targets fear of childbirth (tokophobia) in primigravida women as the primary condition, with secondary outcomes including pregnancy-related stress and mode of delivery. Participants will be randomly assigned to the structured intervention or control group receiving routine prenatal care, with data collected before and after the intervention using validated measurement tools.

Healthcare providers and clinical researchers studying maternal mental health may find the trial outcomes relevant to informing prenatal education program design. The study's focus on psychological well-being and cesarean section rates aligns with broader maternal health quality-improvement objectives. Institutions offering antenatal education should monitor trial findings for potential incorporation into standard prenatal care programming.

Archived snapshot

Apr 24, 2026

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← ClinicalTrials.gov Studies

HBM-Based Solution-Focused Birth Program on Fear of Childbirth in Primigravidas

N/A NCT07549204 Kind: NA Apr 24, 2026

Abstract

Pregnancy is a period characterized by significant physiological and psychosocial changes, during which women adapt to new roles. While some women experience this period with excitement and hope, others may experience anxiety, uncertainty, and fear. Fear of childbirth (tokophobia) is a common condition that can negatively affect women's quality of life, birth preferences, and childbirth experiences. High levels of fear of childbirth have been associated with increased cesarean section rates, negative birth perceptions, and postpartum psychological problems.

This randomized controlled trial aims to evaluate the effect of a solution-focused childbirth preparation education program based on the Health Belief Model on fear of childbirth and belief in normal birth among primigravida women. Secondary outcomes include pregnancy-related stress and mode of delivery.

Participants will be randomly assigned to either an intervention group receiving structured education or a control group receiving routine prenatal care. Data will be collected before and after the intervention using validated measurement tools, and delivery outcomes will be recorded after birth. The findings are expected to contribute to improving maternal psychological well-being and promoting positive childbirth experiences.

Conditions: Fear, Stress (Psychology), Pregnancy

Interventions: Health Belief Model-Based Solution-Focused Childbirth Preparation Education, Standard Antenatal Education (Pregnancy School)

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Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial design Maternal health research Prenatal education
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Public Health Pharmaceuticals

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