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

Official title

The Effect of a Health Belief Model-Based Solution-Focused Childbirth Preparation Program on Fear of Childbirth, Belief in Normal Birth, Pregnancy Stress, and Mode of Delivery in Primigravid Women

Overview

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.

Detailed description

Pregnancy is a unique period characterized by significant physiological and psychosocial changes, during which women adopt new roles and adapt to this transition. Fear of childbirth (tokophobia) is a common condition that can negatively affect women's quality of life, childbirth preferences, and delivery outcomes. High levels of fear of childbirth have been associated with increased cesarean section rates and adverse psychological outcomes.

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

Eligible participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured childbirth preparation education program based on the Health Belief Model and a solution-focused approach, while the control group will receive the standard antenatal education program provided by the Ministry of Health (Pregnancy School).

Data will be collected at three time points: before the intervention, after the intervention, and in the postpartum period, using validated measurement tools. Delivery outcomes will be recorded following birth.

Interventions

• Behavioral Health Belief Model-Based Solution-Focused Childbirth Preparation Education
  A structured face-to-face childbirth preparation education program based on the Health Belief Model and solution-focused approach will be delivered to pregnant women between 28 and 32 weeks of gestation in small groups of 5-10 participants. The intervention consists of six sessions conducted twice weekly over three weeks by a researcher certified in solution-focused approach practitioner training. Content includes pregnancy education, stages of labor, modes of birth, non-pharmacological pain man
• Behavioral Standard Antenatal Education (Pregnancy School)
  Routine antenatal education provided by the Ministry of Health to pregnant women.

Primary outcome measures

• Fear of Childbirth (Wijma Delivery Expectancy/Experience Questionnaire - W-DEQ Version A and B) [Time frame: Version A: Baseline (28-32 weeks of gestation) and immediately after completion of the 3-week intervention; Version B: within 48 hours postpartum.]
• Belief in Normal Birth (Belief Scale for Vaginal Birth - BSVB) [Time frame: Baseline (28-32 weeks of gestation) and immediately after completion of the 3-week intervention.]

Secondary outcome measures (2)

• Pregnancy Stress (Pregnancy Stress Rating Scale - PSRS) [Time frame: Baseline (28-32 weeks of gestation) and immediately after completion of the 3-week intervention.]
• Mode of Delivery [Time frame: At delivery]

Eligibility criteria

Inclusion criteria

• Being 18 years of age or older
• Having at least a primary school level of education
• Being able to understand and speak Turkish
• Having a singleton pregnancy
• Being a primigravida
• Being between 28 and 32 weeks of gestation at the time of the intervention.

Exclusion criteria

• Having a high-risk pregnancy (e.g., preeclampsia, diabetes, cardiovascular disease, placenta previa, oligohydramnios)
• Having a chronic and/or psychiatric disorder
• Having conceived through infertility treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Turkey (Türkiye) · 1 center

• Ordu University — Ordu

Publications

• Abdelaziz EM, Alshammari AM, Elsharkawy NB, Oraby FA, Ramadan OME. Digital intervention for tokophobia: a randomized controlled trial of internet-based cognitive behavioral therapy on fear of childbirth and self-efficacy among Egyptian pregnant women. BMC Pregnancy Childbirth. 2025 Mar 3;25(1):233. doi: 10.1186/s12884-025-07341-5. PMID 40033245

Identifiers

NCT: NCT07549204 · PRIMIHBMRCT2026 · 2025/31 (27 October 2025)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗