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NCT Number: NCT07549204

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

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.

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Key information

Conditions

Fear Pregnancy Stress (Psychology)

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Health Belief Model-Based Solution-Focused Childbirth Preparation Education

Behavioral

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 management methods, strategies to reduce fear of childbirth, stress management, relaxation exercises, and strengthening positive beliefs toward normal birth. Solution-focused interventions will be integrated into the program, including the miracle question, scaling questions, future-oriented reflections (e.g., "What would a healthy pregnancy look like for me?"), daily success statements, the helping hand technique, a letter to the future, and minefield clearing exercises.

Standard Antenatal Education (Pregnancy School)

Behavioral

Routine antenatal education provided by the Ministry of Health to pregnant women.

Primary outcomes

  1. 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.

    Fear of childbirth will be assessed using the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ). Version A will be administered during pregnancy at baseline and immediately after completion of the intervention, and Version B will be administered within 48 hours postpartum. Scores range from 0 to 165 for Version A and 0 to 160 for Version B. Higher scores indicate greater fear of childbirth. For Version A, a score of 85 or higher indicates clinical levels of fear of childbirth.

  2. 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.

    Belief in normal birth will be assessed using the Belief Scale for Vaginal Birth. Scores range from 24 to 120. Higher scores indicate stronger belief in normal birth and more positive attitudes toward vaginal birth. Based on total scores, levels of belief in normal birth are classified as low (24-56), moderate (57-88), and high (89-120).

Secondary outcomes

  1. Pregnancy Stress (Pregnancy Stress Rating Scale - PSRS)

    Time frame: Baseline (28-32 weeks of gestation) and immediately after completion of the 3-week intervention.

    Pregnancy-related stress will be assessed using the Pregnancy Stress Rating Scale. Total scores range from 0 to 144. Higher scores indicate greater pregnancy-related stress.

  2. Mode of Delivery

    Time frame: At delivery

    Mode of delivery will be recorded as vaginal birth or cesarean section after childbirth.

Study contacts

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

Seyhan ALPAY

CONTACT

[email protected]

+905388346698

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study 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

Acronym: Primigravida

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
Apr 24, 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.

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