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Not yet recruitingNCT07549204PrimigravidaUpdated Apr 24, 2026

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

An interventional study of Health Belief Model-Based Solution-Focused Childbirth Preparation Education and Standard Antenatal Education (Pregnancy School) in Fear, Stress (Psychology) and Pregnancy, sponsored by Ordu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Ordu University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Fear
  • Stress (Psychology)
  • Pregnancy

Keywords

  • Pregnancy
  • Fear
  • Health Belief Model
  • Solution-Focused Approach
  • Antenatal Education
  • Mode of Delivery
  • Randomized Controlled Trial
03

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Participants will receive a structured childbirth preparation education program consisting of six sessions based on the Health Belief Model and solution-focused approach principles. The program will be delivered face-to-face by the researcher to pregnant women at 28-32 weeks of gestation, twice weekly for three weeks, in small groups of 5-10 participants. The sessions will include education on pregnancy, stages of labor and modes of birth, non-pharmacological methods for coping with labor pain, coping strategies to reduce fear of childbirth, stress management, relaxation exercises, and promotion of positive beliefs toward normal birth. The intervention will be conducted in accordance with the principles of the Health Belief Model and the solution-focused approach.

    Behavioral: Health Belief Model-Based Solution-Focused Childbirth Preparation Education

  • Active comparator
    Control Group

    Participants in the control group will receive the standard antenatal education program provided by the Ministry of Health (Pregnancy School) during 28-32 weeks of gestation. The program will be delivered face-to-face in a group format once weekly for three weeks, consisting of a total of three sessions. Routine education will include information on pregnancy, preparation for childbirth, the postpartum period, newborn care, and breastfeeding.

    Behavioral: Standard Antenatal Education (Pregnancy School)

Interventions

  • BehavioralHealth 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 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.

  • BehavioralStandard Antenatal Education (Pregnancy School)

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

05

What researchers measure

Primary outcomes

  1. Fear of Childbirth (Wijma Delivery Expectancy/Experience Questionnaire - W-DEQ Version A and B)

    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.

    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.

  2. Belief in Normal Birth (Belief Scale for Vaginal Birth - BSVB)

    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).

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

Secondary outcomes

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

    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.

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

  2. Mode of Delivery

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

    Time frame: At delivery

06

Study locations

1 site
  • Ordu University
    Ordu, Turkey (Türkiye)
07

References and documents

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. PubMed 40033245 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared in order to protect participant confidentiality and privacy, in accordance with ethical approval and institutional policies.

08

Registry details

Key details

Study ID
NCT07549204
Lead sponsor
Ordu University
Responsible party
Seyhan ALPAY (PhD Candidate, Ordu University) — Principal investigator
First posted
Apr 24, 2026
Start date
May 15, 2026 (estimated)
Primary completion
Jul 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Apr 24, 2026

Study contacts

Seyhan ALPAY
Contact
seyhan.biber@gmail.com
+905388346698

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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