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

April 17, 2026 updated by: Seyhan ALPAY, Ordu University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
Routine antenatal education provided by the Ministry of Health to pregnant women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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).
Baseline (28-32 weeks of gestation) and immediately after completion of the 3-week intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (28-32 weeks of gestation) and immediately after completion of the 3-week intervention.
Mode of Delivery
Time Frame: At delivery
Mode of delivery will be recorded as vaginal birth or cesarean section after childbirth.
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Abdelaziz, E. M., Alshammari, A. M., Elsharkawy, N. B., Oraby, F. A., & Ramadan, O. M. E. (2025). 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 and Childbirth, 25(1), 233.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PRIMIHBMRCT2026
  • 2025/31 (27 October 2025) (Other Identifier: Ordu University Non-Interventional Health Sciences Ethics Committee Approval)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared in order to protect participant confidentiality and privacy, in accordance with ethical approval and institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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