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

NCT07549204 | Not Yet Recruiting

• 2 other identifiers: PRIMIHBMRCT20262025/31 (27 October 2025)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fear; Stress (Psychology); Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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 Outcomes (2)

• Pregnancy Stress (Pregnancy Stress Rating Scale - PSRS)

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

• Mode of Delivery

  At delivery

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

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.

Intervention Group

Standard Antenatal Education (Pregnancy School) BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Female, pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University

Ordu, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  BACKGROUND

Central Study Contacts

Seyhan ALPAY

CONTACT

+905388346698; seyhan.biber@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: Participants will be randomly assigned to either an intervention group or a control group in a parallel design. 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 routine antenatal care provided by the Ministry of Health. Outcomes will be assessed at baseline, after the intervention, and in the postpartum period.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)