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| ID | Type | Description | Link |
|---|---|---|---|
| 2025/31 (27 October 2025) | Other Identifier | Ordu University Non-Interventional Health Sciences Ethics Committee Approval |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (28-32 weeks of gestation) and immediately after completion of the 3-week intervention. |
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Inclusion Criteria:
Exclusion Criteria:
Female, pregnant woman
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seyhan ALPAY | Contact | +905388346698 | seyhan.biber@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordu University | Ordu | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40033245 | Background | 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. |
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Individual participant data will not be shared in order to protect participant confidentiality and privacy, in accordance with ethical approval and institutional policies.
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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.
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| Standard Antenatal Education (Pregnancy School) | Behavioral | Routine antenatal education provided by the Ministry of Health to pregnant women. |
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| Mode of Delivery |
Mode of delivery will be recorded as vaginal birth or cesarean section after childbirth. |
| At delivery |