FearPrimigravidaNCT07549204
HBM-Based Solution-Focused Birth Program on Fear of Childbirth in Primigravidas
A study testing Health Belief Model-Based Solution-Focused Childbirth Preparation Education and Standard Antenatal Education (Pregnancy School) in people with Fear and Stress (Psychology), run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear, Stress (Psychology), Pregnancy
- What is being tested?
- Health Belief Model-Based Solution-Focused Childbirth Preparation Education and Standard Antenatal Education (Pregnancy School)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ordu University
Ordu
Ebru Sahin, Associate Professor, PhD, 05062569764, ebrugabalci_@hotmail.com
About this study
Official 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
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.
- Conditions
- Fear, Stress (Psychology), Pregnancy
- Being tested
- Health Belief Model-Based Solution-Focused Childbirth Preparation Education, Standard Antenatal Education (Pregnancy School)
- Keywords
- Pregnancy, Fear, Health Belief Model, Solution-Focused Approach, Antenatal Education, Mode of Delivery, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Belief Model-Based Solution-Focused Childbirth Preparation EducationBehavioural
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)Behavioural
Routine antenatal education provided by the Ministry of Health to pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Antenatal Education (Pregnancy School) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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)
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.
Measured: Baseline (28-32 weeks of gestation) and immediately after completion of the 3-week intervention.
Mode of Delivery
Mode of delivery will be recorded as vaginal birth or cesarean section after childbirth.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhan ALPAY, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549204
- Sponsor's protocol ID
- PRIMIHBMRCT2026
- Other IDs
- 2025/31 (27 October 2025)
- Acronym
- Primigravida
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant confidentiality and privacy, in accordance with ethical approval and institutional policies.
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07549204
- Acronym / sponsor ID
- Primigravida / PRIMIHBMRCT2026
- Conditions
- Fear, Stress (Psychology), Pregnancy
- Keywords
- Pregnancy, Fear, Health Belief Model, Solution-Focused Approach, Antenatal Education, Mode of Delivery, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Health Belief Model-Based Solution-Focused Childbirth Preparation EducationParticipants 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. |
| Control Group | Active comparator | Behavioral: Standard Antenatal Education (Pregnancy School)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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Belief Model-Based Solution-Focused Childbirth Preparation EducationA 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. | Behavioural | Intervention Group |
| Standard Antenatal Education (Pregnancy School)Routine antenatal education provided by the Ministry of Health to pregnant women. | Behavioural | Control Group |
Primary outcome
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.
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).
2 secondary outcomes
Pregnancy Stress (Pregnancy Stress Rating Scale - PSRS)
Time frame: Baseline (28-32 weeks of gestation) and immediately after completion of the 3-week intervention.
Mode of Delivery
Time frame: At delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 40033245Abdelaziz 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Belief Model-Based Solution-Focused Childbirth Preparation Education and Standard Antenatal Education (Pregnancy School) in people with Fear and Stress (Psychology), run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seyhan ALPAY (+905388346698, seyhan.biber@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07549204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.