ChildbirthEA-BPFRNCT06905821
Effects of Antenatal Education on Birth Perception, Fear, and Readiness
A study testing Transformational Learning-Based Antenatal Education Program in people with Childbirth and Fear, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Birth is a multi-dimensional and unique experience for every woman, and it is influenced by a woman's social life. Fear of childbirth is a common issue that affects women's health and well-being before, during, and after pregnancy. The thought that childbirth will be painful triggers fear of childbirth. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth, Fear
- What is being tested?
- Transformational Learning-Based Antenatal Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 24 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 20-35
- Be in the 30-32 weeks of gestation
- Be a primigravida
- Have at least basic literacy skills
Who cannot join
- Have any chronic diseases
- Have any psychiatric disorders
- Be a high-risk pregnancy
- Have any communication problems
- Have communication issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Antenatal Education Based on Transformative Learning Theory on Traumatic Birth Perception, Fear of Birth, and Birth Readiness in Pregnant Women: a Randomized Controlled Trial
Birth is a multi-dimensional and unique experience for every woman, and it is influenced by a woman's social life. Fear of childbirth is a common issue that affects women's health and well-being before, during, and after pregnancy. The thought that childbirth will be painful triggers fear of childbirth. Fear of childbirth is closely related to the perception of traumatic birth. Antenatal education is important in coping with childbirth pain and traumatic birth pain, but the aim of adult education is not just to inform, but also to change individuals' perspectives on events. The transformative learning theory is a model used to change individuals' perspectives on events. The aim of this study was to investigate the effect of antenatal education based on the transformative learning theory on traumatic birth perception, fear of childbirth, and birth preparedness in pregnant women. The study was conducted as a randomized controlled trial with 54 participants. Data collection forms included a personal information form, the Traumatic Birth Perception Scale, the Prenatal Self-Assessment Scale, and the Wijma Birth Expectancy/Experience Scale. The Statistical Package for the Social Sciences 23.0 (Chicago, Illinois) version was used for data analysis. Histogram and Q-Q plots, and the Shapiro-Wilk test were used to assess the normality of the data distribution. Descriptive data regarding women's demographic characteristics were analyzed using frequencies, percentages, and mean values. Differences in demographic characteristics between groups were examined using the independent sample t-test, Mann-Whitney U test, and Chi-square test. Pre-test and post-test scores of the groups were analyzed using the independent sample t-test. A significance level of p<0.05 was accepted.
- Conditions
- Childbirth, Fear
- Being tested
- Transformational Learning-Based Antenatal Education Program
- Keywords
- Transformative Learning, pregnancy, fear, trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transformational Learning-Based Antenatal Education ProgramBehavioural
The Transformational Learning-Based Antenatal Education Program helps pregnant women reduce birth-related anxiety and fear by utilizing transformational learning theory. Unlike traditional antenatal education, it emphasizes psychological preparedness, focusing on emotional well-being and coping strategies. The program includes interactive learning, group discussions, and self-reflection to engage participants actively. This approach aims to boost women's confidence and reduce stress as they approach labor and delivery.
| Study group | Role | What they receive |
|---|---|---|
| Transformational Learning-Based Antenatal Education Group | Experimental | This group will receive antenatal education based on transformational learning theory. The program aims to reduce birth fear and traumatic birth perception by providing participants with targeted information and strategies. Participants will gain knowledge and coping mechanisms to manage pain, stress, and anxiety during labor. The education will focus on raising awareness about the birth process, promoting psychological preparedness, and supporting post-birth recovery, all aimed at enhancing overall birth experience and well-being Receives: Behavioral: Transformational Learning-Based Antenatal Education Program |
| Standard Antenatal Care Group | No intervention | This group will receive standard antenatal care, which includes routine check-ups and general health education related to pregnancy. Participants will not receive the transformational learning-based antenatal education or any specific intervention related to birth fear or traumatic birth perception. The standard care focuses on general information about the physiological process of pregnancy and labor but does not address psychological preparedness or provide strategies for managing birth-related anxiety or fear. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of Traumatic Birth
This will be assessed using the Traumatic Birth Perception Scale.The scale, developed by Yalnız et al. (2016), is called the Traumatic Birth Perception Scale. It is designed to assess the traumatic birth perception levels of women of reproductive age. It consists of 13 items that encompass the thoughts and emotions, such as anxiety, fear, and concern, that a woman experiences when thinking about childbirth. For each item, respondents rate their feelings on a scale from 0 ("no fear") to 10 ("extreme fear"). The total average score indicates the level of traumatic birth perception. The lowest and highest possible scores on the scale are 0 and 130, respectively. As the score increases, it reflects a higher perception of traumatic birth. The score ranges are as follows: 0-26 indicates very low, 27-52 low, 53-78 moderate, 79-104 high, and 105-130 indicates very high levels of traumatic birth perception. The Cronbach's alpha reliability coefficient of the scale is 0.89.
Measured: Baseline: Week 30 of pregnancy (pre test); An average of 3 weeks (post test)
Secondary outcomes (1)
Childbirth Readiness
The Childbirth Readiness Subscale (PKDÖ-DHOÖ) was developed by Lederman in 1979 to assess women's adaptation to motherhood during the prenatal period. The scale, consisting of 79 items and using a 4-point Likert-type scale, was validated and tested for reliability in Turkey by Beydağ and Mete (2008). The scale includes 7 subscales: thoughts about the health of oneself and the baby, acceptance of pregnancy, acceptance of the maternal role, childbirth readiness, fear of childbirth, relationship with the mother, and relationship with the spouse. These subscales can be used independently. The general Cronbach's alpha for the Turkish version of the scale is 0.81, and the internal consistency reliability coefficients for the subgroups range from 0.72 to 0.85 (Beydağ \& Mete, 2008). Scores on the scale range from 10 to 40. The Cronbach's alpha value for the Childbirth Readiness Subscale (DHOÖ) is 0.72. As the score increases, it indicates a lower level of readiness for childbirth.
Measured: Baseline: Week 30 of pregnancy (pre test); An average of 3 weeks (post test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Jun 2024
- Primary completion12 Dec 2024
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildbirthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şahika ŞİMŞEK ÇETİNKAYA, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905821
- Sponsor's protocol ID
- 2023-KAEK-41
- Acronym
- EA-BPFR
- Status last verified
- Jun 2024
- First submitted
- 21 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antenatal Education Based on Transformative Learning Theory on Traumatic Birth Perception, Fear of Birth, and Birth Readiness in Pregnant Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06905821
- Acronym / sponsor ID
- EA-BPFR / 2023-KAEK-41
- Conditions
- Childbirth, Fear
- Keywords
- Transformative Learning, pregnancy, fear, trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 1 Apr 2025 (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.
Birth is a multi-dimensional and unique experience for every woman, and it is influenced by a woman's social life. Fear of childbirth is a common issue that affects women's health and well-being before, during, and after pregnancy. The thought that childbirth will be painful triggers fear of childbirth. Fear of childbirth is closely related to the perception of traumatic birth. Antenatal education is important in coping with childbirth pain and traumatic birth pain, but the aim of adult education is not just to inform, but also to change individuals' perspectives on events. The transformative learning theory is a model used to change individuals' perspectives on events. The aim of this study was to investigate the effect of antenatal education based on the transformative learning theory on traumatic birth perception, fear of childbirth, and birth preparedness in pregnant women. The study was conducted as a randomized controlled trial with 54 participants. Data collection forms included a personal information form, the Traumatic Birth Perception Scale, the Prenatal Self-Assessment Scale, and the Wijma Birth Expectancy/Experience Scale. The Statistical Package for the Social Sciences 23.0 (Chicago, Illinois) version was used for data analysis. Histogram and Q-Q plots, and the Shapiro-Wilk test were used to assess the normality of the data distribution. Descriptive data regarding women's demographic characteristics were analyzed using frequencies, percentages, and mean values. Differences in demographic characteristics between groups were examined using the independent sample t-test, Mann-Whitney U test, and Chi-square test. Pre-test and post-test scores of the groups were analyzed using the independent sample t-test. A significance level of p<0.05 was accepted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transformational Learning-Based Antenatal Education Group | Experimental | Behavioral: Transformational Learning-Based Antenatal Education ProgramThis group will receive antenatal education based on transformational learning theory. The program aims to reduce birth fear and traumatic birth perception by providing participants with targeted information and strategies. Participants will gain knowledge and coping mechanisms to manage pain, stress, and anxiety during labor. The education will focus on raising awareness about the birth process, promoting psychological preparedness, and supporting post-birth recovery, all aimed at enhancing overall birth experience and well-being |
| Standard Antenatal Care Group | No intervention | –This group will receive standard antenatal care, which includes routine check-ups and general health education related to pregnancy. Participants will not receive the transformational learning-based antenatal education or any specific intervention related to birth fear or traumatic birth perception. The standard care focuses on general information about the physiological process of pregnancy and labor but does not address psychological preparedness or provide strategies for managing birth-related anxiety or fear. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be between the ages of 20-35
- Be in the 30-32 weeks of gestation
- Be a primigravida
- Have at least basic literacy skills
Key exclusion criteria (5 listed)
- Have any chronic diseases
- Have any psychiatric disorders
- Be a high-risk pregnancy
- Have any communication problems
- Have communication issues
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 |
|---|---|---|
| Transformational Learning-Based Antenatal Education ProgramThe Transformational Learning-Based Antenatal Education Program helps pregnant women reduce birth-related anxiety and fear by utilizing transformational learning theory. Unlike traditional antenatal education, it emphasizes psychological preparedness, focusing on emotional well-being and coping strategies. The program includes interactive learning, group discussions, and self-reflection to engage participants actively. This approach aims to boost women's confidence and reduce stress as they approach labor and delivery. | Behavioural | Transformational Learning-Based Antenatal Education Group |
Primary outcome
Perception of Traumatic Birth
Time frame: Baseline: Week 30 of pregnancy (pre test); An average of 3 weeks (post test)
This will be assessed using the Traumatic Birth Perception Scale.The scale, developed by Yalnız et al. (2016), is called the Traumatic Birth Perception Scale. It is designed to assess the traumatic birth perception levels of women of reproductive age. It consists of 13 items that encompass the thoughts and emotions, such as anxiety, fear, and concern, that a woman experiences when thinking about childbirth. For each item, respondents rate their feelings on a scale from 0 ("no fear") to 10 ("extreme fear"). The total average score indicates the level of traumatic birth perception. The lowest and highest possible scores on the scale are 0 and 130, respectively. As the score increases, it reflects a higher perception of traumatic birth. The score ranges are as follows: 0-26 indicates very low, 27-52 low, 53-78 moderate, 79-104 high, and 105-130 indicates very high levels of traumatic birth perception. The Cronbach's alpha reliability coefficient of the scale is 0.89.
1 secondary outcome
Childbirth Readiness
Time frame: Baseline: Week 30 of pregnancy (pre test); An average of 3 weeks (post test)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transformational Learning-Based Antenatal Education Program in people with Childbirth and Fear, run by Kastamonu 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 1 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of Traumatic Birth (time frame: Baseline: Week 30 of pregnancy (pre test); An average of 3 weeks (post test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.