Fear of ChildbirthNCT07188883
Development of Birth Perception Scale and Educational Intervention
A study testing Birth Education in people with Fear of Childbirth, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted in two phases. In the first phase, a psychometric instrument was developed and validated to measure women's perceptions of childbirth. The scale demonstrated strong reliability and validity indicators through exploratory and confirmatory factor analyses. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth
- What is being tested?
- Birth Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 3 Sep 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women aged 18 years or older
- Gestational age between 20-34 weeks at the time of enrollment
- Ability to read and understand Turkish
- Access to the internet and a device (computer, tablet, or smartphone) to attend online sessions
- Willingness to participate in a 9-hour online childbirth education program
- Provided written informed consent
Who cannot join
- High-risk pregnancy requiring specialized medical care (e.g., preeclampsia, placenta previa, multiple gestation with complications)
- Known psychiatric disorders that could interfere with participation (e.g., severe anxiety disorder, major depression, psychosis)
- Inability to attend online sessions due to technical or personal limitations
- Previous participation in a structured childbirth education program during the current pregnancy
- Refusal or withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Nursing
Izmir, 35100
About this study
Official title: Development of Ege Birth Perception Scale and the Effect of Planned Education on Birth Perception, Birth Fear and Birth Readiness
This study was conducted in two phases. In the first phase, a psychometric instrument was developed and validated to measure women's perceptions of childbirth. The scale demonstrated strong reliability and validity indicators through exploratory and confirmatory factor analyses.
In the second phase, a randomized controlled trial was designed to evaluate the effectiveness of a structured online education program on pregnant women's childbirth-related outcomes. A total of 80 pregnant women were recruited and randomly assigned to either the intervention group (n=40), which received a 9-hour online childbirth education program, or the control group (n=40), which received routine antenatal care.
Read more
The primary outcomes were childbirth perception, fear of childbirth, and readiness for birth, assessed at baseline and post-intervention using validated instruments. The results showed that the online education program significantly improved childbirth perception and readiness for birth while reducing fear of childbirth compared to the control group.
This trial provides evidence for the effectiveness of online antenatal education in promoting a positive childbirth experience and may contribute to improving maternal health outcomes in line with international recommendations for respectful maternity care.
- Conditions
- Fear of Childbirth
- Being tested
- Birth Education
- Keywords
- birth perception, fear of childbirth, birth readiness, scale development, birth preparation education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth EducationOther
The population consisted of all pregnant women between 24-36 weeks of gestation residing in Izmir province, and the study was completed with a total of 80 pregnant women, 40 pregnant women as intervention and 40 as control in line with the snowball sampling method. Ege Birth Perception Scale, Risk Assessment Form, Individual Introduction Form, Prenatal Self-Assessment Scale, Birth Education Evaluation Form were used to collect the data. Pregnant women who agreed to participate in the study were randomly divided into intervention and control groups; the intervention group received nine hours of online training, while the control group did not receive any intervention.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | pretest-posttest, randomized controlled quasi-experimental design intervention research Receives: Other: Birth Education |
| control group | No intervention | pretest-posttest, randomized controlled quasi-experimental design intervention research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth Perception Score
Measured: Measured by the validated Childbirth Perception Scale at baseline (before intervention) and 4 weeks after the intervention.
Fear of Childbirth Score
Measured: Measured by the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) at baseline and 4 weeks after the intervention.
Readiness for Birth Scor
Measured: Measured by the Childbirth Readiness Scale at baseline and 4 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of 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
- Model description
- pretest-posttest, randomized controlled quasi-experimental design intervention research
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin AHSUN, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188883
- Sponsor's protocol ID
- 22-7T/9
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Ege Birth Perception Scale and the Effect of Planned Education on Birth Perception, Birth Fear and Birth Readiness
- ClinicalTrials.gov ID
- NCT07188883
- Acronym / sponsor ID
- 22-7T/9
- Conditions
- Fear of Childbirth
- Keywords
- birth perception, fear of childbirth, birth readiness, scale development, birth preparation education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 23 Sep 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.
This study was conducted in two phases. In the first phase, a psychometric instrument was developed and validated to measure women's perceptions of childbirth. The scale demonstrated strong reliability and validity indicators through exploratory and confirmatory factor analyses.
In the second phase, a randomized controlled trial was designed to evaluate the effectiveness of a structured online education program on pregnant women's childbirth-related outcomes. A total of 80 pregnant women were recruited and randomly assigned to either the intervention group (n=40), which received a 9-hour online childbirth education program, or the control group (n=40), which received routine antenatal care.
The primary outcomes were childbirth perception, fear of childbirth, and readiness for birth, assessed at baseline and post-intervention using validated instruments. The results showed that the online education program significantly improved childbirth perception and readiness for birth while reducing fear of childbirth compared to the control group.
This trial provides evidence for the effectiveness of online antenatal education in promoting a positive childbirth experience and may contribute to improving maternal health outcomes in line with international recommendations for respectful maternity care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- pretest-posttest, randomized controlled quasi-experimental design intervention research
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Other: Birth Educationpretest-posttest, randomized controlled quasi-experimental design intervention research |
| control group | No intervention | –pretest-posttest, randomized controlled quasi-experimental design intervention research |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women aged 18 years or older
- Gestational age between 20-34 weeks at the time of enrollment
- Ability to read and understand Turkish
- Access to the internet and a device (computer, tablet, or smartphone) to attend online sessions
- Willingness to participate in a 9-hour online childbirth education program
Key exclusion criteria (5 listed)
- High-risk pregnancy requiring specialized medical care (e.g., preeclampsia, placenta previa, multiple gestation with complications)
- Known psychiatric disorders that could interfere with participation (e.g., severe anxiety disorder, major depression, psychosis)
- Inability to attend online sessions due to technical or personal limitations
- Previous participation in a structured childbirth education program during the current pregnancy
- Refusal or withdrawal of informed consent
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 |
|---|---|---|
| Birth EducationThe population consisted of all pregnant women between 24-36 weeks of gestation residing in Izmir province, and the study was completed with a total of 80 pregnant women, 40 pregnant women as intervention and 40 as control in line with the snowball sampling method. Ege Birth Perception Scale, Risk Assessment Form, Individual Introduction Form, Prenatal Self-Assessment Scale, Birth Education Evaluation Form were used to collect the data. Pregnant women who agreed to participate in the study were randomly divided into intervention and control groups; the intervention group received nine hours of online training, while the control group did not receive any intervention. | Other | intervention group |
Primary outcome
Childbirth Perception Score
Time frame: Measured by the validated Childbirth Perception Scale at baseline (before intervention) and 4 weeks after the intervention.
Fear of Childbirth Score
Time frame: Measured by the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) at baseline and 4 weeks after the intervention.
Readiness for Birth Scor
Time frame: Measured by the Childbirth Readiness Scale at baseline and 4 weeks after the intervention.
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 23 Sep 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 Birth Education in people with Fear of Childbirth, run by Ege 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 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 23 Sep 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?
Childbirth Perception Score (time frame: Measured by the validated Childbirth Perception Scale at baseline (before intervention) and 4 weeks after the intervention.). The study lists 3 primary outcomes in all. 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 23 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.