- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07188883
- Original Trial
Development of Birth Perception Scale and Educational Intervention
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.
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 Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Izmir, Turkey (Türkiye), 35100
- Ege University Faculty of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: intervention group
pretest-posttest, randomized controlled quasi-experimental design intervention research
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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.
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No Intervention: control group
pretest-posttest, randomized controlled quasi-experimental design intervention research
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Childbirth Perception Score
Time Frame: Measured by the validated Childbirth Perception Scale at baseline (before intervention) and 4 weeks after the intervention.
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Measured by the validated Childbirth Perception Scale at baseline (before intervention) and 4 weeks after the intervention.
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Fear of Childbirth Score
Time Frame: Measured by the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) at baseline and 4 weeks after the intervention.
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Measured by the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) at baseline and 4 weeks after the intervention.
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Readiness for Birth Scor
Time Frame: Measured by the Childbirth Readiness Scale at baseline and 4 weeks after the intervention.
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Measured by the Childbirth Readiness Scale at baseline and 4 weeks after the intervention.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 22-7T/9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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