- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268027
Constructivist Prenatal Education Effects
May 22, 2026 updated by: Seyhan Çankaya, Selcuk University
The Effect of a Constructivist-Based Prenatal Education Program on Pregnant Women's Fear of Childbirth, Pain Beliefs, and Self-Efficacy for Normal Delivery: A Randomized Controlled Trial.
The Effect of a Constructivist-Based Prenatal Education Program on Pregnant Women's Fear of Childbirth, Pain Beliefs, and Self-Efficacy for Normal Delivery: A Randomized Controlled Trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study is a randomized controlled trial.
It will be conducted at the prenatal school of Konya City Hospital between December 2025 and May 2026.
A total of 126 primiparous pregnant women will be included in the study (intervention group n=63, control group n=63).
The intervention group will receive the Constructivist-Based Prenatal Education Program, while the control group will receive the standard prenatal care and education provided by the hospital.
Data will be collected using a personal information form, the Fear of Childbirth Scale, the Pain Beliefs Scale, and the Self-Efficacy for Normal Birth Scale.
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Konya, Turkey (Türkiye), 42250
- Seyhan Çankaya
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Registered in the hospital's prenatal school and actively participating in the 3-day training sessions,
- Aged 18 years or older,
- Between 20 and 32 weeks of gestation,
- Having a singleton and low-risk pregnancy,
- Primiparous (expecting their first birth),
- Voluntarily agreeing to participate by signing the written informed consent form,
- Able to read, understand, and communicate in Turkish.
Exclusion Criteria:
- Those who have previously given birth vaginally or by cesarean section (multiparous women),
- Those with multiple pregnancies,
- Those who conceived through assisted reproductive techniques,
- Those diagnosed with serious obstetric or medical complications during pregnancy (such as preeclampsia, gestational diabetes, or risk of preterm birth),
- Those with a history of psychiatric diagnosis or currently receiving psychiatric treatment,
- Foreign nationals.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Placebo Comparator: No intervention
No additional intervention will be provided to the control group beyond the information they receive during routine prenatal care and in-service trainings, and the control group will consist of pregnant women who do not attend the prenatal school education.
After the study is completed, control group participants will be offered the opportunity to attend the standard prenatal school education if they wish.
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Pregnant women who agree to participate in the study and are assigned to the childbirth preparation education group will receive a Constructivist-Based Prenatal Education Program in the prenatal school department of the hospital for a total of 24 hours over 3 days.
Participants in the intervention group will attend the classes in groups of 15.
Other Names:
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Experimental: Intervention Group
Pregnant women who agree to participate in the study and are assigned to the childbirth preparation education group will receive a Constructivist-Based Prenatal Education Program in the prenatal school department of the hospital for a total of 24 hours over 3 days.
Participants in the intervention group will attend the classes in groups of 15.
|
Pregnant women who agree to participate in the study and are assigned to the childbirth preparation education group will receive a Constructivist-Based Prenatal Education Program in the prenatal school department of the hospital for a total of 24 hours over 3 days.
Participants in the intervention group will attend the classes in groups of 15.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of the sociodemographic characteristics of pregnant women before the training with a survey.
Time Frame: 6 months
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Sociodemographic information of pregnant women will be collected through surveys, compared, and reported.
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6 months
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Comparison of obstetric characteristics of pregnant women before the training with a questionnaire.
Time Frame: 6 months
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Obstetric data of pregnant women will be collected through questionnaires, compared, and reported.
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6 months
|
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Comparison of the means of the Fear of Childbirth Scale among pregnant women across groups.
Time Frame: 6 months
|
The Fear of Childbirth Scale will be administered to pregnant women.
The Respectful Childbirth Care scale ranges from 0 to 160 points (min-max), with higher scores indicating higher fear of childbirth.
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6 months
|
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Comparison of the Pain Beliefs Scale means among pregnant women across groups.
Time Frame: 6 months
|
The Pain Beliefs Scale will be administered to pregnant women.The scale evaluates two types of pain-related beliefs: organic and psychological.
It includes 12 items rated on a 6-point Likert scale, with 8 items assessing organic beliefs (pain as a physiological or pathophysiological condition) and 4 items assessing psychological beliefs (pain influenced by anxiety, depression, or external factors).
No total score is calculated; each subscale score is the mean of its items.
Higher scores indicate stronger beliefs in that specific dimension.
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6 months
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Comparison of mean scores on the Self-Efficacy Scale for Normal Childbirth among pregnant women across groups.
Time Frame: 6 months
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The Self-Efficacy Scale for Normal Childbirth will be administered to pregnant women.
Possible scores on the scale are 0-90 (min-max).
Higher scores indicate higher self-efficacy levels.
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2025
Primary Completion (Actual)
March 1, 2026
Study Completion (Actual)
March 1, 2026
Study Registration Dates
First Submitted
November 24, 2025
First Submitted That Met QC Criteria
November 24, 2025
First Posted (Actual)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 22, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/1052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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