Effects of Antenatal Education on Birth Perception, Fear, and Readiness (EA-BPFR)

March 24, 2025 updated by: Şahika ŞİMŞEK ÇETİNKAYA, Kastamonu University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Kastamonu, Turkey, 37150
        • Kastamonu

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be between the ages of 20-35
  • Be in the 30-32 weeks of gestation
  • Be a primigravida
  • Have at least basic literacy skills

Exclusion Criteria:

  • Have any chronic diseases
  • Have any psychiatric disorders
  • Be a high-risk pregnancy
  • Have any communication problems
  • Have communication issues

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transformational Learning-Based Antenatal Education Group
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
Behavioral: Transformational Learning-Based Antenatal Education Program
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.
No Intervention: Standard Antenatal Care Group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline: Week 30 of pregnancy (pre test); An average of 3 weeks (post test)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Childbirth Readiness
Time Frame: Baseline: Week 30 of pregnancy (pre test); An average of 3 weeks (post test)
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.
Baseline: Week 30 of pregnancy (pre test); An average of 3 weeks (post test)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kastamonu University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-KAEK-41

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

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings