NCT06905821

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

March 21, 2025

Last Update Submit

March 24, 2025

Conditions

Keywords

Transformative Learningpregnancyfeartrauma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline: Week 30 of pregnancy (pre test); An average of 3 weeks (post test)

Secondary Outcomes (1)

  • Childbirth Readiness

    Baseline: Week 30 of pregnancy (pre test); An average of 3 weeks (post test)

Study Arms (2)

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

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.

Interventions

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.

Transformational Learning-Based Antenatal Education Group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu

Kastamonu, Kastamonu, 37150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Midwifery

Study Record Dates

First Submitted

March 21, 2025

First Posted

April 1, 2025

Study Start

June 1, 2024

Primary Completion

December 12, 2024

Study Completion

February 24, 2025

Last Updated

April 1, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations