NCT07268027

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

November 24, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

November 24, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

Pregnancy Education ProgramFear of ChildbirthPain BeliefSelf-Efficacy for Normal Birth

Outcome Measures

Primary Outcomes (5)

  • Comparison of the sociodemographic characteristics of pregnant women before the training with a survey.

    Sociodemographic information of pregnant women will be collected through surveys, compared, and reported.

    6 months

  • Comparison of obstetric characteristics of pregnant women before the training with a questionnaire.

    Obstetric data of pregnant women will be collected through questionnaires, compared, and reported.

    6 months

  • Comparison of the means of the Fear of Childbirth Scale among pregnant women across groups.

    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.

    6 months

  • Comparison of the Pain Beliefs Scale means among pregnant women across groups.

    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.

    6 months

  • Comparison of mean scores on the Self-Efficacy Scale for Normal Childbirth among pregnant women across groups.

    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.

    6 months

Study Arms (2)

No intervention

PLACEBO COMPARATOR

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.

Other: Constructivist-Based Prenatal Education Group

Intervention Group

EXPERIMENTAL

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: Constructivist-Based Prenatal Education Group

Interventions

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.

Also known as: Education Group
Intervention GroupNo intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seyhan Çankaya

Konya, 42250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Seyhan Çankaya, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Seyhan Çankaya

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

December 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations