NCT07188883

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

September 16, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

birth perceptionfear of childbirthbirth readinessscale developmentbirth preparation education

Outcome Measures

Primary Outcomes (3)

  • Childbirth Perception Score

    Measured by the validated Childbirth Perception Scale at baseline (before intervention) and 4 weeks after the intervention.

  • Fear of Childbirth Score

    Measured by the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) at baseline and 4 weeks after the intervention.

  • Readiness for Birth Scor

    Measured by the Childbirth Readiness Scale at baseline and 4 weeks after the intervention.

Study Arms (2)

intervention group

ACTIVE COMPARATOR

pretest-posttest, randomized controlled quasi-experimental design intervention research

Other: Birth Education

control group

NO INTERVENTION

pretest-posttest, randomized controlled quasi-experimental design intervention research

Interventions

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.

intervention group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Nursing

Izmir, 35100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pretest-posttest, randomized controlled quasi-experimental design intervention research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 23, 2025

Study Start

January 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 3, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations