NCT06637735

Brief Summary

During pregnancy, women are exposed to physical, psychological and social changes and may experience anxiety and fears about childbirth. Traumatic birth perception is defined as perceiving birth as a threat to oneself and one\'s baby. This perception can negatively affect women\'s lives in the postpartum period. Midwives are the primary health professionals in preventing traumatic birth perception. In this context, it is envisaged to create an important basis for preventing traumatic birth perception in pregnant women through the training to be given.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

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

Study Start

First participant enrolled

July 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

September 21, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

educationpregnancytraumatic childbirth

Outcome Measures

Primary Outcomes (1)

  • pre-test post-test

    The traumatic Childbirth Perception scale in pregnant women will be used as a pre-test and post-test. The experimental and control groups of the study will consist of pregnant women who scored at least 53 points on the Traumatic Childbirth Perception Scale. The minimum traumatic birth perception scale score is 0, and the maximum is 130. Scale total score 0-26 points range is very low, 27-52 points range is low, 53-78 points range is medium, 79-104 points range is high, and 105-130 points range is very high traumatic birth perception level.

    1 month

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group; pregnant women will receive a 4-week training

Other: education

control

NO INTERVENTION

No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group.

Interventions

pregnant women will be given a 4-week training and the pre-test post-test will be analyzed

Experimental group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age or older,
  • At least 53 points from the Traumatic Birth Perception Scale
  • No pregnancy-related risks (such as pre-eclampsia, diabetes, heart disease, placenta previa, oligohydramnios),
  • The fetus has no health problems (fetal anomaly, intrauterine growth retardation, etc.),
  • Literate,

You may not qualify if:

  • Illiterate,
  • Has a disorder based on a psychiatric/psychological diagnosis,
  • Pregnant women with communication and language problems will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Üniversity

Türkiye, Sakarya, 54000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Güleser ADA, Master

    sakarya üniversity

    STUDY CHAIR

Central Study Contacts

Güleser ADA, master

CONTACT

Kevser İLÇİOĞLU, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: experimental and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asisstant

Study Record Dates

First Submitted

September 21, 2024

First Posted

October 15, 2024

Study Start

July 1, 2024

Primary Completion

December 30, 2024

Study Completion

September 30, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations