NCT07382609

Brief Summary

The aim of this study is to reduce the fears of women who will give birth and increase their comfort. In the literature review conducted for this purpose, no study has yet been found that examines the effect of creating a birth story in the labor room on the fear of birth and birth comfort in primiparous pregnant women. In order to fill this gap in the literature, pregnant women in the labor room will be asked to create their birth stories and the effect of this on fear of birth and birth comfort will be examined. The hypotheses of the study are as follows: H1a: Creating a birth story in the labor room affects fear of birth H1b: Creating a birth story in the labor room affects birth comfort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration 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

March 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

December 9, 2024

Last Update Submit

January 30, 2026

Conditions

Keywords

comfortfear of birthpregnant

Outcome Measures

Primary Outcomes (1)

  • Prenatal Self Evaluation Questionnaire score

    The scale developed by Lederman determines women's adaptation to pregnancy and motherhood. This scale is a 4-point Likert-type scale with 7 sub-dimensions and 79 items. The scores that can be obtained from the scale are between 10 and 40.

    Baseline (latent phase of labor) and prior to active labor (at 4 cm cervical dilatation)]

Secondary Outcomes (1)

  • Childbirth Comfort Questionnaire- CCQ score

    Immediately prior to active labor (at 4 cm cervical dilatation)

Study Arms (2)

No Intervention:

NO INTERVENTION

GROUP WITHOUT BIRTH STORY

Experimental

EXPERIMENTAL

Birth story creating group

Behavioral: BIRTH STORY EXPERIMENTAL GROUP

Interventions

The birth story is created by the pregnant women in the labor room writing their feelings on a transparent wallpaper attached to the wall. The pregnant woman, the midwife, the father and the doctor can also write their feelings and thoughts on this wallpaper. In this way, the pregnant woman looks at the wall on which positive thoughts are written throughout the labor and thus the fear of birth is reduced.

Experimental

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Over the age of 18,
  • Not experiencing a risky pregnancy,
  • Not becoming pregnant with assisted reproductive techniques,
  • Planned to have a vaginal birth,
  • In the latent phase of labor,
  • Do not have any psychiatric disorders,
  • Do not have any health problems in themselves or their babies,
  • Do not have a history of ex fetus will be included in the study.

You may not qualify if:

  • Pregnant women with an indication for caesarean section during the latent phase of labour will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Battalgazi̇, Turkey (Türkiye)

Location

Related Links

Study Officials

  • Esra GÜNEY, PhD

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Crossover Assignment randomized controlled trial conducted with experimental and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Student in Midwifery, Clinical Midwife

Study Record Dates

First Submitted

December 9, 2024

First Posted

February 3, 2026

Study Start

March 1, 2024

Primary Completion

November 1, 2025

Study Completion

January 15, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Research results will be shared.

Locations