NCT05928117

Brief Summary

Pregnancy and childbirth are a natural life event for women, as well as a process in which physical, biological and psychosocial changes are experienced. This process causes women to perceive childbirth as an unknown and unpredictable situation, resulting in the fear of childbirth. Due to the fear of childbirth, the daily routines, professional lives, social activities and relationships of pregnant women are significantly affected. This study was planned to evaluate the effect of mobile education given in line with the "Guide to Coping with Fear of Birth" on fear of birth, birth preference and maternal satisfaction at birth. Research; It will be carried out at the T. C. Ministry of Health Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital. Data; The first one is 28-30th of pregnancy. week, the second is 36-38. It will meet in three meetings in total, the third of which will be within 12-24 hours postpartum. Data, Personal Information Form (Annex-1), Wijma Birth Expectation/Experience Scale (W-DEQ) Version A (Annex-2), Wijma Birth Expectation/Experience Scale Version B (Annex-3) and Birth Experience Scale ( Annex-4) and Postpartum Questionnaire (Annex-5). The obtained data will be analyzed with the SPSS 22.0 program. In this study, it is thought that the training given to women with a high level of birth fear can reduce their fear of childbirth and increase maternal satisfaction at birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

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

August 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

June 23, 2023

Last Update Submit

September 7, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fear of birth

    As the scale score increases, the fear of birth increases

    Pre-test: Wijma Birth Fear/Experience version A and B were applied between 28-30 weeks of pregnancy. Post-test: Wijma Birth Fear/Experience version A and B were applied between 36-38 weeks.

  • Birth experience

    As the score obtained from the scale increases, the mother has a good birth experience.

    Birth experience scale was applied between 12-24 hour

Study Arms (2)

Experimental

EXPERIMENTAL

Intervention: Mobile education given in the line of coping with fear The first one is 28-30th of pregnancy. week, the second is 36-38. It will meet in three meetings in total, the third of which will be within 12-24 hours postpartum.

Other: Education

Control

NO INTERVENTION

Standart care

Interventions

Pregnant women will be given training to cope with the fear of childbirth.

Also known as: Training to cope with the fear of childbirth education
Experimental

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous,
  • Having a single fetus,
  • Able to read and write,
  • Between the ages of 18-35,
  • Volunteer to participate in the research,
  • days of pregnancy according to the last menstrual period or ultrasonography records. in the week,
  • No risk factors (heart disease, placenta previa, oligohydramnios, preeclampsia, anhydramnios, diabetes, epilepsy),
  • Having a telephone that can be contacted for mobile calls,
  • Pregnant women who do not have any disability diagnosed for normal delivery.

You may not qualify if:

  • Having communication problems,
  • Having mental deficiency,
  • Those who received infertility treatment and became pregnant with assisted reproductive techniques.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Meltem Akbaş, PhD

    Universty Of Cukurova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Experimental and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations