NCT06155435

Brief Summary

Women's psycho-social health during pregnancy could influence the course of pregnancy, psychological and emotional life, not only in labor but also during the postpartum period. Women's perception of birth and their self-efficacy may affect the birth and postpartum period, and their delivery preference. The study aims to examine the effect of solution-oriented approach training on traumatic birth perception, vaginal birth selfefficacy, and delivery preference. It was designed in a randomized controlled experimental type. The sample in the study will comprise 80 pregnant women (40 experimental and 40 control groups) with the help of power analysis. The study is going to be conducted with pregnant women applying to KTU Farabi Hospital between May and December 2022. 6-8 sessions of solution-oriented approach training will be given to pregnant women with 28 weeks of gestation and above and willing to take part in the study, and their delivery preferences will be examined, afterward. The pregnant women in the control group, on the other hand, will not be subjected to any training or interview other than routine pregnancy follow-ups. Data will be gathered through the Pregnant introductory information form, traumatic birth perception scale form, and vaginal birth self-efficacy form. Ethics Committee Permission, institutional permission from the institution where the research will be conducted, and written informed consent from the mothers will be obtained before the research. The data will be statistically evaluated through the SPSS 23 program. Student t-test or Mann-Whitney U tests will be applied for two independent groups. One A Way or Kruskal-Wallis tests will be applied for three or more independent groups, depending on whether the data meet the parametric conditions. Paired T or Wilcoxon tests will be used for two dependent groups, and Friedman or Repeat Measure tests will be applied for three or more groups. In statistical evaluation, p\<0.05 will be considered significant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

April 23, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

November 19, 2023

Last Update Submit

August 27, 2025

Conditions

Keywords

pregnancyself efficacysolution-oriented approach trainingtraumatic birth perceptionvaginal birth

Outcome Measures

Primary Outcomes (2)

  • traumatic birth perception scale

    It was developed to measure the traumatic birth perception levels of women of reproductive age. There are a total of 13 questions in the scale. These questions; It includes the feelings and thoughts, anxiety, fear and trauma that a woman may experience when she thinks about giving birth. Answers to the questions were scored between 0 and 10, from "none at all" to "most". The total score obtained from the scale shows the level of perception of traumatic birth. The minimum scores that can be obtained from the scale are 0 and the maximum is 130. Total score averages indicate that the 0-26 point range is very low, the 27-52 point range is low, the 53-78 point range is medium, the 79-104 point range is high, and the 105-130 point range indicates that the woman has a very high level of perception of traumatic birth. The Cronbach Alpha reliability coefficient of the scale is 0.895.

    two months

  • vagınal bırth self-effıcacy

    This scale was developed to measure self-efficacy regarding vaginal birth during pregnancy. The scale consists of 9 items and there is an 11-point (0-10) numerical rating scale for each item. Scores range from 0 to 90, with higher scores indicating higher levels of self-efficacy. There are no items in the scale that need to be reverse coded. Cronbach's alpha coefficient, as a reliability criterion to determine the internal consistency of the scale, varies between 0.93 and 0.94.

    two months

Study Arms (2)

experimental group

EXPERIMENTAL

Firstly, the Pregnant Information Form, Traumatic Birth Perception Scale and Vaginal Birth Self-Efficacy Scale forms will be applied.Solution-oriented approach training; It is indicated for pregnant women one by one and in the form of at least 4 entries. A recording will take approximately 30-35 minutes.15-21 days after the solution-oriented approach training is completed the traumatic birth perception and vaginal birth self-efficacy scale form will be applied again.The traumatic birth perception form will be applied again 15-21 days after birth. The woman's birth type will be learned and recorded. 40 pregnant women will be followed in the experimental group.

Behavioral: solution focused approach training

control group

NO INTERVENTION

Firstly, the Pregnant Information Form, Traumatic Birth Perception Scale and Vaginal Birth Self-Efficacy Scale forms will be applied. will be no intervention on the pregnant women in the control group, and the 15-21st week after the prenatal care given to the pregnant women by the Ministry of Health is completed. Traumatic birth perception and vaginal birth self-efficacy scale form will be filled in on these days. The traumatic birth perception form will be applied again 15-21 days after birth. The woman's birth type will be learned and recorded. 40 pregnant women will be followed in the control group.

Interventions

To the woman; A list of education subjects will be sent in order to determine educational changes for birth, birth and postpartum periods. This list will be; It consists of reproductive organs, pregnancy formations, changes, psychological changes, daily life, nutrition, reproductive monitoring, immunization, frequent problems and solution suggestions, danger signs and what to do. Also included in the list are labor, birth cycle, and postpartum periods.

Also known as: Providing solution-oriented treatment training to pregnant women
experimental group

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Agreeing to participate in the research
  • Being over 20 years old
  • Being able to speak Turkish
  • Not having any disability such as hearing or vision
  • Being nulliparous pregnant
  • Being in the 3rd trimester (those who are pregnant between 28-35 weeks)
  • Not having received any psychiatric diagnosis before
  • No risk of vaginal bleeding, hypertension, diabetes, multiple pregnancy etc. during pregnancy.
  • Not having any physical/mental problems that would prevent normal birth.

You may not qualify if:

  • Pregnant women in high risk groups (arthritis, premature birth, placenta previa, etc.)
  • Multigravida pregnant women (pregnant women with 2 or more pregnancies)
  • Having received any psychiatric diagnosis and/or receiving psychiatric treatment.
  • The termination criteria for the cases included in the study will be as follows:
  • Intrauterine fetal death during pregnancy,
  • Emergence of any risk during pregnancy,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Teknik Üniversitesi

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Birth Injuries

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
There was one-way blinding in the randomization of this study. While it is known to the experimental or control class researcher of pregnant women, it can be done by the pregnant woman
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The experimental group was given solution-oriented training
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist midwife

Study Record Dates

First Submitted

November 19, 2023

First Posted

December 4, 2023

Study Start

April 23, 2023

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

September 4, 2025

Record last verified: 2025-08

Locations