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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06155435
Other study ID # KTU-SABE-TYT-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 23, 2023
Est. completion date May 31, 2024

Study information

Verified date May 2024
Source Karadeniz Technical University
Contact Tugba Yazici Topçu
Phone +905535718551
Email tibiyzc@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
solution focused approach training
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.

Locations

Country Name City State
Turkey Karadeniz Teknik Üniversitesi Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary vaginal birth self-efficacy 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
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