NCT06348329

Brief Summary

In this prospective, randomized controlled study, it was aimed to examine the effect of pregnant women participating in birth preparation training together with their partners on the parenting role, spouses' attitudes towards participation in birth, and birth self-efficacy. The study was shared via the web on social media (Facebook, Instagram, Twitter, Telegram) forum pages between 25.09.2023-25.03.2025, and n=158 pregnant women who met the inclusion criteria and volunteered to participate in the study (79= education without spouse participation, 79= spouse Participatory education) will be conducted randomly in two groups: case and control. Before starting the research, two groups will be randomly formed among pregnant women. As a randomization method, pregnant women who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumber-generator.aspx).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 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

June 29, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

March 30, 2024

Last Update Submit

January 29, 2025

Conditions

Keywords

Birth Preparation Training

Outcome Measures

Primary Outcomes (4)

  • Parenting behavior evaluated using the Postpartum Parenting Behavior Scale

    It is used to evaluate the parenting behavior of parents towards the baby during their first encounter with their baby after birth. The scale can only be applied to parents in the first minutes after birth. Britton et al. It was developed by Çalışır et al. Turkish validity and reliability were conducted by. The scale, which consists of items such as close contact, touching with affection, examining the baby, talking with affection, positive comments and happiness, is evaluated in a binary scoring manner by marking these items as present/absent. Each item is evaluated as one (1) point if the behavior is observed, and zero (0) point if the behavior is not observed. The total scale score consists of the sum of the numbers obtained from each item. The total score of the scale is between 0-6 points. A higher total score from the scale indicates that the parent has more positive parenting behavior towards his/her baby.

    change from baseline implamentation patent and after training and 1st month after birth of practice

  • Parenting self-efficacy in labor evaluated using the Self-Efficacy in Labor Scale

    he Turkish validity and reliability study of the scale, which measures women's self-confidence and coping ability regarding labor, was conducted by Ersoy. The scale has two sub-dimensions: outcome and competence expectation. Each sub-dimension of the scale consists of 16 questions. The lowest score to be obtained from the scale sub-dimensions is 16 and the highest score is 160. High scores from the subscales indicate that pregnant women have high expectations of adequacy and outcome regarding birth. Responses on a Likert-type scale are scored from 1 to 10.

    change from baseline implamentation patent and after training and 1st month after birth of practice

  • Spouse support evaluated using the Spouse Support Scale

    The scale developed by Yıldırım (2004) is used to measure the support spouses receive from each other. The scale consists of a total of 27 questions, and there are 3 reversed items (10,20,24). The scale has a three-point rating; It is shown as Suitable for Me=3, Partially Suitable for Me=2, Not Suitable for Me=1. Just like straight items, reversed items are scored in reverse. The scale has four factors. The first factor is 'emotional support' (6,16,12,21,4,1,3,9,2) consisting of nine items, and the second factor is 'financial aid and information support' (24,17,27,25,13,7, 15) consists of seven items, the third factor 'appreciation support' (18,10,5,26,14,22,23,20) consists of eight items, and the fourth factor 'social interest support' (19,11,8) consists of three items. The score that can be obtained from EDS varies between 27-81. The lower the score, the less support, the higher the score, the more support. The Cronbach Alpha coefficient of the scale is stated as 0.95.

    change from baseline implamentation patent and after training and 1st month after birth of practice

  • Father candidates towards participating in the birth evaluated using the Attitude Scale for Father Candidates Towards Participating in the Birth

    The scale developed by Çiçek Özdemir and Kan in 2022 is used to evaluate the attitudes of father candidates towards attending the birth. The scale consists of 26 items and is a five-point Likert type. The reactions of the prospective fathers who answered the scale to the items are measured with five options for positive statements, depending on their degree of agreement: completely agree = 5, agree = 4, undecided = 3, disagree = 2, completely disagree = 1. The scale contains 18 positive items and 8 negative items. Negative expressions are coded by reversing. The scale consists of three subscales: Positive Emotions Towards Participating in Birth, Negative Emotions Towards Participating in Birth, and Actions Towards Participating in Birth.

    change from baseline implamentation patent and after training and 1st month after birth of practice

Study Arms (2)

education without co-participation

EXPERIMENTAL
Other: Birth Preparation Training

education with co-participation

EXPERIMENTAL
Other: Birth Preparation Training

Interventions

Birth Preparation Training is planned to include a 4-week program by an internationally certified instructor.

education with co-participationeducation without co-participation

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Over the age of 18, the mother and the baby must not have any health problems during pregnancy, birth and postpartum period, do not have a previously diagnosed mental disorder, must attend the Birth Preparation Class (BPC) with their spouses for the group receiving co-participation training and continue for 4 weeks. For the education group without partner participation, pregnant women who do not participate in the Birth Preparation Class (BPC) with their partners and continue for 4 weeks and who volunteer to participate in the study will be included in the study.

You may not qualify if:

  • Under the age of 18, having a health problem in the mother and the baby during pregnancy, birth and postpartum period, having a previously diagnosed mental disorder, not participating in the Birth Preparation Class (BPC) with their spouses for the group receiving training with partner participation and not attending the Birth Preparation Class (DHS) for 4 weeks. For the training group without partner participation, participation in the Birth Preparation Class (BPC) with their spouses and non-attendance for 4 weeks, and non-pregnant women will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 4, 2024

Study Start

June 29, 2023

Primary Completion

October 15, 2023

Study Completion

December 15, 2024

Last Updated

January 30, 2025

Record last verified: 2025-01

Locations