NCT07121465

Brief Summary

This study aims to examine the effects of a breastfeeding and infant care education program, developed based on Mercer's Maternal Role Development Theory, on pregnant women's breastfeeding self-efficacy, readiness for infant care, and acceptance of the maternal role. The randomized controlled trial will be conducted with 142 pregnant women between 28 and 32 weeks of gestation who have not received any prior structured education. Data will be collected using the "Personal Information Form," the "Prenatal Breastfeeding-Self-Efficacy Scale," the "Pregnant Women's Readiness for Newborn Hygienic Care Scale," and the "Prenatal Self-Assessment Scale-Maternal Role Acceptance Subscale." Pregnant women in the experimental group will receive a two-session face-to-face education program (breastfeeding and infant care) based on Mercer's theory. One week after the training, participants will be asked to complete the same scales again. Project management included determining the sample size using G\*Power, conducting randomization, and analyzing the data using SPSS. The research will be conducted with ethics committee approval, and participant rights will be strictly adhered to. The broad impact of this study is that structured prenatal education can improve mothers' breastfeeding success and readiness for infant care, facilitating the transition to the motherhood role. The project, which aims to fill gaps in the literature, will contribute to both midwifery practice and evidence-based contributions to maternal and infant health.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

May 30, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

2 days

First QC Date

July 29, 2025

Last Update Submit

August 9, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pregnant Women's Readiness Scale for Newborn Hygienic Care

    The scale was developed by Çaka and Çınar in 2020 and consists of 10 items. The scale is a 7-point Likert-type scale, and each item is scored between 1 and 7, from "I'm not ready" to "I'm completely ready." The total scale score is obtained by summing the scores. The minimum score is 10 and the maximum score is 70. High scores indicate a high level of readiness for the pregnant woman. While the validity and reliability of the scale was conducted in primigravida pregnant women, it can also be used in multigravida pregnant women from the second trimester until birth. Scale score evaluation is as follows; 1-3 points: Not ready for hygienic care of the newborn, 4-5: Moderate readiness for hygienic care of the newborn, 6 and above: Readiness for hygienic care of the newborn. The Chronbach's Alpha value of the scale is 0.93 (Çaka et al., 2020).

    It was applied before and 1 week after the training.

  • Prenatal Breastfeeding-Self-Efficacy Scale

    It was developed by Wells et al. in 2006 to determine the perception of breastfeeding self-efficacy in pregnant women during the prenatal period (Wells et al., 2006). The validity and reliability of the Turkish version were conducted by Aydın and Pasinlioğlu. The Cronbach's Alpha value of the scale is 0.86. The scale consists of a total of 20 items. Each item of the scale is rated on a 5-point Likert-type scale: "1 = Not at all sure," "2 = Somewhat sure," 3 = Fairly sure," 4 = Very sure," and 5 = Absolutely sure." It has no sub-dimensions. It is evaluated based on a total score. The lowest score that can be obtained from the total scale is 20, and the highest score is 100. A higher score indicates an increase in the perception of breastfeeding self-efficacy (Aydın \& Pasinlioğlu, 2018).

    It was applied before and 1 week after the training.

  • Prenatal Self-Assessment Scale-Maternal Role Acceptance Subscale

    Developed by Lederman in 1979, it is a measurement tool used to assess pregnant women's adjustment to pregnancy and motherhood. The scale's validity and reliability study in Turkey was conducted by Beydağ and Mete (2008). The scale contains 7 subscales and 79 items. The internal consistency coefficient of the scale translated into Turkish was found to be Cronbach's alpha 0.81, and the internal consistency reliability coefficients of the subgroups ranged from 0.72 to 0.85 (Beydağ and Mete 2008). The 15-item Acceptance of the Motherhood Role subscale will be used in the study. Adjustment to pregnancy is assessed based on scores ranging from 1 to 4 (4: Very much describes, 3: Partially describes, 2: Somewhat describes, 1: Not at all describes). Scoring is reversed for reversed items. The lowest possible score from the maternal role acceptance subscale is 15, and the highest is 60. A low score indicates high compliance (Beydağ \& Mete, 2008).

    It was applied before and 1 week after the training.

Study Arms (2)

Education group

EXPERIMENTAL

First stage: Pregnant women will be administered a "Personal Information Form," the "Prenatal Breastfeeding-Self-Efficacy Scale," the "Prenatal Hygiene Care Readiness Scale," and the "Prenatal Self-Assessment Scale-Maternal Role Acceptance Subscale." Second stage: In this stage, pregnant women will be given a 60-minute breastfeeding education session. Third stage: This stage will take place one week after the second stage, and pregnant women will receive baby care training. The training will be conducted face-to-face in the training room of the hospital where the study will be conducted, using the training manual prepared by the researchers according to Mercer's theory as a guide. Fourth stage: In this stage, pregnant women will again be administered the "Prenatal Breastfeeding-Self-Efficacy Scale," the "Prenatal Hygiene Care Readiness Scale," and the "Prenatal Self-Assessment Scale-Maternal Role Acceptance Subscale."

Behavioral: Education groupBehavioral: Control group

Control group

NO INTERVENTION

Pregnant women who have not received training will be included in this group.

Interventions

Education groupBEHAVIORAL

First stage: Pregnant women will be administered a "Personal Information Form," the "Prenatal Breastfeeding-Self-Efficacy Scale," the "Prenatal Hygiene Care Readiness Scale," and the "Prenatal Self-Assessment Scale-Maternal Role Acceptance Subscale." Second stage: In this stage, pregnant women will be given a 60-minute breastfeeding education session. Third stage: This stage will take place one week after the second stage, and pregnant women will receive baby care training. The training will be conducted face-to-face in the training room of the hospital where the study will be conducted, using the training manual prepared by the researchers according to Mercer's theory as a guide. Fourth stage: In this stage, pregnant women will again be administered the "Prenatal Breastfeeding-Self-Efficacy Scale," the "Prenatal Hygiene Care Readiness Scale," and the "Prenatal Self-Assessment Scale-Maternal Role Acceptance Subscale."

Education group
Control groupBEHAVIORAL

First stage: In this stage, pregnant women will be informed about the study and their voluntary written consent will be obtained. They will then complete a Personal Information Form, the Prenatal Breastfeeding Self-Efficacy Scale, the Prenatal Hygienic Care Readiness Scale, and the Prenatal Self-Assessment Scale-Maternal Role Acceptance Subscale. Second stage: Pregnant women will be administered the Prenatal Breastfeeding Self-Efficacy Scale, the Prenatal Hygienic Care Readiness Scale, and the Prenatal Self-Assessment Scale-Maternal Role Acceptance Subscale.

Education group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women who volunteered to participate in the study were:
  • years old,
  • Primiparous,
  • Able to speak and understand Turkish,
  • weeks pregnant,
  • Singleton pregnant,
  • Having not received any structured education during pregnancy.

You may not qualify if:

  • Pregnant women with diagnosed mental health problems,
  • Those with high-risk pregnancies,
  • Those with communication problems,
  • Those who do not wish to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Bilim Üniversitesi

Antalya, 07080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 13, 2025

Study Start

May 30, 2025

Primary Completion

June 1, 2025

Study Completion

December 28, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The study will be shared after it is published.

Locations