AzTrials
AzTrials

PregnancyNCT07121465

The Effect of a Breastfeeding and Infant Care Education Program Prepared According to Mercer Theory on Breastfeeding Self-Efficacy, Readiness for Infant Care, and Acceptance of the Maternal Role

A study testing Education group in people with Pregnancy and Breastfeeding, run by Antalya Bilim University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Breastfeeding, Infant Care
What is being tested?
Education group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 May 2025to 28 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant women who volunteered to participate in the study were:
  • 18-35 years old,
  • Primiparous,
  • Able to speak and understand Turkish,
  • 28-32 weeks pregnant,
  • Singleton pregnant,
  • Having not received any structured education during pregnancy.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Antalya Bilim Üniversitesi

    Antalya, 07080

Other trials in Turkey (Türkiye)

About this study

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.

Being tested
Education group, Control group
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education groupBehavioural

    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."

  • Control groupBehavioural

    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.

Study groups in NCT07121465
Study groupRoleWhat they receive
Education groupExperimentalFirst 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."
Receives: Behavioral: Education group; Behavioral: Control group
Control groupNo interventionPregnant women who have not received training will be included in this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: It was applied before and 1 week after the training.

  2. 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).

    Measured: It was applied before and 1 week after the training.

  3. 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).

    Measured: It was applied before and 1 week after the training.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2025
  2. Study start30 May 2025
  3. Primary completion1 Jun 2025
  4. Study completion28 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07121465
Sponsor's protocol ID
ABU-007
Status last verified
Aug 2025
First submitted
29 Jul 2025
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study will be shared after it is published.

Questions about this trial

What is this clinical trial studying?

A study testing Education group in people with Pregnancy and Breastfeeding, run by Antalya Bilim University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pregnant Women's Readiness Scale for Newborn Hygienic Care (time frame: It was applied before and 1 week after the training.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in