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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Pregnancy, Breastfeeding, Infant Care, Newborn Care, Theory, Maternal 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 group | Role | What they receive |
|---|---|---|
| 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." Receives: Behavioral: Education group; Behavioral: Control group |
| Control group | No intervention | Pregnant 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.
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.
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.
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.
- First posted13 Aug 2025
- Study start30 May 2025
- Primary completion1 Jun 2025
- Study completion28 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Antalya Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07121465
- Acronym / sponsor ID
- ABU-007
- Conditions
- Pregnancy, Breastfeeding, Infant Care, Newborn Care, Theory, Maternal Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Antalya Bilim UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Behavioral: Education group, Behavioral: Control groupFirst 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 group | No intervention | –Pregnant women who have not received training will be included in this group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education groupFirst 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." | Behavioural | Education group |
| Control groupFirst 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. | Behavioural | Education group |
Primary outcome
Pregnant Women's Readiness Scale for Newborn Hygienic Care
Time frame: It was applied before and 1 week after the training.
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).
Prenatal Breastfeeding-Self-Efficacy Scale
Time frame: It was applied before and 1 week after the training.
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).
Prenatal Self-Assessment Scale-Maternal Role Acceptance Subscale
Time frame: It was applied before and 1 week after the training.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No. The study will be shared after it is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.