BreastfeedingNCT06918574
Breastfeeding Roadmap in Primiparous Women
A study testing Breastfeeding Education with Breastfeeding Roadmap in people with Breastfeeding and Self Efficacy, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The effect of the breastfeeding roadmap used in primiparous mothers on breastfeeding self-efficacy perception and breastfeeding success will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Self Efficacy
- What is being tested?
- Breastfeeding Education with Breastfeeding Roadmap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the study,
- Primiparous,
- Giving birth at 37 weeks of gestation or later,
- No condition preventing breastfeeding,
- No condition preventing breastfeeding in the baby,
- At least primary school graduate,
- Mothers aged 18 and over
Who cannot join
- Those who have given birth to multiple pregnancies,
- Those who received general anesthesia for Caesarean section,
- Those who have any chronic disease, diagnosed mental or psychiatric illness history,
- Those who have a history of preeclampsia, eclampsia and gestational diabetes,
- Those whose babies are in intensive care after birth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Faculty of Medicine Hospital
Konya
About this study
Official title: The Effect of Breastfeeding Roadmap on Breastfeeding Self-Efficacy Perception and Breastfeeding Success in Primiparous Women
The effect of the breastfeeding roadmap used in primiparous mothers on breastfeeding self-efficacy perception and breastfeeding success will be evaluated.
Read the detailed description
The research was planned as a randomized controlled experimental study. Mothers who meet the inclusion criteria and agree to participate in the study will be assigned to the intervention and control groups according to the randomization list.
A total of 74 primiparous mothers who gave birth, 37 in the intervention group and 37 in the control group, will be included in the study.
In addition to the routine breastfeeding education given by the clinic's education nurse, the mothers in the intervention group will also receive a "Breastfeeding Roadmap" education poster prepared by the researchers, which will be hung on the wall of their rooms. The researcher will introduce the Breastfeeding Roadmap to the mothers and provide information on breastfeeding. Routine hospital breastfeeding education will receive to mothers in the control group after childbirth.
Data Collection Pre-Test; Introductory Information Form, Breastfeeding Self-Efficacy Scale Short-Form, LATCH Breastfeeding Assessment Tool will be collected within the first hour after birth (before Breastfeeding Roadmap breastfeeding education and hospital routine breastfeeding education were implemented) Post-test; Breastfeeding Self-Efficacy Scale Short-Form, LATCH Breastfeeding Assessment Tool will be collected at least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours).
At the end of the study, the results of the mothers in the experimental and control groups will be evaluated.
- Conditions
- Breastfeeding, Self Efficacy
- Being tested
- Breastfeeding Education with Breastfeeding Roadmap
- Keywords
- Breastfeeding Roadmap
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding Education with Breastfeeding RoadmapOther
Information about the "Breastfeeding Roadmap" prepared by the researchers will be explained to the mothers in the intervention group and hung in poster rooms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In addition to the routine breastfeeding education given by the clinic's education nurse, the mothers in the intervention group will also receive a "Breastfeeding Roadmap" education poster prepared by the researchers, which will be hung on the wall of their rooms. The researcher will introduce the Breastfeeding Roadmap to the mothers and provide information on breastfeeding. Receives: Other: Breastfeeding Education with Breastfeeding Roadmap |
| Control group | No intervention | The control group of the study will receive routine breastfeeding education provided by the clinic's education nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic characteristics
Comparison of sociodemographic characteristics of women before the intervention with the questionnaire
Measured: Within the first hour after the mother's birth.
Breastfeeding Self-Efficacy Short Form Scale
Mothers whose pre-test data are collected will be assigned to intervention and control groups (Pre-test).
The scale consists of 14 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
Measured: Within the first hour after the mother's birth.
Breastfeeding Self-Efficacy Short Form Scale
Post-test data will be collected before mothers are discharged from the hospital (Post-test).
The scale consists of 14 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
Measured: At least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours)
LATCH Breastfeeding Assessment Tool
Mothers whose pre-test data are collected will be assigned to intervention and control groups (pre-test).
The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10. The higher the score obtained from the scale, the higher the breastfeeding success.
Measured: Within the first hour after the mother's birth
LATCH Breastfeeding Assessment Tool
Post-test data will be collected before mothers are discharged from the hospital (Post-test).
The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10. The higher the score obtained from the scale, the higher the breastfeeding success.
Measured: At least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Apr 2025
- Primary completion26 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Bekmezci, Selcuk University
- Investigators
- Ebru Bekmezci PhD, Principal investigator, Selcuk UniversityHediye Karakoç PhD, Principal investigator, KTO Karatay UniversityHalime Esra Meram PhD, Principal investigator, Selcuk UniversityJule Eriç Horasanlı Doctor, ASSOCIATE PROFESSOR, Principal investigator, Necmettin Erbakan University Medical Faculty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918574
- Sponsor's protocol ID
- 2024/048
- Status last verified
- Jul 2025
- First submitted
- 28 Mar 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baris E, Karakoc H, Meram HE, Horasanli JE. The Effect of a Breastfeeding Roadmap on Breastfeeding Self-Efficacy and Effective Breastfeeding in Primiparous Mothers. Breastfeed Med. 2026 Jul 23:15568253261470541. doi: 10.1177/15568253261470541. Online ahead of print.
PubMed 42489220
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Roadmap on Breastfeeding Self-Efficacy Perception and Breastfeeding Success in Primiparous Women
- ClinicalTrials.gov ID
- NCT06918574
- Acronym / sponsor ID
- 2024/048
- Conditions
- Breastfeeding, Self Efficacy
- Keywords
- Breastfeeding Roadmap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 26 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 9 Apr 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.
The effect of the breastfeeding roadmap used in primiparous mothers on breastfeeding self-efficacy perception and breastfeeding success will be evaluated.
Detailed description
The research was planned as a randomized controlled experimental study. Mothers who meet the inclusion criteria and agree to participate in the study will be assigned to the intervention and control groups according to the randomization list.
A total of 74 primiparous mothers who gave birth, 37 in the intervention group and 37 in the control group, will be included in the study.
In addition to the routine breastfeeding education given by the clinic's education nurse, the mothers in the intervention group will also receive a "Breastfeeding Roadmap" education poster prepared by the researchers, which will be hung on the wall of their rooms. The researcher will introduce the Breastfeeding Roadmap to the mothers and provide information on breastfeeding. Routine hospital breastfeeding education will receive to mothers in the control group after childbirth.
Data Collection Pre-Test; Introductory Information Form, Breastfeeding Self-Efficacy Scale Short-Form, LATCH Breastfeeding Assessment Tool will be collected within the first hour after birth (before Breastfeeding Roadmap breastfeeding education and hospital routine breastfeeding education were implemented) Post-test; Breastfeeding Self-Efficacy Scale Short-Form, LATCH Breastfeeding Assessment Tool will be collected at least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours).
At the end of the study, the results of the mothers in the experimental and control groups will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Breastfeeding Education with Breastfeeding RoadmapIn addition to the routine breastfeeding education given by the clinic's education nurse, the mothers in the intervention group will also receive a "Breastfeeding Roadmap" education poster prepared by the researchers, which will be hung on the wall of their rooms. The researcher will introduce the Breastfeeding Roadmap to the mothers and provide information on breastfeeding. |
| Control group | No intervention | –The control group of the study will receive routine breastfeeding education provided by the clinic's education nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteer to participate in the study,
- Primiparous,
- Giving birth at 37 weeks of gestation or later,
- No condition preventing breastfeeding,
- No condition preventing breastfeeding in the baby,
Key exclusion criteria (5 listed)
- Those who have given birth to multiple pregnancies,
- Those who received general anesthesia for Caesarean section,
- Those who have any chronic disease, diagnosed mental or psychiatric illness history,
- Those who have a history of preeclampsia, eclampsia and gestational diabetes,
- Those whose babies are in intensive care after birth
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 |
|---|---|---|
| Breastfeeding Education with Breastfeeding RoadmapInformation about the "Breastfeeding Roadmap" prepared by the researchers will be explained to the mothers in the intervention group and hung in poster rooms. | Other | Intervention group |
Primary outcome
Sociodemographic characteristics
Time frame: Within the first hour after the mother's birth.
Comparison of sociodemographic characteristics of women before the intervention with the questionnaire
Breastfeeding Self-Efficacy Short Form Scale
Time frame: Within the first hour after the mother's birth.
Mothers whose pre-test data are collected will be assigned to intervention and control groups (Pre-test). The scale consists of 14 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
Breastfeeding Self-Efficacy Short Form Scale
Time frame: At least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours)
Post-test data will be collected before mothers are discharged from the hospital (Post-test). The scale consists of 14 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
LATCH Breastfeeding Assessment Tool
Time frame: Within the first hour after the mother's birth
Mothers whose pre-test data are collected will be assigned to intervention and control groups (pre-test). The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10. The higher the score obtained from the scale, the higher the breastfeeding success.
LATCH Breastfeeding Assessment Tool
Time frame: At least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours)
Post-test data will be collected before mothers are discharged from the hospital (Post-test). The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10. The higher the score obtained from the scale, the higher the breastfeeding success.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Derived from this study: PubMed 42489220Baris E, Karakoc H, Meram HE, Horasanli JE. The Effect of a Breastfeeding Roadmap on Breastfeeding Self-Efficacy and Effective Breastfeeding in Primiparous Mothers. Breastfeed Med. 2026 Jul 23:15568253261470541. doi: 10.1177/15568253261470541. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Ebru Bekmezci PhD principal investigator
Selcuk University
Hediye Karakoç PhD principal investigator
KTO Karatay University
Halime Esra Meram PhD principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Education with Breastfeeding Roadmap in people with Breastfeeding and Self Efficacy, run by Selcuk 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 5 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: finished, as of the sponsor's last update on 31 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sociodemographic characteristics (time frame: Within the first hour after the mother's birth.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06918574, which also lists 1 linked publication.
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 31 Jul 2025.