Breastfeeding DifficultiesNCT07496307
Structured Breastfeeding Education In Infants With Breast Refusal
A study testing Structured Breastfeeding Education in people with Breastfeeding Difficulties and Maternal Breastfeeding Motivation, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to examine the effects of structured breastfeeding education supported by midwives on the sucking skills of infants experiencing nipple refusal, maternal breastfeeding motivation, and mother-infant bonding. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Difficulties, Maternal Breastfeeding Motivation, Nipple Refusal
- What is being tested?
- Structured Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 6 Sep 2026
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mothers with infants aged 1-4 months
- Mothers of infants who have experienced nipple refusal for 3-30 days
- Mothers who provide written informed consent
- Mothers without pregnancy or postpartum complications
- Mothers who are literate and able to understand the study questionnaires
Who cannot join
- Infants with serious congenital anomalies or health problems
- Mothers with severe psychiatric or chronic illnesses
- Any medical condition in the mother or infant that prevents participation
- Mothers who refuse to complete the study or cannot comply with the follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kafkas University Training and Research Hospital
Kars, Kars, 36100
About this study
Official title: The Impact Of Structured Breastfeeding Education On Sucking Function, Breastfeeding Motivation, And Mother-Infant Attachment In Infants With Breast Refusal: A Randomized Controlled Trial
This randomized controlled trial aims to examine the effects of structured breastfeeding education supported by midwives on the sucking skills of infants experiencing nipple refusal, maternal breastfeeding motivation, and mother-infant bonding. The study will be conducted with mothers who have infants aged 1-4 months and have been experiencing nipple refusal for at least 3 days and up to 30 days. Participants will be randomly assigned to either the intervention or control group; the intervention group will receive a one-week structured breastfeeding education program, while the control group will receive standard care. Following the education, online support will be provided for 15 days, and breastfeeding observations will be monitored. Sucking skills of the infants, mother-infant bonding, and maternal breastfeeding motivation will be assessed at both baseline and post-intervention evaluations.
Read the detailed description
This study will be conducted as a randomized controlled trial to determine the effects of structured breastfeeding education on the sucking skills of infants experiencing nipple refusal, maternal breastfeeding motivation, and mother-infant bonding. Participants will include mothers with infants aged 1-4 months who have experienced nipple refusal for 3 to 30 days. Written informed consent will be obtained from all participating mothers, and they will be randomly assigned to either the intervention or control group.
Mothers in the intervention group will receive structured breastfeeding education through individual or group sessions lasting one hour per day for one week. The education will cover topics such as nipple refusal, benefits of breast milk, breastfeeding techniques, methods to increase milk production, skin-to-skin contact, the importance of mother-infant bonding, and motivation-enhancing strategies. Following the education, participants will receive online support for 15 days, and breastfeeding progress will be monitored through daily observation forms.
The control group will receive only standard medical care, and an educational brochure will be provided after the study is completed. At baseline, mothers' demographic and obstetric information, infants' sucking skills, mother-infant bonding, and maternal breastfeeding motivation will be assessed. At the end of the education and follow-up period, a post-intervention evaluation will be conducted on day 16 using the same measurements, and the results will be compared.
This study aims to determine whether structured breastfeeding education improves the sucking skills of infants experiencing nipple refusal, strengthens mother-infant bonding, and positively influences maternal breastfeeding motivation.
- Conditions
- Breastfeeding Difficulties, Maternal Breastfeeding Motivation, Nipple Refusal, Mother-infant Bonding
- Being tested
- Structured Breastfeeding Education
- Keywords
- Breastfeeding, Nipple refusal, breastfeeding motivation, Infant feeding skills, Mother-infant bonding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Breastfeeding EducationBehavioural
One-week, midwife-supported structured breastfeeding education for mothers of infants experiencing nipple refusal. Includes guidance on breastfeeding techniques, nipple refusal management, milk production enhancement, skin-to-skin contact, mother-infant bonding, and motivation strategies. Followed by 15 days of online support and daily breastfeeding monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Structured Breastfeeding Education | Experimental | Mothers in this group will receive a one-week structured breastfeeding education program with midwife support. The education includes guidance on nipple refusal, breastfeeding techniques, methods to increase milk production, skin-to-skin contact, importance of mother-infant bonding, and strategies to enhance maternal breastfeeding motivation. Following the program, participants will receive daily online support for 15 days, and breastfeeding progress will be monitored through daily observation forms. Receives: Behavioral: Structured Breastfeeding Education |
| Routine Postpartum Care | No intervention | Mothers in the control group will receive routine medical care and standard postnatal guidance provided by the hospital. No structured breastfeeding education or additional intervention will be provided during the study period. After completion of the study, participants will be given educational materials (brochure). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Motivation Scale (for Primiparous Mothers)
Breastfeeding motivation will be assessed using the Breastfeeding Motivation Scale (BMS), developed by Peleg et al. (2015) and adapted into Turkish by Mızrak (2017). The scale consists of 23 items rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). The scale does not yield a total score; instead, subscale scores are calculated as the mean of the items. Higher scores indicate higher motivation in the respective subscale.
Measured: From the start of the intervention to 16 days
Secondary outcomes (1)
Maternal Attachment (Measured by Maternal Attachment Scale)
Maternal attachment will be assessed using the Maternal Attachment Scale (Maternal Bağlanma Ölçeği, MBÖ) developed by Muller (1994) and adapted into Turkish by Kavlak and Şirin (2009).
The scale consists of 26 items rated on a 4-point Likert scale (1 = never, 4 = always). Total scores range from 26 to 104. Higher scores indicate higher maternal attachment.
Measured: 16 days after the start of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Nov 2025
- Primary completion15 Jan 2026
- Study completion6 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding DifficultiesStudies 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
- Model description
- Participants will be randomly assigned to two parallel groups: an intervention group receiving one-week structured breastfeeding education supported by midwives, and a control group receiving standard care. Both groups will be followed concurrently, and outcomes including infant sucking skills, maternal breastfeeding motivation, and mother-infant bonding will be compared at baseline and post-intervention.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel GÜÇLÜ CİHAN, Kahramanmaras Sutcu Imam University
- Investigators
- Emel Güçlü Cihan, Assistant Professor, Principal investigator, Kafkas University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496307
- Sponsor's protocol ID
- MR-EM-8182-74
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data from this study will not be shared publicly due to privacy and confidentiality concerns. Data include sensitive information about mothers and their infants, and sharing identifiable data could compromise participant privacy. Aggregate study results will be shared in publications and reports.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Structured Breastfeeding Education On Sucking Function, Breastfeeding Motivation, And Mother-Infant Attachment In Infants With Breast Refusal: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07496307
- Acronym / sponsor ID
- MR-EM-8182-74
- Conditions
- Breastfeeding Difficulties, Maternal Breastfeeding Motivation, Nipple Refusal, Mother-infant Bonding
- Keywords
- Breastfeeding, Nipple refusal, breastfeeding motivation, Infant feeding skills, Mother-infant bonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 6 Sep 2026 (actual)
- First posted
- 27 Mar 2026 (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 randomized controlled trial aims to examine the effects of structured breastfeeding education supported by midwives on the sucking skills of infants experiencing nipple refusal, maternal breastfeeding motivation, and mother-infant bonding. The study will be conducted with mothers who have infants aged 1-4 months and have been experiencing nipple refusal for at least 3 days and up to 30 days. Participants will be randomly assigned to either the intervention or control group; the intervention group will receive a one-week structured breastfeeding education program, while the control group will receive standard care. Following the education, online support will be provided for 15 days, and breastfeeding observations will be monitored. Sucking skills of the infants, mother-infant bonding, and maternal breastfeeding motivation will be assessed at both baseline and post-intervention evaluations.
Detailed description
This study will be conducted as a randomized controlled trial to determine the effects of structured breastfeeding education on the sucking skills of infants experiencing nipple refusal, maternal breastfeeding motivation, and mother-infant bonding. Participants will include mothers with infants aged 1-4 months who have experienced nipple refusal for 3 to 30 days. Written informed consent will be obtained from all participating mothers, and they will be randomly assigned to either the intervention or control group.
Mothers in the intervention group will receive structured breastfeeding education through individual or group sessions lasting one hour per day for one week. The education will cover topics such as nipple refusal, benefits of breast milk, breastfeeding techniques, methods to increase milk production, skin-to-skin contact, the importance of mother-infant bonding, and motivation-enhancing strategies. Following the education, participants will receive online support for 15 days, and breastfeeding progress will be monitored through daily observation forms.
The control group will receive only standard medical care, and an educational brochure will be provided after the study is completed. At baseline, mothers' demographic and obstetric information, infants' sucking skills, mother-infant bonding, and maternal breastfeeding motivation will be assessed. At the end of the education and follow-up period, a post-intervention evaluation will be conducted on day 16 using the same measurements, and the results will be compared.
This study aims to determine whether structured breastfeeding education improves the sucking skills of infants experiencing nipple refusal, strengthens mother-infant bonding, and positively influences maternal breastfeeding motivation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two parallel groups: an intervention group receiving one-week structured breastfeeding education supported by midwives, and a control group receiving standard care. Both groups will be followed concurrently, and outcomes including infant sucking skills, maternal breastfeeding motivation, and mother-infant bonding will be compared at baseline and post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Structured Breastfeeding Education | Experimental | Behavioral: Structured Breastfeeding EducationMothers in this group will receive a one-week structured breastfeeding education program with midwife support. The education includes guidance on nipple refusal, breastfeeding techniques, methods to increase milk production, skin-to-skin contact, importance of mother-infant bonding, and strategies to enhance maternal breastfeeding motivation. Following the program, participants will receive daily online support for 15 days, and breastfeeding progress will be monitored through daily observation forms. |
| Routine Postpartum Care | No intervention | –Mothers in the control group will receive routine medical care and standard postnatal guidance provided by the hospital. No structured breastfeeding education or additional intervention will be provided during the study period. After completion of the study, participants will be given educational materials (brochure). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Mothers with infants aged 1-4 months
- Mothers of infants who have experienced nipple refusal for 3-30 days
- Mothers who provide written informed consent
- Mothers without pregnancy or postpartum complications
- Mothers who are literate and able to understand the study questionnaires
Key exclusion criteria (4 listed)
- Infants with serious congenital anomalies or health problems
- Mothers with severe psychiatric or chronic illnesses
- Any medical condition in the mother or infant that prevents participation
- Mothers who refuse to complete the study or cannot comply with the follow-up
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 |
|---|---|---|
| Structured Breastfeeding EducationOne-week, midwife-supported structured breastfeeding education for mothers of infants experiencing nipple refusal. Includes guidance on breastfeeding techniques, nipple refusal management, milk production enhancement, skin-to-skin contact, mother-infant bonding, and motivation strategies. Followed by 15 days of online support and daily breastfeeding monitoring. | Behavioural | Structured Breastfeeding Education |
Primary outcome
Breastfeeding Motivation Scale (for Primiparous Mothers)
Time frame: From the start of the intervention to 16 days
Breastfeeding motivation will be assessed using the Breastfeeding Motivation Scale (BMS), developed by Peleg et al. (2015) and adapted into Turkish by Mızrak (2017). The scale consists of 23 items rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). The scale does not yield a total score; instead, subscale scores are calculated as the mean of the items. Higher scores indicate higher motivation in the respective subscale.
1 secondary outcome
Maternal Attachment (Measured by Maternal Attachment Scale)
Time frame: 16 days after the start of the intervention.
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 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data from this study will not be shared publicly due to privacy and confidentiality concerns. Data include sensitive information about mothers and their infants, and sharing identifiable data could compromise participant privacy. Aggregate study results will be shared in publications and reports.
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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.
Emel Güçlü Cihan, Assistant Professor principal investigator
Kafkas University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Breastfeeding Education in people with Breastfeeding Difficulties and Maternal Breastfeeding Motivation, run by Kahramanmaras Sutcu Imam 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 5 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: finished, as of the sponsor's last update on 17 Sep 2026. 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?
Breastfeeding Motivation Scale (for Primiparous Mothers) (time frame: From the start of the intervention to 16 days). 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 17 Sep 2026.