BreastfeedingNCT06341140
The Effect of Breastfeeding Support on Exclusive Breastfeeding, Occurrence of Breast Problems and Breastfeeding Self-Efficacy
A study testing Breastfeeding support and Booklet containing information about breastfeeding and Booklet containing information about breastfeeding in people with Breastfeeding and Breastfeeding, Exclusive, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to determine the effect of individual breastfeeding support on the lactation process. The research is a randomized controlled experimental study. The sample of the study consisted of pregnant women who applied to the Obstetrics Polyclinic of a university hospital (intervention=51, control=51). 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, Breastfeeding, Exclusive
- What is being tested?
- Breastfeeding support and Booklet containing information about breastfeeding and Booklet containing information about breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 6 Feb 2023
- 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
None listed.
Who cannot join
- At the beginning of the research;
- Under 18 years of age,
- Having a risky pregnancy,
- Having breastfeeding experience,
- Less than the 35th gestational week,
- Residing outside Manisa Central districts (Yunusemre and Şehzadeler),
Show all 13Show fewer
- Any maternal disability that may affect breastfeeding,
- Pregnant women who did not want to participate in the study were excluded.
- During the research process;
- Those who want to leave the job,
- If the baby has any obstacle that may affect breastfeeding (presence of anomaly, stay in intensive care, etc.),
- Cannot be reached within the first 5 days after birth,
- Mothers who changed their residence to live in another city/district other than Manisa Central districts (Yunusemre and Şehzadeler) were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Individualized Breastfeeding Support Make a Difference in Exclusive Breastfeeding, Breast Problem Occurrence, and Breastfeeding Self-Efficacy in the First 6 Months: Randomized Controlled Study
The aim of the study is to determine the effect of individual breastfeeding support on the lactation process. The research is a randomized controlled experimental study. The sample of the study consisted of pregnant women who applied to the Obstetrics Polyclinic of a university hospital (intervention=51, control=51). In the study, individual breastfeeding education was given to the intervention group during the antenatal period, and a training booklet was given to the control group. In the postpartum period, home visits and phone follow-ups were carried out for both groups between the fifth day and the sixth month. The effect of breastfeeding counseling on the lactation process; The duration of exclusive breastfeeding, breast problems and breastfeeding success was evaluated with. The data of the study were collected using the Pregnant, Postpartum-Newborn Information Form, Breastfeeding Questionnaire, Breast Problems Diagnosis Form, LATCH Breastfeeding Diagnostic Tool and Breastfeeding Self-Efficacy Scale.
- Conditions
- Breastfeeding, Breastfeeding, Exclusive
- Being tested
- Breastfeeding support and Booklet containing information about breastfeeding, Booklet containing information about breastfeeding
- 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 support and Booklet containing information about breastfeedingOther
Pregnant women in the intervention group were given individual counseling with a wearable breastfeeding model. During postnatal home visits, mothers were given support on breastfeeding, breast problems were addressed, and information was given to support the mother's self-efficacy.
Booklet containing information about breastfeedingOther
Pregnant women in the control group were given only a breastfeeding booklet, breastfeeding status, breast problems and breastfeeding self-efficacy were evaluated during postnatal home visits and telephone interviews, and risky situations were referred to health professionals.
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | Pregnant women in the control group were given a booklet containing information about breastfeeding. In the postpartum period, the breastfeeding process was observed with home visits and telephone for the first 6 months. Receives: Other: Booklet containing information about breastfeeding |
| intervention | Experimental | Pregnant women in the intervention group were given a booklet containing information about breastfeeding. At the same time, individual breastfeeding support was provided with a wearable breastfeeding model. In the postpartum period, the breastfeeding process was observed with home visits and telephone for the first 6 months. Receives: Other: Breastfeeding support and Booklet containing information about breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Situation of mothers feeding their babies exclusively with breast milk
Determination of mothers' status of exclusively breastfeeding their babies for the first 6 months using a survey form created by researchers.
Measured: 6 months
Mothers experiencing breast problems
Determination of breast problems that occur during the breastfeeding process with a survey created by researchers.
Measured: 6 months
Determination of mothers' breastfeeding self-efficacy
Breastfeeding competencies were assessed with the LATCH breastfeeding diagnostic tool and the breastfeeding self-efficacy scale. Mothers' breastfeeding success was examined with the LATCH breastfeeding diagnostic tool. On this scale, they can get a minimum of 0 and a maximum of 10 points. As the score increases, breastfeeding success increases. The breastfeeding self-efficacy scale determines the self-efficacy of mothers and can get a minimum of 33 and a maximum of 165 points. As the average score increases, breastfeeding self-efficacy is expressed as high.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Aug 2021
- Primary completion30 Nov 2022
- Study completion6 Feb 2023
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.
- 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
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seçil Köken Durgun, Manisa Celal Bayar University
- Investigators
- Seval Cambaz Ulaş, Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341140
- Sponsor's protocol ID
- secil koken
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Durgun SK, Ulas SC. The effect of individualized breastfeeding support on exclusive breastfeeding in the first 6 months, occurrence of breast problems and breastfeeding self-efficacy: randomized controlled study. BMC Pregnancy Childbirth. 2026 May 21;26(1):785. doi: 10.1186/s12884-026-09274-z.
PubMed 42168918
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Individualized Breastfeeding Support Make a Difference in Exclusive Breastfeeding, Breast Problem Occurrence, and Breastfeeding Self-Efficacy in the First 6 Months: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06341140
- Acronym / sponsor ID
- secil koken
- Conditions
- Breastfeeding, Breastfeeding, Exclusive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 2 Apr 2024 (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 aim of the study is to determine the effect of individual breastfeeding support on the lactation process. The research is a randomized controlled experimental study. The sample of the study consisted of pregnant women who applied to the Obstetrics Polyclinic of a university hospital (intervention=51, control=51). In the study, individual breastfeeding education was given to the intervention group during the antenatal period, and a training booklet was given to the control group. In the postpartum period, home visits and phone follow-ups were carried out for both groups between the fifth day and the sixth month. The effect of breastfeeding counseling on the lactation process; The duration of exclusive breastfeeding, breast problems and breastfeeding success was evaluated with. The data of the study were collected using the Pregnant, Postpartum-Newborn Information Form, Breastfeeding Questionnaire, Breast Problems Diagnosis Form, LATCH Breastfeeding Diagnostic Tool and Breastfeeding Self-Efficacy Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Other: Booklet containing information about breastfeedingPregnant women in the control group were given a booklet containing information about breastfeeding. In the postpartum period, the breastfeeding process was observed with home visits and telephone for the first 6 months. |
| intervention | Experimental | Other: Breastfeeding support and Booklet containing information about breastfeedingPregnant women in the intervention group were given a booklet containing information about breastfeeding. At the same time, individual breastfeeding support was provided with a wearable breastfeeding model. In the postpartum period, the breastfeeding process was observed with home visits and telephone for the first 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- At the beginning of the research;
- Under 18 years of age,
- Having a risky pregnancy,
- Having breastfeeding experience,
- Less than the 35th gestational week,
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 support and Booklet containing information about breastfeedingPregnant women in the intervention group were given individual counseling with a wearable breastfeeding model. During postnatal home visits, mothers were given support on breastfeeding, breast problems were addressed, and information was given to support the mother's self-efficacy. | Other | intervention |
| Booklet containing information about breastfeedingPregnant women in the control group were given only a breastfeeding booklet, breastfeeding status, breast problems and breastfeeding self-efficacy were evaluated during postnatal home visits and telephone interviews, and risky situations were referred to health professionals. | Other | control |
Primary outcome
Situation of mothers feeding their babies exclusively with breast milk
Time frame: 6 months
Determination of mothers' status of exclusively breastfeeding their babies for the first 6 months using a survey form created by researchers.
Mothers experiencing breast problems
Time frame: 6 months
Determination of breast problems that occur during the breastfeeding process with a survey created by researchers.
Determination of mothers' breastfeeding self-efficacy
Time frame: 6 months
Breastfeeding competencies were assessed with the LATCH breastfeeding diagnostic tool and the breastfeeding self-efficacy scale. Mothers' breastfeeding success was examined with the LATCH breastfeeding diagnostic tool. On this scale, they can get a minimum of 0 and a maximum of 10 points. As the score increases, breastfeeding success increases. The breastfeeding self-efficacy scale determines the self-efficacy of mothers and can get a minimum of 33 and a maximum of 165 points. As the average score increases, breastfeeding self-efficacy is expressed as high.
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 2 Apr 2024.
- Derived from this study: PubMed 42168918Durgun SK, Ulas SC. The effect of individualized breastfeeding support on exclusive breastfeeding in the first 6 months, occurrence of breast problems and breastfeeding self-efficacy: randomized controlled study. BMC Pregnancy Childbirth. 2026 May 21;26(1):785. doi: 10.1186/s12884-026-09274-z.
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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.
Seval Cambaz Ulaş principal investigator
Manisa Celal Bayar 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 support and Booklet containing information about breastfeeding and Booklet containing information about breastfeeding in people with Breastfeeding and Breastfeeding, Exclusive, run by Manisa Celal Bayar 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 0 inclusion and 13 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 2 Apr 2024. 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?
Situation of mothers feeding their babies exclusively with breast milk (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT06341140, 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 2 Apr 2024.