BreastfeedingNCT07902271
The Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels
A study testing Hybrid-Model Breastfeeding Education in people with Breastfeeding and Postpartum Comfort, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Effect of Hybrid Breastfeeding Education on Breastfeeding Effectiveness and Postpartum Comfort 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, Postpartum Comfort
- What is being tested?
- Hybrid-Model Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 15 Nov 2026
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous women (women giving birth for the first time).
- Having given birth vaginally.
- Having no obstetric, gynecological, or medical diseases.
- Having a healthy newborn.
- Being willing to participate in the study.
- Having an average score of 3 or lower on the Postpartum Comfort Questionnaire.
- Being able to read and write Turkish.
Who cannot join
- Having experienced a high-risk pregnancy.
- Not being willing to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kütahya Health Science University
Kütahya, 43000
About this study
Official title: The Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels: A Randomized Controlled Study
Effect of Hybrid Breastfeeding Education on Breastfeeding Effectiveness and Postpartum Comfort
Read the detailed description
This randomized controlled study aims to determine the effect of hybrid-model breastfeeding education on breastfeeding effectiveness and postpartum comfort levels among primiparous women following vaginal birth.
The study will be conducted in the postpartum ward of Bilecik Training and Research Hospital between November 15, 2025, and November 15, 2026. The planned sample size is 66 women, with 33 participants assigned to the intervention group and 33 to the control group. Eligible participants will be randomly allocated to the study groups using the Randomizer website.
The inclusion criteria are being primiparous, having had a vaginal birth, having no obstetric, gynecological, or medical disease, having a healthy newborn, being willing to participate in the study, being able to read and write Turkish, and having an average postpartum comfort score of 3 or lower.
The intervention group will receive breastfeeding education using a hybrid model. The educational intervention will consist of a breastfeeding education brochure prepared by the researcher and reinforced through remote follow-up. The educational content will address breastfeeding practices and techniques. Education will be repeated until adequate feedback is obtained from the participant to demonstrate understanding of the information. Additional breastfeeding education will be provided by telephone on postpartum days 5, 15, and 30.
Participants in the control group will receive routine care provided in the study setting without the additional breastfeeding education intervention. Both groups will be assessed at baseline, 24-48 hours after birth, and on postpartum days 5, 15, and 30.
Data will be collected using a Personal Information Form, the Bristol Breastfeeding Assessment Tool, and the Postpartum Comfort Questionnaire. The Personal Information Form will collect sociodemographic, obstetric, and other relevant participant characteristics. Breastfeeding effectiveness will be assessed using the Bristol Breastfeeding Assessment Tool, which evaluates positioning, sucking, attachment, and swallowing. Postpartum comfort will be assessed using the Postpartum Comfort Questionnaire.
The primary purpose of the study is to evaluate whether hybrid-model breastfeeding education improves breastfeeding effectiveness and postpartum comfort compared with routine care. Outcomes will be assessed by comparing measurements between the intervention and control groups and examining changes over time.
The findings are expected to contribute to evidence regarding the effectiveness of hybrid-model breastfeeding education in supporting breastfeeding practices and improving postpartum comfort during the first month after childbirth.
- Conditions
- Breastfeeding, Postpartum Comfort
- Being tested
- Hybrid-Model Breastfeeding Education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid-Model Breastfeeding EducationBehavioural
The intervention consists of hybrid-model breastfeeding education provided to women in the intervention group. The education will be delivered using a breastfeeding education brochure prepared by the researcher and reinforced through telephone-based follow-up. The educational content will address breastfeeding practices and techniques. Education will be repeated until adequate feedback is obtained from participants to confirm their understanding. Additional breastfeeding education will be provided by telephone on postpartum days 5, 15, and 30. Breastfeeding effectiveness and postpartum comfort will be assessed at baseline, 24-48 hours after birth, and on postpartum days 5, 15, and 30 using the Bristol Breastfeeding Assessment Tool and the Postpartum Comfort Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Hybrid-Model Breastfeeding Education |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Effectiveness
Breastfeeding effectiveness will be assessed using the Bristol Breastfeeding Assessment Tool, which evaluates positioning, sucking, attachment, and swallowing.
Measured: Baseline, 24-48 hours after birth, and postpartum days 5, 15, and 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start15 Nov 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Care provider
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902271
- Sponsor's protocol ID
- E-41997688-050.99-207783
- Status last verified
- Nov 2025
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07902271
- Acronym / sponsor ID
- E-41997688-050.99-207783
- Conditions
- Breastfeeding, Postpartum Comfort
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 28 Oct 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.
Effect of Hybrid Breastfeeding Education on Breastfeeding Effectiveness and Postpartum Comfort
Detailed description
This randomized controlled study aims to determine the effect of hybrid-model breastfeeding education on breastfeeding effectiveness and postpartum comfort levels among primiparous women following vaginal birth.
The study will be conducted in the postpartum ward of Bilecik Training and Research Hospital between November 15, 2025, and November 15, 2026. The planned sample size is 66 women, with 33 participants assigned to the intervention group and 33 to the control group. Eligible participants will be randomly allocated to the study groups using the Randomizer website.
The inclusion criteria are being primiparous, having had a vaginal birth, having no obstetric, gynecological, or medical disease, having a healthy newborn, being willing to participate in the study, being able to read and write Turkish, and having an average postpartum comfort score of 3 or lower.
The intervention group will receive breastfeeding education using a hybrid model. The educational intervention will consist of a breastfeeding education brochure prepared by the researcher and reinforced through remote follow-up. The educational content will address breastfeeding practices and techniques. Education will be repeated until adequate feedback is obtained from the participant to demonstrate understanding of the information. Additional breastfeeding education will be provided by telephone on postpartum days 5, 15, and 30.
Participants in the control group will receive routine care provided in the study setting without the additional breastfeeding education intervention. Both groups will be assessed at baseline, 24-48 hours after birth, and on postpartum days 5, 15, and 30.
Data will be collected using a Personal Information Form, the Bristol Breastfeeding Assessment Tool, and the Postpartum Comfort Questionnaire. The Personal Information Form will collect sociodemographic, obstetric, and other relevant participant characteristics. Breastfeeding effectiveness will be assessed using the Bristol Breastfeeding Assessment Tool, which evaluates positioning, sucking, attachment, and swallowing. Postpartum comfort will be assessed using the Postpartum Comfort Questionnaire.
The primary purpose of the study is to evaluate whether hybrid-model breastfeeding education improves breastfeeding effectiveness and postpartum comfort compared with routine care. Outcomes will be assessed by comparing measurements between the intervention and control groups and examining changes over time.
The findings are expected to contribute to evidence regarding the effectiveness of hybrid-model breastfeeding education in supporting breastfeeding practices and improving postpartum comfort during the first month after childbirth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Hybrid-Model Breastfeeding Education |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Primiparous women (women giving birth for the first time).
- Having given birth vaginally.
- Having no obstetric, gynecological, or medical diseases.
- Having a healthy newborn.
- Being willing to participate in the study.
Key exclusion criteria (2 listed)
- Having experienced a high-risk pregnancy.
- Not being willing 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 |
|---|---|---|
| Hybrid-Model Breastfeeding EducationThe intervention consists of hybrid-model breastfeeding education provided to women in the intervention group. The education will be delivered using a breastfeeding education brochure prepared by the researcher and reinforced through telephone-based follow-up. The educational content will address breastfeeding practices and techniques. Education will be repeated until adequate feedback is obtained from participants to confirm their understanding. Additional breastfeeding education will be provided by telephone on postpartum days 5, 15, and 30. Breastfeeding effectiveness and postpartum comfort will be assessed at baseline, 24-48 hours after birth, and on postpartum days 5, 15, and 30 using the Bristol Breastfeeding Assessment Tool and the Postpartum Comfort Questionnaire. | Behavioural | Intervention Group |
Primary outcome
Breastfeeding Effectiveness
Time frame: Baseline, 24-48 hours after birth, and postpartum days 5, 15, and 30.
Breastfeeding effectiveness will be assessed using the Bristol Breastfeeding Assessment Tool, which evaluates positioning, sucking, attachment, and swallowing.
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 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Hybrid-Model Breastfeeding Education in people with Breastfeeding and Postpartum Comfort, run by Kutahya Health Sciences 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 2 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: enrolling by invitation, as of the sponsor's last update on 28 Oct 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?
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?
Breastfeeding Effectiveness (time frame: Baseline, 24-48 hours after birth, and postpartum days 5, 15, and 30.). 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 28 Oct 2026.