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Enrolling by invitationNCT07902271Updated Oct 28, 2026

The Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels

An interventional study of Hybrid-Model Breastfeeding Education in Breastfeeding and Postpartum Comfort, sponsored by Kutahya Health Sciences University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Nov 2025, registered Oct 2026).
Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Breastfeeding
  • Postpartum Comfort

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03

In context

Breast Feeding

1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.

This study's planned enrollment of 66 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Kutahya Health Sciences University is the lead sponsor of 219 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Having experienced a high-risk pregnancy.
  • Not being willing to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Behavioral: Hybrid-Model Breastfeeding Education

  • No intervention
    Control Group

Interventions

  • BehavioralHybrid-Model Breastfeeding Education

    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.

06

What researchers measure

Primary outcomes

  1. Breastfeeding Effectiveness

    Breastfeeding effectiveness will be assessed using the Bristol Breastfeeding Assessment Tool, which evaluates positioning, sucking, attachment, and swallowing.

    Time frame: Baseline, 24-48 hours after birth, and postpartum days 5, 15, and 30.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.

Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 12 months is close to that.

Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 28, 2026
StartActual
Nov 15, 2025
Primary completionEst.
Nov 15, 2026
CompletionEst.
Nov 15, 2026
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07902271
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Nov 15, 2025
Primary completion
Nov 15, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Oct 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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