Breast FeedingPABEPNCT06493474
Peer Assisted Breastfeeding Education Program
A study testing Education and Routine Care in people with Breast Feeding, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to evaluate the effect of the Peer Supported Breastfeeding Education Program given during the antenatal period on the breastfeeding knowledge and attitude levels, breastfeeding self-efficacy and breastfeeding levels of postpartum women. For this purpose, the hypotheses created in our study are as follows. Read more about this study
- Who is it for?
- Ages Up to 36 weeks, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Education and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2024to 20 Jul 2024
- 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 Up to 36 weeks
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- being in the antenatal period
- having their first pregnancy
- not having received breastfeeding counseling before.
Who cannot join
- mothers with previous birth history
- previously educated women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur
Halil ibrahim RN Taşdemir, PhD, +905443356575 ext. 8254, hitasdemir@mehmetakif.edu.tr
About this study
Official title: Effect of Peer Assisted Breastfeeding Education Program (PABEP) on Breastfeeding Self-Efficacy and Breastfeeding Levels: Randomized Controlled Study
It was aimed to evaluate the effect of the Peer Supported Breastfeeding Education Program given during the antenatal period on the breastfeeding knowledge and attitude levels, breastfeeding self-efficacy and breastfeeding levels of postpartum women. For this purpose, the hypotheses created in our study are as follows.
- H1: Breastfeeding knowledge and attitudes of mothers in the PABEP group are significantly higher than those in the control group.
- H1: Breastfeeding proficiency levels of mothers in the PABEP group are significantly higher than those in the control group.
- H1: Breastfeeding success of mothers in the PABEP group is significantly higher than the control group, according to the breastfeeding evaluation results.
- Conditions
- Breast Feeding
- Being tested
- Education, Routine Care
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
PEER ASSISTED BREASTFEEDING EDUCATION PROGRAM
Routine CareOther
Non education program only routine care
| Study group | Role | What they receive |
|---|---|---|
| PABEP group | Experimental | In the research, first of all, breastfeeding training will be given to a nurse mother who has given birth. After this training, the nurse will convey to the mothers the problems she has experienced and coping methods at the end of each training period during the training that the researcher will give to the mothers. Receives: Other: Education |
| Control Group | Active comparator | They will only receive the routine training provided by the application center. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy
It is a scale consisting of 33 items developed by Dennis (1999). The scale prepared as a five-point Likert type; (1) I never trust myself, (2) I don't trust myself very much, (3) I sometimes trust myself, (4) I trust myself most of the time, (5) I always trust myself. As the total score on the scale increases, breastfeeding self-efficacy also increases. The lowest score is 33 and the highest score is 165.
Measured: Research data will be collected during training before birth and at 1 and 4 weeks after birth.
Secondary outcomes (1)
breastfeeding success
The scale consists of six questions and scoring is based on mothers' answers to the questions. The first question is about the baby's starting state of feeding (deep sleep, sleepy, calm-awake, crying). This question is not included in the scoring. The next four questions are about searching and the baby's sucking behavior. Each question is evaluated between 0-3 points and the highest score is 12. The score range in effectively fed babies is 10-12 points. Babies who breastfeed quite successfully when encouraged are given 7-9 points and are considered moderately effective. Babies who do not start feeding upon warning, do not seek nutrition, or breastfeed for short periods are given a score of 0-6. In the last question, mothers record their feelings during feeding (very satisfied, satisfied, not very satisfied, not satisfied). This question is not included in the scoring and is evaluated separately.
Measured: Research data will be collected during training before birth and at 1 and 4 weeks after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start20 Jul 2024 (estimated)
- Primary completion20 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Burdur Mehmet Akif Ersoy University
- Responsible party
- Principal investigator, Halil Ibrahim Tasdemir, Burdur Mehmet Akif Ersoy University
- Investigators
- Halil HI Taşdemir, PhD, Study director, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493474
- Sponsor's protocol ID
- MAKU24-01
- Acronym
- PABEP
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data contains confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peer Assisted Breastfeeding Education Program (PABEP) on Breastfeeding Self-Efficacy and Breastfeeding Levels: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06493474
- Acronym / sponsor ID
- PABEP / MAKU24-01
- Conditions
- Breast Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Burdur Mehmet Akif Ersoy University
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 10 Jul 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.
It was aimed to evaluate the effect of the Peer Supported Breastfeeding Education Program given during the antenatal period on the breastfeeding knowledge and attitude levels, breastfeeding self-efficacy and breastfeeding levels of postpartum women. For this purpose, the hypotheses created in our study are as follows.
- H1: Breastfeeding knowledge and attitudes of mothers in the PABEP group are significantly higher than those in the control group.
- H1: Breastfeeding proficiency levels of mothers in the PABEP group are significantly higher than those in the control group.
- H1: Breastfeeding success of mothers in the PABEP group is significantly higher than the control group, according to the breastfeeding evaluation results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PABEP group | Experimental | Other: EducationIn the research, first of all, breastfeeding training will be given to a nurse mother who has given birth. After this training, the nurse will convey to the mothers the problems she has experienced and coping methods at the end of each training period during the training that the researcher will give to the mothers. |
| Control Group | Active comparator | Other: Routine CareThey will only receive the routine training provided by the application center. |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being in the antenatal period
- having their first pregnancy
- not having received breastfeeding counseling before.
Key exclusion criteria (2 listed)
- mothers with previous birth history
- previously educated women
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 |
|---|---|---|
| EducationPEER ASSISTED BREASTFEEDING EDUCATION PROGRAM | Other | PABEP group |
| Routine CareNon education program only routine care | Other | Control Group |
Primary outcome
Breastfeeding Self-Efficacy
Time frame: Research data will be collected during training before birth and at 1 and 4 weeks after birth.
It is a scale consisting of 33 items developed by Dennis (1999). The scale prepared as a five-point Likert type; (1) I never trust myself, (2) I don't trust myself very much, (3) I sometimes trust myself, (4) I trust myself most of the time, (5) I always trust myself. As the total score on the scale increases, breastfeeding self-efficacy also increases. The lowest score is 33 and the highest score is 165.
1 secondary outcome
breastfeeding success
Time frame: Research data will be collected during training before birth and at 1 and 4 weeks after birth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No. data contains confidentiality
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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.
Halil HI Taşdemir, PhD study director
Burdur Mehmet Akif Ersoy 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 Education and Routine Care in people with Breast Feeding, run by Akdeniz 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 3 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: status not confirmed, as of the sponsor's last update on 10 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halil HI Taşdemir, PhD (+905443356575 ext. 8254, dibrahimtasdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Self-Efficacy (time frame: Research data will be collected during training before birth and at 1 and 4 weeks after birth.). 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 10 Jul 2024.