- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06493474
Peer Assisted Breastfeeding Education Program (PABEP)
July 6, 2024 updated by: Halil Ibrahim Tasdemir, Akdeniz University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Halil HI Taşdemir, PhD
- Phone Number: 8254 +905443356575
- Email: dibrahimtasdemir@gmail.com
Study Contact Backup
- Name: Deniz D Taşdemir, RN
- Phone Number: +905378257687
- Email: denizdtasdemir@gmail.com
Study Locations
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-
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Burdur, Turkey
- Burdur Mehmet Akif Ersoy University
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Contact:
- Halil ibrahim RN Taşdemir, PhD
- Phone Number: 8254 +905443356575
- Email: hitasdemir@mehmetakif.edu.tr
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- being in the antenatal period
- having their first pregnancy
- not having received breastfeeding counseling before.
Exclusion Criteria:
- mothers with previous birth history
- previously educated women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PABEP group
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.
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PEER ASSISTED BREASTFEEDING EDUCATION PROGRAM
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|
Active Comparator: Control Group
They will only receive the routine training provided by the application center.
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Non education program only routine care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Research data will be collected during training before birth and at 1 and 4 weeks after birth.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
breastfeeding success
Time Frame: Research data will be collected during training before birth and at 1 and 4 weeks after birth.
|
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.
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Research data will be collected during training before birth and at 1 and 4 weeks after birth.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Halil HI Taşdemir, PhD, Burdur Mehmet Akif Ersoy University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 20, 2024
Primary Completion (Estimated)
July 20, 2024
Study Completion (Estimated)
July 20, 2024
Study Registration Dates
First Submitted
June 26, 2024
First Submitted That Met QC Criteria
July 6, 2024
First Posted (Actual)
July 10, 2024
Study Record Updates
Last Update Posted (Actual)
July 10, 2024
Last Update Submitted That Met QC Criteria
July 6, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- MAKU24-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
data contains confidentiality
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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