- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515862
Hospital-Based Breastfeeding Training İn The Early Postpartum Period (BF)
A Randomızed Controlled Study On Analysıs Of Effect Of Hospıtal Based Breast-Feedıng Group Traınıng Provıded In Early Postpartum Perıod About Breast-Feedıng Self-Effıcacy And Breast-Feedıng Status Of Maternals
H1: "Breastfeeding Self-Efficacy Status" is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group receiving routine care.
H2: The level of knowledge obtained according to the "Pre-test Post-test Question Form" in mothers who received postnatal hospital-based breastfeeding group training is higher than before the education.
H3: The status of starting and successfully continuing breastfeeding is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group who received routine care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Can be contacted,
- had a single birth,
- Those who are 18 years old or older,
- Residing in Izmir,
- able to use phone
- were determined to be mothers with no health problems in the mother and the baby
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: intervention
Intervention group: Mothers in the intervention group were included in the breastfeeding training program with the group training method.
The training program was developed by the researchers, and the content of the program was evaluated with the expert opinion of academicians, obstetricians, nurses and breastfeeding counselor midwives working on breastfeeding.
|
The importance of breastfeeding Benefits of breastfeeding for mother and baby Structure of the breast and milk production Breastfeeding techniques and positions Breastfeeding problems and breast care
|
NO_INTERVENTION: control
Control Group:Routine obstetric care and treatment procedures were applied to the mothers in the control group.
In the hospital where the study was conducted, all mothers are routinely evaluated for breastfeeding by an infant nurse.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding Self-Efficacy Scale
Time Frame: twelve weeks
|
This scale was developed by Cindy-Lee Dennis to measure breastfeeding competence and consists of 2 subscales and 33 items.
The Turkish validity and reliability of the breastfeeding proficiency scale was made by Ekşioğlu and Çeber (2011).
Breastfeeding self-efficacy increases as the total score increases in the 5-point Likert-type scale with a Cronbach Alpha coefficient of 0.91.
The lowest score is 33, the highest score is 165.
|
twelve weeks
|
Pre-Test Post-Test Information Form
Time Frame: twelve weeks
|
It is a question form consisting of 25 questions in order to evaluate the knowledge about breastfeeding and breast milk before and after the training.
The first application was done before the training and the second application was carried out in the 12th week.
|
twelve weeks
|
Breastfeeding levels of mothers
Time Frame: four weeks, twelve weeks
|
The exclusive breastfeeding levels of their babies in the fourth and twelfth weeks of the mothers who received and did not receive education were evaluated.
|
four weeks, twelve weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.
- Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
- Yilmaz M, Aykut M. The effect of breastfeeding training on exclusive breastfeeding: a randomized controlled trial. J Matern Fetal Neonatal Med. 2021 Mar;34(6):925-932. doi: 10.1080/14767058.2019.1622672. Epub 2019 Jul 25.
- Eksioglu AB, Ceber E. Translation and validation of the Breast-feeding Self-efficacy Scale into Turkish. Midwifery. 2011 Dec;27(6):e246-53. doi: 10.1016/j.midw.2010.10.009. Epub 2010 Dec 8.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Yesim Yesil
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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