Evaluation of the Effects of Simulation Based Breastfeeding Training
1 other identifier
interventional
128
1 country
1
Brief Summary
This study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and knowledge of breastfeeding.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedDecember 9, 2024
December 1, 2024
9 months
April 4, 2022
December 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LATCH Breastfeeding Diagnostic and Assessment Scale
LATCH consists of the combination of the first letters of the English equivalent of the five criteria defined above. Each item is evaluated between 0-2 points. The lowest score that can be obtained from the entire scale is 0 and the highest score is 10. The scale has no breakpoints. The low score on the scale indicates the need for active intervention, support and follow-up after discharge in breastfeeding. The higher the LATCH Breastfeeding Diagnosis and Evaluation Scale score, the higher the success of breastfeeding. Cronbach's alpha value was found to be 0.95 in the study in which the Turkish validity and reliability of the scale was carried out.
The scale was filled twice, with an average of two hours, in the first 24 hours after delivery, when the mother was free of pain and felt well.
Secondary Outcomes (2)
Breastfeeding Attitude and Knowledge Questionnaire
It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
Breastfeeding Self-Efficacy Scale-Short Form
It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
Study Arms (2)
Simulation training experiment group
EXPERIMENTALIn this training, the researcher firstly explained breastfeeding by wearing the Lactation Simulation Model on himself and showing it practically on himself. Afterwards, the model was dressed on the pregnant woman and the pregnant woman was given one-on-one breastfeeding practice. In this process, all questions of the pregnant woman were answered by the researcher.
Control group
NO INTERVENTIONAt this stage, the standard video screening prepared for breastfeeding education within the scope of the hospital protocol was shown to the pregnant woman by the researcher with a tablet.
Interventions
In this study, applied breastfeeding training with Lactation Simulation Model was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period
Eligibility Criteria
You may qualify if:
- between gestational weeks Primigravida No systemic/chronic disease Planning to breastfeed Who has not received a planned breastfeeding training before Can speak and understand Turkish Pregnant women who agreed to participate in the study were included.
You may not qualify if:
- Breastfeeding contraindications Having a high-risk pregnancy Preterm delivery (before 37 weeks of gestation) Having a health condition that prevents breastfeeding in the newborn after birth Having mental disability and serious mental disorder Women with multiple pregnancies were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hamide Arslan Tarus
Istanbul, Maltepe, 34844, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hamide Arslan Tarus, Res. Asist.
Marmara University
- STUDY DIRECTOR
Gonul Kurt, Assist. Prof
Gulhane Faculty of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant, Principal Investigator
Study Record Dates
First Submitted
April 4, 2022
First Posted
April 22, 2022
Study Start
June 1, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
December 9, 2024
Record last verified: 2024-12