- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05340842
Evaluation of the Effects of Simulation Based Breastfeeding Training
Evaluation of the Effects of Simulation Based Breastfeeding Training on Women' Breastfeeding Success, Breastfeeding Self Efficacy, Breastfeeding Attitude and Knowledge
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Maltepe
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İstanbul, Maltepe, Turkey, 34844
- Hamide Arslan Tarus
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
32-36 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Simulation training experiment group
In 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. |
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
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No Intervention: Control group
At 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LATCH Breastfeeding Diagnostic and Assessment Scale
Time Frame: 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.
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Attitude and Knowledge Questionnaire
Time Frame: It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
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This form was created by researchers in line with the literature in order to determine the attitudes and knowledge levels of pregnant women towards breastfeeding.In the form, there are a total of 20 statements, 10 statements questioning the level of knowledge about breastfeeding and 10 statements questioning the attitude towards breastfeeding.
Each statement in the form is marked as "True", "Wrong", "I don't know" according to the attitude and knowledge level of the people.
In the evaluation of the form, correct answers were given as "1", "I don't know" or wrong answers were given "0" points.
The lowest score that can be obtained from the entire form is 0 and the highest score is 20.
The Cronbach's alpha value of the attitude and knowledge evaluation form regarding breastfeeding was found to be 0.60 in the antenatal period and 0.75 in the postnatal period.
A high score on the form indicates a high level of positive attitude and knowledge about breastfeeding.
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It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
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Breastfeeding Self-Efficacy Scale-Short Form
Time Frame: It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
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Breastfeeding Self-Efficacy Scale consists of 14 items.
The lowest score that can be obtained from the entire scale is 14 and the highest score is 70.
A high score from the scale indicates a high perception of breastfeeding self-efficacy.
This scale can be applied both in the antenatal and postnatal periods.
The difference of the antenatal form of the scale from the postnatal form is that the phrase "future tense" is used in the scale items.
In the original study of the scale, the Cronbach's alpha value of the antenatal form was 0.87, and the Cronbach's alpha value of the postnatal form was 0.86.
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It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hamide Arslan Tarus, Res. Asist., Marmara University
- Study Director: Gonul Kurt, Assist. Prof, Gulhane Faculty of Nursing
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16214662/050.01.04/30
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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