Evaluation of the Effects of Simulation Based Breastfeeding Training

December 4, 2024 updated by: Hamide Aslan, Marmara University

Evaluation of the Effects of Simulation Based Breastfeeding Training on Women' Breastfeeding Success, Breastfeeding Self Efficacy, Breastfeeding Attitude and Knowledge

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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. The research was carried out with the participation of two groups. In this context, applied breastfeeding training with LSM was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period, and standard training-video training under the hospital protocol (video training group, n = 64) was provided to pregnant women in the control group. Then, breastfeeding success, breastfeeding self efficacy, attitude and knowledge levels regarding breastfeeding were evaluated in the postnatal period. The data of the research were collected through Participant Description Questionnaire, LATCH Assessment Tool, Breastfeeding Attitude and Knowledge Questionnaire, Breastfeeding Self efficacy Scale and Postnatal Period Follow-up Questionnaire. In addition, LSM was employed in the implementation for the simulation training group. Research data were analyzed by using SPSS 23.0 statistics program.

Study Type

Interventional

Enrollment (Actual)

128

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 Locations

    • Maltepe
      • İstanbul, Maltepe, Turkey, 34844
        • Hamide Arslan Tarus

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

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

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

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

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.
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 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.
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.
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
Time Frame: It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
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.
It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hamide Arslan Tarus, Res. Asist., Marmara University
  • Study Director: Gonul Kurt, Assist. Prof, Gulhane Faculty of Nursing

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 (Actual)

June 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 16, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

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

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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