The Effect of Breastfeeding Education Via Hybrid Simulation Method in the Antenatal Period on Postpartum Breastfeeding

August 12, 2023 updated by: Sultan OZKAN SAT, Bitlis Eren University

The Effect of Breastfeeding Education Via Hybrid Simulation Method in the Antenatal Period on Postpartum Breastfeeding: A Randomized Controlled Trial

This study aimed to determine the effect of breastfeeding education given to pregnant women by a hybrid simulation method in the antenatal period on postpartum breastfeeding. This study will be carried out in a family health center in Turkey. Breastfeeding education will be given to pregnant women using a hybrid simulation method consisting of a wearable breast model and the standard patient in the intervention group. Women in the control group will receive only routine breastfeeding education.

Study Overview

Detailed Description

The research will be conducted as a randomized controlled trial. The stratified block randomization methods will be used to assign women to the intervention and control groups. The personal information form and Breastfeeding Self-Efficacy Scale Short Form (Antenatal) will be implemented to all women before the intervention. Breastfeeding education will be given to pregnant women using a hybrid simulation method consisting of a wearable breast model and the standard patient to support women in breastfeeding and to ensure the continuity of breastfeeding in the postpartum period. Breastfeeding education will be given to women in the 32-36 weeks of pregnancy in the antenatal period. The control group will be received the routine antenatal breastfeeding education given to all women by healthcare personnel as part of the family health center procedures. The Breastfeeding Self-Efficacy Scale Short Form (Postnatal) and the LATCH Breastfeeding Assessment Tool will be administered to women in both the experimental and control groups within the postpartum fifth days and at sixth week postpartum.

Study Type

Interventional

Enrollment (Actual)

66

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

      • Bitlis, Turkey
        • Bitlis Hüsrevpaşa Family Center

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:

  • being between 32-36 weeks of pregnancy
  • being primipara or multipara
  • being at least literate
  • being planning to breastfeed
  • agreeing to participate in the study

Exclusion Criteria:

  • having a physical or mental health problem that would prevent breastfeeding
  • preterm labor (before 37 weeks)
  • either mother or baby having a health problem after birth
  • being with multiple pregnancy
  • being with high-risk pregnancy

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: Experimental Group
Breastfeeding education using the hybrid simulation method
In addition to the verbal breastfeeding training given to the pregnant women assigned to the experimental group, breastfeeding training will be given using the hybrid simulation method consisting of a wearable breast model and standard patient practice.
Women in this group will receive oral breastfeeding training, which is routinely given in the pregnant education class and consists of one session.
Other: Control Group
Routine verbal breastfeeding education
Women in this group will receive oral breastfeeding training, which is routinely given in the pregnant education class and consists of one session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Breastfeeding Self-Efficacy Scale-Short Form (Antenatal)
Time Frame: Baseline: Between 32 and 36 weeks of pregnancy
The scale consists of 14 questions and is a five-point Likert type. The lowest score of 14 points and the highest of 70 points are obtained from the scale. The higher the score indicates a higher self-efficacy perception.
Baseline: Between 32 and 36 weeks of pregnancy
The Breastfeeding Self-Efficacy Scale-Short Form (Postnatal)
Time Frame: Postpartum on the fifth day
The scale consists of 14 questions and is a five-point Likert type. The lowest score of 14 points and the highest of 70 points are obtained from the scale. The higher the score indicates a higher self-efficacy perception.
Postpartum on the fifth day
The Breastfeeding Self-Efficacy Scale-Short Form (Postnatal)
Time Frame: Postpartum 6th week
The scale consists of 14 questions and is a five-point Likert type. The lowest score of 14 points and the highest of 70 points are obtained from the scale. The higher the score indicates a higher self-efficacy perception.
Postpartum 6th week
LATCH Breastfeeding Assesment Tool
Time Frame: Postpartum on the fifth day
The LATCH Breastfeeding Assesment Tool was developed to objectively evaluate breastfeeding success. LATCH consists of five evaluation criteria. Each criterion 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 higher score indicates a higher breastfeeding. success.
Postpartum on the fifth day
LATCH Breastfeeding Assesment Tool
Time Frame: Postpartum 6th week
The LATCH Breastfeeding Assesment Tool was developed to objectively evaluate breastfeeding success. LATCH consists of five evaluation criteria. Each criterion 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 higher score indicates a higher breastfeeding. success.
Postpartum 6th week

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sultan Özkan Şat, Dr, Bitlis Eren 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 (Actual)

December 1, 2022

Primary Completion (Actual)

August 12, 2023

Study Completion (Actual)

August 12, 2023

Study Registration Dates

First Submitted

November 13, 2022

First Submitted That Met QC Criteria

November 13, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SOZKANSAT

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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