- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05624047
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
Status
Completed
Conditions
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
-
-
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Bitlis, Turkey
- Bitlis Hüsrevpaşa Family Center
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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.
Sponsor
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
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