- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06081374
The Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems
October 11, 2023 updated by: seda karaçay yıkar, Cukurova University
Determining the Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems: A Randomized Controlled Study
In the literature, there are studies conducted to determine the effect of simulation-based and different training techniques models given in the prenatal period on postpartum breastfeeding self-efficacy.
However, no study was found that evaluated the effects of simulation-based and different training techniques given in the prenatal period on breastfeeding self-efficacy and breastfeeding problems.
Therefore, this study was planned to determine the effect of simulation-based breastfeeding education on breastfeeding self-efficacy and breastfeeding problems in the prenatal period.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
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
-
-
Sarıcam
-
Adana, Sarıcam, Turkey, 00130
- Seda Karaçay Yıkar
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Pregnants between32nd-36th gestational weeks,
- Primigravida,
- Planning to breastfeed,
- Can speak and understand Turkish,
- Pregnant women who agreed to participate in the study were included.
Exclusion Criteria:
Breastfeeding contraindications,
- Having a risky pregnancy, Having received a planned breastfeeding training before,
- Premature birth (before 37th weeks of gestation),
- Having a systemic/chronic disease
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: simulation intervention
simulation will be implemented.
|
Breastfeeding education is planned by dressing pregnant women with simulation models.
Other Names:
|
|
Active Comparator: education implication
education will be implemented.
|
Breastfeeding education is planned by dressing pregnant women with simulation models.
Other Names:
|
|
No Intervention: control group
no intervention will be made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
simulation affect on breastfeeding self-efficacy
Time Frame: postpartum 7th week
|
It is planned to increase women's breastfeeding self-efficacy through training Breastfeeding Self-efficacy scale points are supposed to be between 14-70 points.
Getting higher points shows better breastfeeding self-efficacy.
|
postpartum 7th week
|
|
simulation affect on breastfeeding problems
Time Frame: postpartum 7th week
|
It is planned to prevent possible breast problems with the training given to women.
It is supposed to get points from 18 to 90 related to Breastfeeding Experience Scale.Getting lower points is more preferable than higher points.
Getting points near to 90 shows increased problems related to breastfeeding.
|
postpartum 7th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
November 1, 2023
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
November 1, 2024
Study Registration Dates
First Submitted
July 10, 2023
First Submitted That Met QC Criteria
October 11, 2023
First Posted (Actual)
October 13, 2023
Study Record Updates
Last Update Posted (Actual)
October 13, 2023
Last Update Submitted That Met QC Criteria
October 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123 (Giresun University Scientific Research Project)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
data will be kept in confident
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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