Back to resultsThe Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems
Primary Purpose
Postpartum Complication, Caesarean Section;Stillbirth
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
simulation implication
Sponsored by
About this trial
This is an interventional supportive care trial for Postpartum Complication
Eligibility Criteria
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
Sites / Locations
- Seda Karaçay Yıkar
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
simulation intervention
education implication
control group
Arm Description
simulation will be implemented.
education will be implemented.
no intervention will be made.
Outcomes
Primary Outcome Measures
simulation affect on breastfeeding self-efficacy
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.
simulation affect on breastfeeding problems
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06081374
Brief Title
The Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems
Official Title
Determining the Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Complication, Caesarean Section;Stillbirth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
simulation intervention
Arm Type
Experimental
Arm Description
simulation will be implemented.
Arm Title
education implication
Arm Type
Active Comparator
Arm Description
education will be implemented.
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intervention will be made.
Intervention Type
Device
Intervention Name(s)
simulation implication
Other Intervention Name(s)
nursing education
Intervention Description
Breastfeeding education is planned by dressing pregnant women with simulation models.
Primary Outcome Measure Information:
Title
simulation affect on breastfeeding self-efficacy
Description
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.
Time Frame
postpartum 7th week
Title
simulation affect on breastfeeding problems
Description
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.
Time Frame
postpartum 7th week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women will be included
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Seda Karaçay Yıkar
City
Adana
State/Province
Sarıcam
ZIP/Postal Code
00130
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
data will be kept in confident
Learn more about this trial
The Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems
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