- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06918574
Breastfeeding Roadmap in Primiparous Women
The Effect of Breastfeeding Roadmap on Breastfeeding Self-Efficacy Perception and Breastfeeding Success in Primiparous Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research was planned as a randomized controlled experimental study. Mothers who meet the inclusion criteria and agree to participate in the study will be assigned to the intervention and control groups according to the randomization list.
A total of 74 primiparous mothers who gave birth, 37 in the intervention group and 37 in the control group, will be included in the study.
In addition to the routine breastfeeding education given by the clinic's education nurse, the mothers in the intervention group will also receive a "Breastfeeding Roadmap" education poster prepared by the researchers, which will be hung on the wall of their rooms. The researcher will introduce the Breastfeeding Roadmap to the mothers and provide information on breastfeeding. Routine hospital breastfeeding education will receive to mothers in the control group after childbirth.
Data Collection Pre-Test; Introductory Information Form, Breastfeeding Self-Efficacy Scale Short-Form, LATCH Breastfeeding Assessment Tool will be collected within the first hour after birth (before Breastfeeding Roadmap breastfeeding education and hospital routine breastfeeding education were implemented) Post-test; Breastfeeding Self-Efficacy Scale Short-Form, LATCH Breastfeeding Assessment Tool will be collected at least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours).
At the end of the study, the results of the mothers in the experimental and control groups will be evaluated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Konya, Turkey
- Necmettin Erbakan University Faculty of Medicine Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteer to participate in the study,
- Primiparous,
- Giving birth at 37 weeks of gestation or later,
- No condition preventing breastfeeding,
- No condition preventing breastfeeding in the baby,
- At least primary school graduate,
- Mothers aged 18 and over
Exclusion Criteria:
- Those who have given birth to multiple pregnancies,
- Those who received general anesthesia for Caesarean section,
- Those who have any chronic disease, diagnosed mental or psychiatric illness history,
- Those who have a history of preeclampsia, eclampsia and gestational diabetes,
- Those whose babies are in intensive care after birth
Study Plan
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 |
|---|---|
|
No Intervention: Control group
The control group of the study will receive routine breastfeeding education provided by the clinic's education nurse.
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|
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Experimental: Intervention group
In addition to the routine breastfeeding education given by the clinic's education nurse, the mothers in the intervention group will also receive a "Breastfeeding Roadmap" education poster prepared by the researchers, which will be hung on the wall of their rooms.
The researcher will introduce the Breastfeeding Roadmap to the mothers and provide information on breastfeeding.
|
Information about the "Breastfeeding Roadmap" prepared by the researchers will be explained to the mothers in the intervention group and hung in poster rooms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic characteristics
Time Frame: Within the first hour after the mother's birth.
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Comparison of sociodemographic characteristics of women before the intervention with the questionnaire
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Within the first hour after the mother's birth.
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Breastfeeding Self-Efficacy Short Form Scale
Time Frame: Within the first hour after the mother's birth.
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Mothers whose pre-test data are collected will be assigned to intervention and control groups (Pre-test). The scale consists of 14 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy. |
Within the first hour after the mother's birth.
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LATCH Breastfeeding Assessment Tool
Time Frame: Within the first hour after the mother's birth
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Mothers whose pre-test data are collected will be assigned to intervention and control groups (pre-test). The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10. The higher the score obtained from the scale, the higher the breastfeeding success. |
Within the first hour after the mother's birth
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Breastfeeding Self-Efficacy Short Form Scale
Time Frame: At least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours)
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Post-test data will be collected before mothers are discharged from the hospital (Post-test). The scale consists of 14 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy. |
At least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours)
|
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LATCH Breastfeeding Assessment Tool
Time Frame: At least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours)
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Post-test data will be collected before mothers are discharged from the hospital (Post-test). The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10. The higher the score obtained from the scale, the higher the breastfeeding success. |
At least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ebru Bekmezci PhD, Selcuk University
- Principal Investigator: Hediye Karakoç PhD, KTO Karatay University
- Principal Investigator: Halime Esra Meram PhD, Selcuk University
- Principal Investigator: Jule Eriç Horasanlı Doctor, ASSOCIATE PROFESSOR, Necmettin Erbakan University Medical Faculty Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024/048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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