- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07332208
Evaluation of Breastfeeding Education Using the Role-Play Technique
Evaluation of Breastfeeding Education Delivered Using the Role-Play Technique Among Adolescent Pregnant Women: A Randomized Controlled Study
Adolescence is defined as a period of rapid biological and physical development, as well as sexual and psychosocial maturation, during which the individual gains independence and social productivity. This developmental period largely corresponds to the age range of 10 to 19 years, consistent with the WHO (World Health Organization) definition of adolescence. Adolescent pregnancy is considered a public health issue by the WHO due to its biopsychosocial effects on maternal and child health. Adolescents often seek antenatal care late due to a lack of information, limited access to healthcare, social pressure, and fear of stigma. There are many increased risks for both mother and newborn during adolescent pregnancy. The low educational level of adolescent pregnant women also negatively affects access to necessary healthcare services. Breastfeeding is the most appropriate way to provide breast milk to the baby for healthy development. It is the healthiest, easiest, most natural, and most economical method of feeding the baby. The World Health Organization (WHO) recommends initiating breastfeeding within the first hour after birth . Providing planned education to protect and improve the health of individuals, families, and communities, and to ensure they acquire correct health behaviors, is among the fundamental duties of nurses, who are in the most contact with healthy/sick individuals in the community.
Role-playing is among the educational methods used to increase awareness in nursing. Role-playing is used in education as a skill-oriented teaching method that enables social communication skills, active listening, empathy for emotions, and seeing excerpts from real life in teaching knowledge and skills. Especially in educational groups with low education levels, the effectiveness of education can be increased by using the role-playing technique.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Şanlıurfa
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Sanliurfa, Şanlıurfa, Turkey (Türkiye), 6363
- Şanlıurfa Eyyübiye Ilçe Sağlık Müdürlüğü
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescent pregnant women
- Not having received any formal breastfeeding education previously
Exclusion Criteria:
- Pregnant women outside the adolescent age range
- Having previously received breastfeeding education
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Adolescent Pregnant Women Receiving Standard Breastfeeding Education
Participants in this cohort receive standard breastfeeding education as part of routine prenatal care.
The education is delivered using conventional instructional methods and does not include the role-play technique.
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Participants receive standard breastfeeding education delivered according to routine prenatal care practices using conventional instructional methods.
|
|
Experimental: Adolescent Pregnant Women Receiving Role-Play-Based Breastfeeding Education
Participants in this cohort receive breastfeeding education delivered using the role-play technique as part of prenatal care.
The intervention includes interactive role-play scenarios designed to improve breastfeeding knowledge, skills, and self-efficacy.
|
Participants receive breastfeeding education delivered using role-play techniques as part of routine prenatal care.
The intervention includes interactive role-play scenarios designed to improve breastfeeding knowledge, practical skills, and breastfeeding self-efficacy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Knowledge Level
Time Frame: Baseline (pre-intervention) and immediately after the intervention
|
Change in breastfeeding knowledge level assessed using a structured questionnaire developed to evaluate breastfeeding-related knowledge.
|
Baseline (pre-intervention) and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Self-Efficacy Level
Time Frame: Baseline (pre-intervention) and immediately after the intervention
|
Change in breastfeeding self-efficacy level assessed using the Prenatal Breastfeeding Self-Efficacy Scale (PBSES).
The scale evaluates mothers' confidence in their ability to breastfeed.
|
Baseline (pre-intervention) and immediately after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/019 Ethics Committee Appr
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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