NCT07332208

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Apr 2025Dec 2026

Study Start

First participant enrolled

April 29, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

December 24, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

BreastfeedingAdolescent PregnancyBreastfeeding EducationRole-play education

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Knowledge Level

    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 Outcomes (1)

  • Breastfeeding Self-Efficacy Level

    Baseline (pre-intervention) and immediately after the intervention

Study Arms (2)

Adolescent Pregnant Women Receiving Standard Breastfeeding Education

ACTIVE COMPARATOR

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.

Other: Standard Breastfeeding Education

Adolescent Pregnant Women Receiving Role-Play-Based Breastfeeding Education

EXPERIMENTAL

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.

Behavioral: Role-Play-Based Breastfeeding Education

Interventions

Participants receive standard breastfeeding education delivered according to routine prenatal care practices using conventional instructional methods.

Adolescent Pregnant Women Receiving Standard Breastfeeding Education

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.

Adolescent Pregnant Women Receiving Role-Play-Based Breastfeeding Education

Eligibility Criteria

Age16 Years - 20 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent pregnant women
  • Not having received any formal breastfeeding education previously

You may not qualify if:

  • Pregnant women outside the adolescent age range
  • Having previously received breastfeeding education

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şanlıurfa Eyyübiye Ilçe Sağlık Müdürlüğü

Sanliurfa, Şanlıurfa, 6363, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to either an intervention group receiving role-play-based breastfeeding education or a control group receiving routine care. Outcomes are compared between parallel groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Researcher

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 12, 2026

Study Start

April 29, 2025

Primary Completion

April 29, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical and institutional restrictions and to protect participant confidentiality.

Locations