Nursing EducationNCT07332208
Evaluation of Breastfeeding Education Using the Role-Play Technique
A study testing Standard Breastfeeding Education and Role-Play-Based Breastfeeding Education in people with Nursing Education and Breastfeeding Education, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 20 years, women only
- Conditions the study is for
- Nursing Education, Breastfeeding Education, Adolescent Pregnancy
- What is being tested?
- Standard Breastfeeding Education and Role-Play-Based Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent pregnant women
- Not having received any formal breastfeeding education previously
Who cannot join
- Pregnant women outside the adolescent age range
- Having previously received breastfeeding education
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şanlıurfa Eyyübiye Ilçe Sağlık Müdürlüğü
Sanliurfa, Şanlıurfa, 6363
About this study
Official title: 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.
- Being tested
- Standard Breastfeeding Education, Role-Play-Based Breastfeeding Education
- Keywords
- Breastfeeding, Adolescent Pregnancy, Breastfeeding Education, Role-play education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Breastfeeding EducationOther
Participants receive standard breastfeeding education delivered according to routine prenatal care practices using conventional instructional methods.
Role-Play-Based Breastfeeding EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Role-Play-Based Breastfeeding Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Knowledge Level
Change in breastfeeding knowledge level assessed using a structured questionnaire developed to evaluate breastfeeding-related knowledge.
Measured: Baseline (pre-intervention) and immediately after the intervention
Secondary outcomes (1)
Breastfeeding Self-Efficacy Level
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.
Measured: Baseline (pre-intervention) and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start29 Apr 2025
- Primary completion29 Apr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Ciftçiler, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332208
- Sponsor's protocol ID
- 2025/019 Ethics Committee Appr
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and institutional restrictions and to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Breastfeeding Education Delivered Using the Role-Play Technique Among Adolescent Pregnant Women: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07332208
- Acronym / sponsor ID
- 2025/019 Ethics Committee Appr
- Keywords
- Breastfeeding, Adolescent Pregnancy, Breastfeeding Education, Role-play education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 29 Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adolescent Pregnant Women Receiving Standard Breastfeeding Education | Active comparator | Other: Standard Breastfeeding EducationParticipants 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. |
| Adolescent Pregnant Women Receiving Role-Play-Based Breastfeeding Education | Experimental | Behavioral: Role-Play-Based Breastfeeding EducationParticipants 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. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescent pregnant women
- Not having received any formal breastfeeding education previously
Key exclusion criteria (2 listed)
- Pregnant women outside the adolescent age range
- Having previously received breastfeeding education
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Breastfeeding EducationParticipants receive standard breastfeeding education delivered according to routine prenatal care practices using conventional instructional methods. | Other | Adolescent Pregnant Women Receiving Standard Breastfeeding Education |
| Role-Play-Based Breastfeeding EducationParticipants 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. | Behavioural | Adolescent Pregnant Women Receiving Role-Play-Based Breastfeeding Education |
Primary outcome
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.
1 secondary outcome
Breastfeeding Self-Efficacy Level
Time frame: Baseline (pre-intervention) and immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and institutional restrictions and to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Breastfeeding Education and Role-Play-Based Breastfeeding Education in people with Nursing Education and Breastfeeding Education, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Knowledge Level (time frame: Baseline (pre-intervention) and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.