- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07670247
AI Role-Play Coaching for Breastfeeding Counseling
The Effect of AI-Powered Role-Play Coaching on Breastfeeding Counseling Skills Among Nursing Students: A Randomized Controlled Trial
Breastfeeding counseling is critically important for both maintaining the mother's motivation to breastfeed and ensuring the baby's healthy nutrition. Artificial intelligence (AI)-based role-playing coaching is an innovative teaching approach that allows students to experience the counseling process through digital scenarios, identify and correct their mistakes in a risk-free environment, and receive instant feedback based on their performance. In this context, this study aims to examine the effect of AI-assisted role-playing coaching on breastfeeding counseling skills in nursing students using a randomized controlled experimental design.
The study was conducted in the Nursing Laboratory of a university's Nursing Department between March 2026 and July 2026. Participants were divided into three groups: Peer role-playing group, Classical theoretical training (control) group, and AI-assisted role-playing group. Data were collected using a personal information form, the Self-Efficacy Scale for Supporting Breastfeeding Mothers, and the Breastfeeding Counseling Role-Playing Assessment Rubric. The findings show that the peer role-playing group has a higher ability to establish open, supportive, and empathetic communication with the mother, while the AI-assisted role-playing group has a higher ability to collect, evaluate, and provide feedback on data. Furthermore, breastfeeding self-efficacy was found to be higher in the AI-assisted role-playing group.
The data obtained have the potential to generate evidence for the use of next-generation learning technologies in nursing education and contribute to training graduate nurses ready for clinical practice. It will also provide a scientific basis for developing training strategies aimed at improving the quality of breastfeeding support services.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bilecik, Turkey (Türkiye), 11230
- Bilecik Şeyh Edebali University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Proficient in computer use
- Fluent in Turkish
- Willing to participate in the study
- A third-year nursing student currently taking the "Obstetrics and Gynecology Nursing" course
Exclusion Criteria:
- Those who do not agree to participate in the study
- Those who do not have sufficient knowledge of Turkish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI-powered role-playing group
The students in this group worked with a Turkish chatbot based on a large language model (such as ChatGPT).
The chatbot was positioned as a virtual patient assuming the role of "mother" in the training scenario.
Thus, students conducted the counseling session by engaging in a natural dialogue with an AI.
By generating context-sensitive responses and providing appropriate reactions to the counseling messages the students sent, the AI enabled students to practice their communication and counseling skills in a realistic setting.
|
The students in this group worked with a Turkish chatbot based on a large language model (such as ChatGPT).
The chatbot was positioned as a virtual patient assuming the role of "mother" in the training scenario.
Thus, students conducted the counseling session by engaging in a natural dialogue with an AI.
By generating context-sensitive responses and providing appropriate reactions to the counseling messages the students sent, the AI enabled students to practice their communication and counseling skills in a realistic setting.
|
|
Experimental: Peer role-play group
In this group, students formed small pairs or trios to act out the scenarios.
By taking turns switching roles, they played the role of "mother" one time and the role of "counselor" the next.
This allowed them to both practice their counseling skills and view the counseling process from the "mother's" perspective.
|
In this group, students formed small pairs or trios to act out the scenarios.
By taking turns switching roles, they played the role of "mother" one time and the role of "counselor" the next.
This allowed them to both practice their counseling skills and view the counseling process from the "mother's" perspective.
|
|
No Intervention: Traditional theoretical training (control) group
In this group, students learned about the same topics through brief instructional presentations, case studies, and question-and-answer sessions.
However, this training did not include practical role-playing exercises or one-on-one coaching.
Consequently, a traditional training method focused primarily on knowledge transfer was applied to this group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy Scale for Supporting Breastfeeding Mothers
Time Frame: half an hour after the intervention
|
Developed by Dennis (2003) for use with breastfeeding mothers, the scale was revised by Blackman et al. and validated in Turkish by Bayri Bingöl et al. (2025).
The scale is a 4-point Likert-type measure consisting of 37 items with response options of "Very easy," "Easy," "Difficult," and "Very difficult."
Higher scores on the scale indicate higher self-efficacy in breastfeeding counseling.
In the Turkish validity and reliability study of the scale, the total Cronbach's alpha value was 0.97.
Permission to use the scale in our study was obtained from Assoc.
Prof. Dr. Fadime BAYRI BİNGÖL.
|
half an hour after the intervention
|
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Breastfeeding Counseling Role-Play Assessment Rubric
Time Frame: half an hour after the intervention
|
This assessment tool is a structured rubric developed to measure nursing students' breastfeeding counseling skills. The rubric aims to comprehensively evaluate students' cognitive, affective, and psychomotor competencies during role-play exercises based on a mastitis case scenario. The criteria cover seven key dimensions: communication and empathy, data collection and clinical assessment, educational role, problem-solving and guidance, professional attitude, time management, and reflection. Each dimension is scored using three-level behavioral indicators (high=3, moderate=2, low=1) that qualitatively describe the student's performance. The total score obtained in the rubric reflects the student's overall competence regarding the breastfeeding counseling process (High level: 18-21, moderate level: 13-17, low level: ≤12). In determining the criteria, clinical skill and communication-based assessment tools found in the nursing education literature were taken into consideration. The rubri |
half an hour after the intervention
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Breastfeeding-AI-2026
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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