Artificial Intelligence (AI)NCT07670247
AI Role-Play Coaching for Breastfeeding Counseling
A study testing AI-powered role-playing intervention and Peer role play intervention in people with Artificial Intelligence (AI) and Breastfeeding Self-Efficacy, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artificial Intelligence (AI), Breastfeeding Self-Efficacy, Breastfeeding
- What is being tested?
- AI-powered role-playing intervention and Peer role play intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Those who do not agree to participate in the study
- Those who do not have sufficient knowledge of Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bilecik Şeyh Edebali University
Bilecik, 11230
About this study
Official title: 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.
- Being tested
- AI-powered role-playing intervention, Peer role play intervention
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-powered role-playing interventionOther
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.
Peer role play interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-powered role-playing group | Experimental | 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. Receives: Other: AI-powered role-playing intervention |
| Peer role-play group | Experimental | 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. Receives: Other: Peer role play intervention |
| Traditional theoretical training (control) group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy Scale for Supporting Breastfeeding Mothers
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.
Measured: half an hour after the intervention
Breastfeeding Counseling Role-Play Assessment Rubric
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
Measured: half an hour 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 posted26 Jun 2026
- Study start9 Mar 2026
- Primary completion4 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial Intelligence (AI)Studies 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 were divided into 3 groups (AI-assisted role-playing, peer role-playing, and classical theoretical training). Random assignment was performed by an external statistician, who had no prior contact with participants who met the inclusion criteria and agreed to participate in the study, using the 'Research Randomizer' website (www.randomizer.org). This tool generated a total of 80 different numbers and randomly assigned participants to the 3 groups. These numbers were then placed in a box, and students were assigned to a group according to the number they chose.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahime Aksoy, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670247
- Sponsor's protocol ID
- Breastfeeding-AI-2026
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of AI-Powered Role-Play Coaching on Breastfeeding Counseling Skills Among Nursing Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07670247
- Acronym / sponsor ID
- Breastfeeding-AI-2026
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 26 Jun 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were divided into 3 groups (AI-assisted role-playing, peer role-playing, and classical theoretical training). Random assignment was performed by an external statistician, who had no prior contact with participants who met the inclusion criteria and agreed to participate in the study, using the 'Research Randomizer' website (www.randomizer.org). This tool generated a total of 80 different numbers and randomly assigned participants to the 3 groups. These numbers were then placed in a box, and students were assigned to a group according to the number they chose.
| Arm | Type | Receives |
|---|---|---|
| AI-powered role-playing group | Experimental | Other: AI-powered role-playing interventionThe 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. |
| Peer role-play group | Experimental | Other: Peer role play interventionIn 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. |
| Traditional theoretical training (control) group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Those who do not agree to participate in the study
- Those who do not have sufficient knowledge of Turkish
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 |
|---|---|---|
| AI-powered role-playing interventionThe 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. | Other | AI-powered role-playing group |
| Peer role play interventionIn 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. | Other | Peer role-play group |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Artificial Intelligence (AI)
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Recruiting
AI-assisted Home-based Intervention for ADHD Children
ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
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 AI-powered role-playing intervention and Peer role play intervention in people with Artificial Intelligence (AI) and Breastfeeding Self-Efficacy, run by Bilecik Seyh Edebali Universitesi 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 4 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: finished, as of the sponsor's last update on 26 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-Efficacy Scale for Supporting Breastfeeding Mothers (time frame: half an hour after the intervention). The study lists 2 primary outcomes in all. 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 26 Jun 2026.