Infertility CounselingAI-OSCE-InfertNCT07404020
AI-Powered OSCE Coaching in Improving Infertility Counseling Skills in Nursing Students
A study testing AI-Powered OSCE Coaching in people with Infertility Counseling and Communication Skills, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled experimental study aims to evaluate the effectiveness of a generative artificial intelligence-based "OSCE Coach" in improving infertility counseling communication and empathy skills among nursing students. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility Counseling, Communication Skills
- What is being tested?
- AI-Powered OSCE Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 30 Jul 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
- Undergraduate nursing students enrolled at Bartın University Faculty of Health Sciences
- Successfully completed the Women's Health and Diseases Nursing course (minimum passing grade)
- Currently enrolled in the infertility nursing course
- Able to read and understand Turkish
- Willing to participate and provide written informed consent
Who cannot join
- Students who do not complete the educational intervention
- Students who do not complete pretest or posttest assessments
- Students with prior formal training in AI-supported OSCE or similar simulation-based coaching programs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bartın University
Merkez, Bartın, (741) 00_-____
About this study
Official title: AI-Powered OSCE Coaching in Improving Infertility Counseling Skills: A Randomized Controlled Study in Nursing Students
This randomized controlled experimental study aims to evaluate the effectiveness of a generative artificial intelligence-based "OSCE Coach" in improving infertility counseling communication and empathy skills among nursing students. The study will be conducted with undergraduate nursing students at Bartın University Faculty of Health Sciences and follows a two-group pretest-posttest design.
A total of 72 students will be randomly assigned to either the intervention group or the control group using computer-generated randomization. The intervention group will participate in an AI-powered OSCE coaching simulation consisting of 6-8 infertility counseling micro-scenarios, incorporating structured feedback and deliberate practice cycles. The control group will receive conventional infertility counseling education using standard teaching methods.
Read more
Outcomes will be assessed using the Therapeutic Communication Skills Scale for Nursing Students, the Jefferson Scale of Empathy for Nursing Students, and a rubric-based infertility counseling communication performance assessment based on the Kalamazoo Consensus Statement. Performance evaluations will be conducted via standardized virtual patient interviews and scored by two blinded independent raters.
Data will be analyzed using ANCOVA to assess intervention effects while controlling for baseline scores. This study aims to contribute evidence on the effectiveness of AI-supported OSCE coaching in enhancing communication and empathy skills in nursing education.
Read the detailed description
This study is designed as a two-group, randomized controlled experimental trial with a pretest-posttest design to evaluate the effectiveness of a generative artificial intelligence-based "OSCE Coach" in improving infertility counseling communication and empathy skills among nursing students. The study will be conducted at Bartın University Faculty of Health Sciences, Department of Nursing, following approval from the Bartın University Social and Humanities Ethics Committee and in accordance with the principles of the Declaration of Helsinki.
The study population will consist of undergraduate nursing students who are actively enrolled in the infertility nursing course and have successfully completed the women's health and diseases nursing course. Eligible participants who provide written informed consent will be randomly assigned to either the intervention group or the control group using a computer-generated randomization sequence. Allocation will be performed by an independent individual not involved in data collection or analysis. Due to the nature of the educational intervention, participant blinding will not be possible; however, outcome assessors evaluating OSCE performance will be blinded to group allocation.
The intervention group will receive training through a generative artificial intelligence-based "OSCE Coach" designed to support deliberate practice in infertility counseling communication. The intervention consists of 6-8 structured micro-scenarios reflecting common and challenging infertility counseling situations, including establishing rapport, psychosocial assessment, managing emotional reactions, addressing partner-related concerns, responding to social stigma, providing clear information, delivering difficult news, and closing the counseling session. In each scenario, participants will provide written counseling responses, which will be analyzed by the AI system based on therapeutic communication and empathy principles. Structured, rubric-based feedback will be provided, allowing participants to revise and repeat their responses in a deliberate practice cycle.
The control group will receive conventional infertility counseling education delivered through standard teaching methods, including lectures, written case discussions, and review of example counseling dialogues. The duration and overall educational workload of the control condition will be matched to that of the intervention group to ensure comparability between groups. No AI-supported simulation or interactive feedback will be used in the control group.
Outcome assessment will be conducted using validated self-report scales and a standardized performance-based evaluation. Therapeutic communication skills will be measured using the Therapeutic Communication Skills Scale for Nursing Students, and empathy levels will be assessed using the Jefferson Scale of Empathy for Nursing Students. Counseling performance will be evaluated through standardized virtual patient interviews conducted in an examination-mode simulation environment. All participants will complete the same virtual patient scenario under identical conditions. Performances will be scored independently by two trained evaluators using a rubric developed based on the Kalamazoo Consensus Statement. Evaluators will be blinded to participants' group assignments, and inter-rater reliability will be assessed using the intraclass correlation coefficient.
Pretest assessments will be conducted prior to the educational intervention, and posttest assessments will be completed after the intervention period. Data will be analyzed using appropriate parametric or non-parametric statistical methods based on data distribution. Analysis of covariance (ANCOVA) will be used to evaluate intervention effects while controlling for baseline scores. Effect sizes will be calculated, and statistical significance will be set at p < 0.05.
All participant data will be anonymized using unique identification codes. Only the research team will have access to the data, which will be stored securely and used solely for scientific purposes. Participants will have the right to withdraw from the study at any time without penalty. Upon completion of the study, students in the control group will be offered optional access to the AI-based OSCE coaching system in line with ethical considerations.
- Conditions
- Infertility Counseling, Communication Skills
- Being tested
- AI-Powered OSCE Coaching
- Keywords
- Infertility counseling, nursing education, artificial intelligence, OSCE, therapeutic communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Powered OSCE CoachingBehavioural
Participants receive a generative artificial intelligence-supported OSCE coaching intervention designed to improve infertility counseling communication and empathy skills. The intervention consists of 6-8 structured micro-scenarios reflecting common infertility counseling situations. For each scenario, participants provide written counseling responses, which are analyzed by the AI system based on therapeutic communication and empathy principles. Automated, structured feedback is provided, allowing participants to revise and repeat responses in a deliberate practice cycle. The intervention is delivered individually and does not involve real patients.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants receive generative AI-supported OSCE coaching using structured infertility counseling scenarios with automated feedback and deliberate practice. Receives: Behavioral: AI-Powered OSCE Coaching |
| control | No intervention | No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infertility Counseling Communication Performance
Counseling communication performance assessed through standardized virtual patient interviews using a rubric-based evaluation tool developed based on the Kalamazoo Consensus Statement. Performances are independently scored by two blinded evaluators, and the average score is used for analysis.
Measured: Post-intervention (immediately after completion of the AI-powered OSCE coaching or conventional training)
Secondary outcomes (2)
Therapeutic Communication Skills
Measured using the Therapeutic Communication Skills Scale for Nursing Students. Total scores range from 16 to 112, with higher scores indicating better therapeutic communication skills.
Measured: Baseline (prior to intervention) and post-intervention (immediately after completion of the intervention)
Clinical Empathy Level
Measured using the Jefferson Scale of Empathy for Nursing Students. Total scores range from 18 to 126, with higher scores indicating higher empathy levels.
Measured: Baseline (prior to intervention) and post-intervention (immediately after completion of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Mar 2026
- Primary completion30 Jun 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility CounselingStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜLESER ADA, Bartın Unıversity
- Investigators
- Ebru CİRBAN EKREM, PhD, Study director, Bartın UnıversityHarun İlçioğlu, PhD, Principal investigator, Kastamonu UniversityKevser İlçioğlu, PhD, Principal investigator, sakarya üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404020
- Sponsor's protocol ID
- BARU-SBF-OSCE-AI-2026
- Acronym
- AI-OSCE-Infert
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Sep 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Powered OSCE Coaching in Improving Infertility Counseling Skills: A Randomized Controlled Study in Nursing Students
- ClinicalTrials.gov ID
- NCT07404020
- Acronym / sponsor ID
- AI-OSCE-Infert / BARU-SBF-OSCE-AI-2026
- Conditions
- Infertility Counseling, Communication Skills
- Keywords
- Infertility counseling, nursing education, artificial intelligence, OSCE, therapeutic communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 11 Feb 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.
This randomized controlled experimental study aims to evaluate the effectiveness of a generative artificial intelligence-based "OSCE Coach" in improving infertility counseling communication and empathy skills among nursing students. The study will be conducted with undergraduate nursing students at Bartın University Faculty of Health Sciences and follows a two-group pretest-posttest design.
A total of 72 students will be randomly assigned to either the intervention group or the control group using computer-generated randomization. The intervention group will participate in an AI-powered OSCE coaching simulation consisting of 6-8 infertility counseling micro-scenarios, incorporating structured feedback and deliberate practice cycles. The control group will receive conventional infertility counseling education using standard teaching methods.
Outcomes will be assessed using the Therapeutic Communication Skills Scale for Nursing Students, the Jefferson Scale of Empathy for Nursing Students, and a rubric-based infertility counseling communication performance assessment based on the Kalamazoo Consensus Statement. Performance evaluations will be conducted via standardized virtual patient interviews and scored by two blinded independent raters.
Data will be analyzed using ANCOVA to assess intervention effects while controlling for baseline scores. This study aims to contribute evidence on the effectiveness of AI-supported OSCE coaching in enhancing communication and empathy skills in nursing education.
Detailed description
This study is designed as a two-group, randomized controlled experimental trial with a pretest-posttest design to evaluate the effectiveness of a generative artificial intelligence-based "OSCE Coach" in improving infertility counseling communication and empathy skills among nursing students. The study will be conducted at Bartın University Faculty of Health Sciences, Department of Nursing, following approval from the Bartın University Social and Humanities Ethics Committee and in accordance with the principles of the Declaration of Helsinki.
The study population will consist of undergraduate nursing students who are actively enrolled in the infertility nursing course and have successfully completed the women's health and diseases nursing course. Eligible participants who provide written informed consent will be randomly assigned to either the intervention group or the control group using a computer-generated randomization sequence. Allocation will be performed by an independent individual not involved in data collection or analysis. Due to the nature of the educational intervention, participant blinding will not be possible; however, outcome assessors evaluating OSCE performance will be blinded to group allocation.
The intervention group will receive training through a generative artificial intelligence-based "OSCE Coach" designed to support deliberate practice in infertility counseling communication. The intervention consists of 6-8 structured micro-scenarios reflecting common and challenging infertility counseling situations, including establishing rapport, psychosocial assessment, managing emotional reactions, addressing partner-related concerns, responding to social stigma, providing clear information, delivering difficult news, and closing the counseling session. In each scenario, participants will provide written counseling responses, which will be analyzed by the AI system based on therapeutic communication and empathy principles. Structured, rubric-based feedback will be provided, allowing participants to revise and repeat their responses in a deliberate practice cycle.
The control group will receive conventional infertility counseling education delivered through standard teaching methods, including lectures, written case discussions, and review of example counseling dialogues. The duration and overall educational workload of the control condition will be matched to that of the intervention group to ensure comparability between groups. No AI-supported simulation or interactive feedback will be used in the control group.
Outcome assessment will be conducted using validated self-report scales and a standardized performance-based evaluation. Therapeutic communication skills will be measured using the Therapeutic Communication Skills Scale for Nursing Students, and empathy levels will be assessed using the Jefferson Scale of Empathy for Nursing Students. Counseling performance will be evaluated through standardized virtual patient interviews conducted in an examination-mode simulation environment. All participants will complete the same virtual patient scenario under identical conditions. Performances will be scored independently by two trained evaluators using a rubric developed based on the Kalamazoo Consensus Statement. Evaluators will be blinded to participants' group assignments, and inter-rater reliability will be assessed using the intraclass correlation coefficient.
Pretest assessments will be conducted prior to the educational intervention, and posttest assessments will be completed after the intervention period. Data will be analyzed using appropriate parametric or non-parametric statistical methods based on data distribution. Analysis of covariance (ANCOVA) will be used to evaluate intervention effects while controlling for baseline scores. Effect sizes will be calculated, and statistical significance will be set at p < 0.05.
All participant data will be anonymized using unique identification codes. Only the research team will have access to the data, which will be stored securely and used solely for scientific purposes. Participants will have the right to withdraw from the study at any time without penalty. Upon completion of the study, students in the control group will be offered optional access to the AI-based OSCE coaching system in line with ethical considerations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: AI-Powered OSCE CoachingParticipants receive generative AI-supported OSCE coaching using structured infertility counseling scenarios with automated feedback and deliberate practice. |
| control | No intervention | –No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergraduate nursing students enrolled at Bartın University Faculty of Health Sciences
- Successfully completed the Women's Health and Diseases Nursing course (minimum passing grade)
- Currently enrolled in the infertility nursing course
- Able to read and understand Turkish
- Willing to participate and provide written informed consent
Key exclusion criteria (3 listed)
- Students who do not complete the educational intervention
- Students who do not complete pretest or posttest assessments
- Students with prior formal training in AI-supported OSCE or similar simulation-based coaching programs
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 OSCE CoachingParticipants receive a generative artificial intelligence-supported OSCE coaching intervention designed to improve infertility counseling communication and empathy skills. The intervention consists of 6-8 structured micro-scenarios reflecting common infertility counseling situations. For each scenario, participants provide written counseling responses, which are analyzed by the AI system based on therapeutic communication and empathy principles. Automated, structured feedback is provided, allowing participants to revise and repeat responses in a deliberate practice cycle. The intervention is delivered individually and does not involve real patients. | Behavioural | Experimental group |
Primary outcome
Infertility Counseling Communication Performance
Time frame: Post-intervention (immediately after completion of the AI-powered OSCE coaching or conventional training)
Counseling communication performance assessed through standardized virtual patient interviews using a rubric-based evaluation tool developed based on the Kalamazoo Consensus Statement. Performances are independently scored by two blinded evaluators, and the average score is used for analysis.
2 secondary outcomes
Therapeutic Communication Skills
Time frame: Baseline (prior to intervention) and post-intervention (immediately after completion of the intervention)
Clinical Empathy Level
Time frame: Baseline (prior to intervention) and post-intervention (immediately after completion of the intervention)
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Ebru CİRBAN EKREM, PhD study director
Bartın Unıversity
Harun İlçioğlu, PhD principal investigator
Kastamonu University
Kevser İlçioğlu, PhD principal investigator
sakarya üniversity
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 OSCE Coaching in people with Infertility Counseling and Communication Skills, run by Sakarya 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 5 inclusion and 3 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 9 Sep 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?
Infertility Counseling Communication Performance (time frame: Post-intervention (immediately after completion of the AI-powered OSCE coaching or conventional training)). 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 9 Sep 2026.