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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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_-____

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07404020
Study groupRoleWhat they receive
Experimental groupExperimentalParticipants receive generative AI-supported OSCE coaching using structured infertility counseling scenarios with automated feedback and deliberate practice.
Receives: Behavioral: AI-Powered OSCE Coaching
controlNo interventionNo 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.

  1. 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)
  1. 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)

  2. 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.

  1. First posted11 Feb 2026
  2. Study start1 Mar 2026
  3. Primary completion30 Jun 2026
  4. Study completion30 Jul 2026

Resources

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)
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

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.

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