NCT07404020

Brief 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. 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 96 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

February 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 1, 2026

Last Update Submit

February 7, 2026

Conditions

Keywords

Infertility counselingnursing educationartificial intelligenceOSCEtherapeutic communication

Outcome Measures

Primary Outcomes (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.

    Post-intervention (immediately after completion of the AI-powered OSCE coaching or conventional training)

Secondary Outcomes (2)

  • Therapeutic Communication Skills

    Baseline (prior to intervention) and post-intervention (immediately after completion of the intervention)

  • Clinical Empathy Level

    Baseline (prior to intervention) and post-intervention (immediately after completion of the intervention)

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants receive generative AI-supported OSCE coaching using structured infertility counseling scenarios with automated feedback and deliberate practice.

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.

Interventions

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Merkez, Bartın, (741) 00_-____, Turkey (Türkiye)

Location

Study Officials

  • Ebru CİRBAN EKREM, PhD

    Bartın Unıversity

    STUDY DIRECTOR
  • Harun İlçioğlu, PhD

    Kastamonu University

    PRINCIPAL INVESTIGATOR
  • Kevser İlçioğlu, PhD

    sakarya üniversity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Güleser ADA, PhD

CONTACT

Ebru CİRBAN EKREM, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 11, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations