NCT07806396

Brief Summary

This randomized controlled trial evaluated the effects of structured case-based training delivered through an artificial intelligence-supported educational virtual patient chatbot platform on nursing students' gynecological cancer knowledge and self-perceived clinical decision-making. Third-year undergraduate nursing students who had completed the Obstetrics and Gynecology Nursing course were randomly assigned in a 1:1 ratio to an intervention group or an assessment-only wait-list control group. The intervention group completed five AI-supported virtual patient training scenarios during a two-week access period, followed by a common virtual patient assessment. The control group completed the same virtual patient assessment without access to the training scenarios during the study assessment period. Knowledge and self-perceived clinical decision-making were assessed at baseline and immediately after the assigned study procedures. Virtual patient performance was assessed once at the final assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 29, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 2, 2026

Last Update Submit

September 20, 2026

Conditions

Keywords

Artificial IntelligenceChatbotNursing StudentsVirtual PatientGynecologic Oncology

Outcome Measures

Primary Outcomes (1)

  • Change in Clinical Decision Making in Nursing Scale-Turkish Version (CDMNS-Tr) Score

    The CDMNS-Tr is a 40-item scale assessing self-reported clinical decision-making. Items are rated on a 5-point Likert scale ranging from 1 (never) to 5 (always), with eighteen negatively worded items being reverse-scored. Total scores range from 40 to 200, with higher scores indicating a higher self-perception of clinical decision-making abilities.

    Baseline, before access to any group-specific study procedure, and immediately after completion of the assigned study procedures.

Secondary Outcomes (1)

  • Change in Gynecological Oncology Knowledge Test Total Score

    Baseline, before access to any group-specific study procedure, and immediately after completion of the assigned study procedures, within approximately two weeks after baseline.

Study Arms (2)

AI-Supported Virtual Patient Chatbot Training Group

EXPERIMENTAL

Participants received access to five sequential AI-supported educational virtual patient scenarios addressing cervical, endometrial, ovarian, vulvar, and vaginal cancers. The scenarios were completed during a two-week access period. Participants responded in free text, received immediate individualized formative feedback, and were allowed up to three response attempts per scenario. After completing all five training scenarios, participants completed the common virtual patient assessment and the immediate post-intervention outcome assessments.

Other: AI-Supported Educational Virtual Patient Chatbot Platform

Assessment-Only Wait-List Control Group

NO INTERVENTION

Participants did not receive access to the AI-supported training scenarios during the outcome assessment period. They completed the baseline assessments, the same common virtual patient assessment as the intervention group, and the immediate post-assessment knowledge and clinical decision-making measures. After completing all study outcome assessments, they were granted access to the AI-supported educational scenarios.

Interventions

A web-based educational platform integrating structured gynecological oncology scenarios, AI-supported virtual patient interaction, predefined performance criteria, sequential progression, and immediate individualized formative feedback. Participants completed five training scenarios during a two-week access period. The platform used the Claude Sonnet 4 model, API identifier claude-sonnet-4-20250514, throughout the study.

AI-Supported Virtual Patient Chatbot Training Group

Eligibility Criteria

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

You may qualify if:

  • Enrolled as a third-year undergraduate nursing student.
  • Successfully completed the Obstetrics and Gynecology Nursing (Women's Health and Diseases Nursing) course.
  • Volunteered to participate and provided digital informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, Turkey, 54050, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and researchers overseeing the study procedures were aware of group allocation because of the nature of the educational intervention. The researchers independently rating the virtual patient interviews were blinded to group allocation and to the AI-generated scores. Before the primary and secondary analyses, the groups were coded as Group A and Group B, and the data analyst remained blinded to group identity until these analyses had been completed.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 8, 2026

Study Start

June 29, 2026

Primary Completion

August 2, 2026

Study Completion

August 2, 2026

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations