NCT07748897

Brief Summary

This mixed-methods educational study evaluates the integration of concept mapping and artificial intelligence (AI)-supported dialogue into simulation-based learning for nursing students. The learning activities include structured pre-class preparation, concept mapping, AI-supported dialogue using ChatGPT, and participation in simulated clinical scenarios. The study examines students' flow experience, defined as a state of focused engagement, and their learning outcomes. Quantitative assessments are used to examine critical thinking, self-efficacy, communication skills, and other learning outcomes specified in the study protocol. Interviews and observations are used to explore students' learning processes and experiences. The study also examines whether individual characteristics, including openness and self-efficacy, are associated with learning practices, flow experience, and learning outcomes.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

September 23, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Completed
Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 2, 2026

Last Update Submit

August 2, 2026

Conditions

Keywords

Nursing StudentsSimulation-Based LearningConcept MappingGenerative Artificial IntelligenceFlow ExperienceLearning OutcomesCritical ThinkingSelf-EfficacyCommunication Skills

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Pediatric Nursing Knowledge Test Score

    Pediatric nursing knowledge will be assessed using a test covering fever management for an infant with febrile seizures, chest physiotherapy for a child with pneumonia, and nursing care for a child with epilepsy. Scores range from 0 to 100, with higher scores indicating greater pediatric nursing knowledge. The change score will be calculated as the post-intervention score minus the baseline score.

    From baseline before the intervention to immediately after completion of all three simulation scenarios

Secondary Outcomes (5)

  • Change From Baseline in Critical Thinking Disposition Score

    From baseline before the intervention to immediately after completion of all three simulation scenarios

  • Change From Baseline in Self-reported Communication Competence Score

    From baseline before the intervention to immediately after completion of all three simulation scenarios

  • Change From Baseline in Learning Self-Efficacy Score

    From baseline before the intervention to immediately after completion of all three simulation scenarios

  • Change From Baseline in Flow Experience Score

    From the baseline learning activity before the intervention to immediately after completion of all three simulation scenarios

  • Post-intervention Perceived Learning Objective Achievement Score

    Immediately after each corresponding simulation scenario

Other Outcomes (1)

  • Students in the experimental group will be invited to participate in semi-structured interviews to explore their experiences with the ChatGPT-assisted learning approach.

    Within 4 weeks after finalization of the course grades

Study Arms (2)

ChatGPT-Assisted Preparation Group

EXPERIMENTAL

Classes randomized to this arm will complete preclass preparation for pediatric nursing simulation. Students will watch instructional videos, prepare concept maps, engage in structured dialogue with ChatGPT, and upload their work before class. The preclass activities are intended to improve learning readiness and support efficient participation in the in-class course. During class, students will participate in the same high-fidelity scenario-based simulation, virtual reality learning, and instructor-guided discussion as the comparator group.

Other: ChatGPT-Assisted Preparation for Pediatric Nursing Simulation

Standard Preparation Group

ACTIVE COMPARATOR

Classes randomized to this arm will complete standard preclass preparation for pediatric nursing simulation. Students will watch the same instructional videos, prepare concept maps, and upload their work before class, but will not engage in structured dialogue with ChatGPT. The preclass activities are intended to improve learning readiness and support efficient participation in the in-class course. During class, students will participate in the same high-fidelity scenario-based simulation, virtual reality learning, and instructor-guided discussion as the experimental group.

Other: Standard Preparation for Pediatric Nursing Simulation

Interventions

Students watch instructional videos, prepare concept maps, and engage in structured dialogue with ChatGPT before class. They then participate in high-fidelity pediatric nursing simulation, virtual reality learning, and instructor-guided discussion. The preparation activities are intended to improve learning readiness and support efficient participation in class.

ChatGPT-Assisted Preparation Group

Students watch the same instructional videos and prepare concept maps before class but do not engage in structured dialogue with ChatGPT. They then participate in the same high-fidelity pediatric nursing simulation, virtual reality learning, and instructor-guided discussion as the experimental group.

Standard Preparation Group

Eligibility Criteria

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

You may qualify if:

  • Nursing students enrolled in the participating pediatric nursing course and in one of the classes selected for the study.
  • Aged 18 years or older.
  • Able to read and communicate in Chinese.
  • Willing to provide written informed consent and participate in the study activities and assessments.

You may not qualify if:

  • Previous participation in the pilot testing or development phase of the same instructional program.
  • Students who are on leave of absence or are not expected to attend the scheduled learning activities during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University of Science and Technology

Taoyuan, Guishan, 333324, Taiwan

Location

MeSH Terms

Interventions

Reference Standards

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Four intact classes were selected using convenience sampling. The classes were randomly assigned by lottery at the class level, with two classes assigned to the intervention group and two classes assigned to the control group. All participants within each class received the educational intervention assigned to that class.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 6, 2026

Study Start

September 23, 2025

Primary Completion

September 30, 2026

Study Completion

September 30, 2026

Last Updated

August 6, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations