Effects of Concept Mapping and AI Dialogue on Flow and Learning Outcomes in Simulation-Based Learning

August 2, 2026 updated by: Yang,Bao-Huan, Chang Gung University of Science and Technology

Exploring the Impact of Flipped Classroom Combined With Concept Mapping and AI Dialogue on Students' Flow Experience and Learning Outcomes in Simulation Scenarios: From Personal Traits to Learning Practices

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Baseline Big Five personality traits will be assessed using the Chinese 15-item Big Five Inventory (BFI-15), including extraversion, agreeableness, conscientiousness, neuroticism, and openness to experience. The five personality traits will be modeled as exogenous predictors of flow experience and learning-related outcomes in the structural equation model. Flow experience will also be examined as a potential mediator between personality traits and learning-related outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Guishan
      • Taoyuan, Guishan, Taiwan, 333324
        • Chang Gung University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ChatGPT-Assisted Preparation Group
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
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.
Active Comparator: Standard Preparation Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pediatric Nursing Knowledge Test Score
Time Frame: From baseline before the intervention to immediately after completion of all three simulation scenarios
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Critical Thinking Disposition Score
Time Frame: From baseline before the intervention to immediately after completion of all three simulation scenarios
Critical thinking disposition will be assessed using a 6-item questionnaire adapted by Lin et al. from Chai et al. Each item is rated from 1 to 5. Total scores range from 6 to 30, with higher scores indicating a greater tendency to evaluate information, consider different perspectives, and use logical and analytical thinking. 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
Change From Baseline in Self-reported Communication Competence Score
Time Frame: From baseline before the intervention to immediately after completion of all three simulation scenarios
Self-reported communication competence will be assessed using the 8-item Communication Competence Scale developed by Li (2013) for nursing students. The scale assesses communication with patients and family members, including initiating communication, establishing therapeutic relationships, using verbal and nonverbal communication, identifying key information, active listening, recognizing emotions, providing health guidance, and organizing communication content. Each item is rated from 1 to 5. Total scores range from 8 to 40, with higher scores indicating greater self-reported communication competence. 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
Change From Baseline in Learning Self-Efficacy Score
Time Frame: From baseline before the intervention to immediately after completion of all three simulation scenarios
Learning self-efficacy will be assessed using the 8-item self-efficacy subscale of the Motivated Strategies for Learning Questionnaire. Each item is rated from 1 to 5. Total scores range from 8 to 40, with higher scores indicating greater confidence in successfully completing the learning tasks. 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
Change From Baseline in Flow Experience Score
Time Frame: From the baseline learning activity before the intervention to immediately after completion of all three simulation scenarios
Flow experience will be assessed using an 8-item questionnaire based on the Flow Experience Scale developed by Pearce et al. The questionnaire assesses perceived control, involvement, enjoyment, immersion, interest, altered perception of time, curiosity, and understanding of the learning activity. Each item is rated from 1 to 5. Total scores range from 8 to 40, with higher scores indicating a greater level of flow experience. The change score will be calculated as the post-intervention score minus the baseline 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
Time Frame: Immediately after each corresponding simulation scenario
Perceived achievement of the learning objectives will be assessed using a researcher-developed 15-item questionnaire covering fever management (4 items), chest physiotherapy (6 items), and epilepsy care (5 items). Each item is rated from 1 to 5. Total scores range from 15 to 75, with higher scores indicating greater perceived achievement of the learning objectives.
Immediately after each corresponding simulation scenario

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Students in the experimental group will be invited to participate in semi-structured interviews to explore their experiences with the ChatGPT-assisted learning approach.
Time Frame: Within 4 weeks after finalization of the course grades
Students' experiences with the learning approach will be explored through semi-structured interviews. The interviews will examine perceived differences from previous learning methods, advantages, learning gains, areas requiring improvement, willingness to use the approach again, and willingness to recommend the approach to students and instructors. Interview recordings will be transcribed and analyzed using thematic analysis. Findings will be reported as themes and subthemes describing students' learning experiences.
Within 4 weeks after finalization of the course grades

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202402091B0 (Other Identifier: Chang Gung Medical Foundation Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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