NCT07637461

Brief Summary

This research plan aims to establish an effectiveness assessment system for promoting clinical communication, empathy, and emotion regulation in pediatric nursing students through a combination of AI communication simulation and human library narrative. This study sets five specific objectives:

  1. 1.To develop and implement a pediatric nursing teaching model that integrates AI communication simulation and human library narrative.
  2. 2.To evaluate the effectiveness of this teaching model in improving nursing students' clinical communication skills.
  3. 3.To examine the effectiveness of this teaching intervention in enhancing nursing students' empathy.
  4. 4.To explore the impact of this teaching intervention on nursing students' emotion regulation abilities.
  5. 5.To understand students' learning experiences, feelings, changes in emotion regulation, and suggestions for improvement regarding this integrated teaching intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

May 26, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

May 26, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

Nursing StudentsEmotion RegulationEmpathyAI (Artificial Intelligence)

Outcome Measures

Primary Outcomes (10)

  • Communication Skills Scale-T0

    This assessment evaluates nursing students' communication performance in doctor-patient interactions. The scale covers eight core communication skills, including: guiding patients and their families in their communication, building positive nurse-patient relationships, using verbal and nonverbal skills, clearly conveying key points, active listening, recognizing and responding to emotions, providing appropriate health guidance, and presenting information in a structured manner. The scale uses a five-point Likert scale, ranging from 1 point for "strongly disagree" to 5 points for "strongly agree," with a total score between 8 and 40. Higher scores indicate better communication skills.

    At the beginning of the semester (Baseline)

  • Communication Skills Scale-T1

    Description: This assessment evaluates nursing students' communication performance in doctor-patient interactions. The scale covers eight core communication skills, including: guiding patients and their families in their communication, building positive nurse-patient relationships, using verbal and nonverbal skills, clearly conveying key points, active listening, recognizing and responding to emotions, providing appropriate health guidance, and presenting information in a structured manner. The scale uses a five-point Likert scale, ranging from 1 point for "strongly disagree" to 5 points for "strongly agree," with a total score between 8 and 40. Higher scores indicate better communication skills.

    8-9 Weeks

  • Communication Skills Scale-T2

    Description: This assessment evaluates nursing students' communication performance in doctor-patient interactions. The scale covers eight core communication skills, including: guiding patients and their families in their communication, building positive nurse-patient relationships, using verbal and nonverbal skills, clearly conveying key points, active listening, recognizing and responding to emotions, providing appropriate health guidance, and presenting information in a structured manner. The scale uses a five-point Likert scale, ranging from 1 point for "strongly disagree" to 5 points for "strongly agree," with a total score between 8 and 40. Higher scores indicate better communication skills.

    18 Weeks

  • Jefferson Empathy Scale (Chinese Version - Health Professional Student Edition)-T0

    This study measures nursing students' level of empathy in clinical settings. The scale includes three dimensions: perspective-taking, emotional care, and putting oneself in another's shoes. The scale comprises three dimensions: perspective-taking, emotional concern, and empathy, totaling 20 items, 10 of which are reverse-scored. It uses a seven-point Likert scale (1 = strongly disagree, 7 = strongly agree), with a total score of 20-140. Higher scores indicate better empathy.

    At the beginning of the semester (Baseline)

  • Jefferson Empathy Scale (Chinese Version - Health Professional Student Edition)-T1

    This study measures nursing students' level of empathy in clinical settings. The scale includes three dimensions: perspective-taking, emotional care, and putting oneself in another's shoes. The scale comprises three dimensions: perspective-taking, emotional concern, and empathy, totaling 20 items, 10 of which are reverse-scored. It uses a seven-point Likert scale (1 = strongly disagree, 7 = strongly agree), with a total score of 20-140. Higher scores indicate better empathy.

    8-9 Weeks

  • Jefferson Empathy Scale (Chinese Version - Health Professional Student Edition)-T2

    This study measures nursing students' level of empathy in clinical settings. The scale includes three dimensions: perspective-taking, emotional care, and putting oneself in another's shoes. The scale comprises three dimensions: perspective-taking, emotional concern, and empathy, totaling 20 items, 10 of which are reverse-scored. It uses a seven-point Likert scale (1 = strongly disagree, 7 = strongly agree), with a total score of 20-140. Higher scores indicate better empathy.

    18 Weeks

  • Difficulties in Emotion Regulation Scale-T0

    The assessment of nursing students' difficulties in regulating emotions includes six dimensions: insufficient emotional awareness, difficulty in clarifying emotions, inability to accept emotions, difficulty in controlling impulses, obstruction of goal-oriented behavior, and lack of effective emotion regulation strategies. The scale consists of 36 items, comprising six dimensions: insufficient emotional awareness, difficulty in emotional clarification, inability to accept emotions, difficulty in impulse control, obstruction of goal-oriented behavior, and lack of effective emotion regulation strategies. The scale uses a five-point Likert scale (1 = almost never, 5 = almost always). Many items are reversed; after conversion, higher scores indicate greater difficulty in emotion regulation.

    At the beginning of the semester (Baseline)

  • Difficulties in Emotion Regulation Scale-T1

    The assessment of nursing students' difficulties in regulating emotions includes six dimensions: insufficient emotional awareness, difficulty in clarifying emotions, inability to accept emotions, difficulty in controlling impulses, obstruction of goal-oriented behavior, and lack of effective emotion regulation strategies. The scale consists of 36 items, covering six dimensions: insufficient emotional awareness, difficulty in emotional clarification, inability to accept emotions, difficulty in impulse control, obstruction of goal-oriented behavior, and lack of effective emotion regulation strategies. The scale uses a five-point Likert scale (1 = almost never, 5 = almost always). Many items are reversed; after conversion, higher scores indicate greater difficulty in emotion regulation.

    8-9 Weeks

  • Difficulties in Emotion Regulation Scale-T2

    The assessment of nursing students' difficulties in regulating emotions includes six dimensions: insufficient emotional awareness, difficulty in clarifying emotions, inability to accept emotions, difficulty in controlling impulses, obstruction of goal-oriented behavior, and lack of effective emotion regulation strategies. The scale consists of 36 items, covering six dimensions: insufficient emotional awareness, difficulty in emotional clarification, inability to accept emotions, difficulty in impulse control, obstruction of goal-oriented behavior, and lack of effective emotion regulation strategies. The scale uses a five-point Likert scale (1 = almost never, 5 = almost always). Many items are reversed; after conversion, higher scores indicate greater difficulty in emotion regulation.

    18 Weeks

  • 5R Structured Reflection

    The 5R model provides a clear, phased framework for reflection, helping students transform experiences into learning insights. The 5R structured reflective writing model includes: event description, personal emotional and behavioral reactions, understanding and reasons behind the behavior, connections to past experiences or knowledge, and improvement strategies for future situations. This sequential framework helps students deepen their understanding of situations, become aware of their own emotional reactions, and promote reflection and adjustment of clinical communication behaviors.

    18 Weeks

Secondary Outcomes (1)

  • Focus Group Interviews

    18 Weeks

Study Arms (2)

Traditional pediatric nursing education, based on the current nursing curriculum and internship guid

ACTIVE COMPARATOR

1\. Classroom lectures covering core pediatric nursing theories and content, such as child development stages, common disease care, and basic communication principles. 2. Teacher-guided case discussions and problem-oriented learning. 3. Pediatric clinical internships, where clinical instructors guide students in communicating with and caring for sick children and their families, according to the internship objectives.

Behavioral: Traditional pediatric nursing teaching

Integrating AI-Based Communication Simulation and Human Library Narratives

EXPERIMENTAL

Integrating AI-Based Communication Simulation and Human Library Narratives

Behavioral: Integrating AI-Based Communication Simulation and Human Library Narratives

Interventions

The standard teaching method, based on the current nursing curriculum and internship guidelines, includes: 1. Classroom lectures on core theories and content of pediatric nursing, such as: stages of child development, care of common diseases, and basic communication principles. 2. Teacher-guided case discussions and case-based problem-oriented learning. 3. Pediatric clinical internship, where clinical teachers guide students in communicating with and caring for sick children and their families according to the internship objectives. When students take the mid-semester post-test (T1), they have only received the above-mentioned teaching content and have not yet participated in AI communication simulation exercises or the human library narrative activity course.

Traditional pediatric nursing education, based on the current nursing curriculum and internship guid

The innovative teaching model integrates "AI communication simulation combined with human library narrative," but due to course schedule and teaching venue arrangements.

Integrating AI-Based Communication Simulation and Human Library Narratives

Eligibility Criteria

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

You may qualify if:

  • Must be 18 years of age or older
  • Must have completed required nursing courses including Anatomy, Physical Examination and Assessment (with Laboratory), and Basic Nursing (with Internship)
  • Must be willing to participate in the research and agree to complete the relevant questionnaire.

You may not qualify if:

  • Individuals with mental illness or cognitive impairment that may affect their participation in the research or the reliability of the data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National defense medical university

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Hsiang-Yun Lan, Asst. Prof.

    National Defense Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiang-Yun Yun Lan, Associate. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 9, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations