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Not yet recruiting NCT07389902

Impact of Conversational Approaches in Pediatric Social Robot-Mediated Interventions

No phase Interventional Pediatric Patients Pediatric Patients in Hospital Settings Hospitalized Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot-Mediated Emotional Support Activity, Robot-Mediated Safety Education Activity.
Who it may be relevant to
Registry conditions: Pediatric Patients, Pediatric Patients in Hospital Settings, Hospitalized Children. Basic parameters: 2 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Impact of Conversational Approaches in Pediatric Robot-Mediated Interventions on Children's Responses in Hospital Settings: A Comparative Study of Rule-Based vs. LLM-Based Systems

Overview

This study examines how different robot dialogue systems (rule-based vs. large language model-based) and content types (emotional support vs. safety education) affect pediatric patients' responses during hospital-based robot-mediated interventions. Approximately 60 pediatric patients aged 2-9 years will be randomly assigned to interact with a social robot (LIKU) using either rule-based or LLM-based dialogue. Each child will participate in two activity sessions (emotional content and safety content) in randomized order. Primary outcomes include child engagement, emotional responses, robot perception, and activity preferences, assessed through standardized questionnaires (UEQ, Godspeed), child interviews, and behavioral observations. Additionally, 5 experts will evaluate content appropriateness and safety. This pilot study aims to provide foundational data for developing personalized pediatric robot programs in hospital settings, optimizing both dialogue approaches and content design based on individual child characteristics.

Interventions

  • Behavioral Robot-Mediated Emotional Support Activity
    10-15 minute structured activity focusing on emotional recognition, expression, and regulation through storytelling, discussion, and artistic activities (drawing, physical expression) with the LIKU social robot
  • Behavioral Robot-Mediated Safety Education Activity
    10-15 minute structured activity focusing on safety awareness and emergency response behaviors through educational videos, discussions, and hands-on activities (crafts, physical practice) with the LIKU social robot

Primary outcome measures

  • Child Engagement Level [Time frame: Immediately following each intervention session (assessed within 1 hour post-session)]
  • User Experience [Time frame: Immediately following each intervention session (approximately 5 minutes post-session)]
  • Robot Perception [Time frame: Immediately following each intervention session (approximately 5 minutes post-session)]
Secondary outcome measures (4)
  • Content Appropriateness [Time frame: Within 2 weeks of session completion via video review]
  • Activity Preference [Time frame: Immediately following completion of both intervention sessions (approximately 5 minutes)]
  • Content Comprehension [Time frame: Immediately following each intervention session (approximately 3 minutes)]
  • Robot Relationship Quality [Time frame: Immediately following intervention sessions (approximately 5 minutes)]

Eligibility criteria

Inclusion criteria

  • Pediatric patients aged 2-9 years
  • Currently admitted to or visiting Samsung Medical Center pediatric ward or outpatient clinic
  • Capable of cognitive communication as determined by experienced medical staff
  • Written informed consent from parent/legal guardian obtained
  • Verbal assent from child obtained (developmentally appropriate)
  • Not in acute emergency situation
  • Able to engage in stable interaction for at least 5 minutes in hospital environment

Exclusion criteria

  • Diagnosis of moderate to severe developmental delay (language or cognitive) documented in medical records
  • Currently in isolation treatment (e.g., due to infectious disease)
  • Experiencing acute pain, fever, or medical procedures that make study participation difficult
  • Parent/guardian or child declined participation or withdrew consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Supportive care

Study locations

South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT07389902 · SMC 2025-09-101-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗