Impact of Conversational Approaches in Pediatric Social Robot-Mediated Interventions

NCT07389902 | Not Yet Recruiting DMC

• 1 other identifier: SMC 2025-09-101-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Patients; Pediatric Patients in Hospital Settings; Hospitalized Children

Keywords

Child-robot interaction; Social robot; Pediatric hospitalization; Large language models; Human-robot interaction; Pediatric care

Outcome Measures

Primary Outcomes (3)

• Child Engagement Level

  Behavioral observation checklist assessing attention to robot, participation in activities, and task involvement. Scored by trained observers using standardized coding scheme based on video recordings.

  Immediately following each intervention session (assessed within 1 hour post-session)

• User Experience

  User Experience Questionnaire (UEQ) - standardized 7-point semantic differential scale measuring six dimensions: attractiveness, perspicuity, efficiency, dependability, stimulation, and novelty of robot interaction.

  Immediately following each intervention session (approximately 5 minutes post-session)

• Robot Perception

  Godspeed Questionnaire Series - standardized scale measuring five dimensions of robot perception: anthropomorphism, animacy, likeability, perceived intelligence, and perceived safety.

  Immediately following each intervention session (approximately 5 minutes post-session)

Secondary Outcomes (4)

• Content Appropriateness

  Within 2 weeks of session completion via video review

• Activity Preference

  Immediately following completion of both intervention sessions (approximately 5 minutes)

• Content Comprehension

  Immediately following each intervention session (approximately 3 minutes)

• Robot Relationship Quality

  Immediately following intervention sessions (approximately 5 minutes)

Study Arms (2)

Rule-Based Robot Dialogue

EXPERIMENTAL

Participants interact with LIKU robot using pre-programmed, rule-based dialogue responses. Each participant completes two activity sessions (emotional support content and safety education content) in randomized order.

Behavioral: Robot-Mediated Emotional Support Activity; Behavioral: Robot-Mediated Safety Education Activity

LLM-Based Robot Dialogue

EXPERIMENTAL

Participants interact with LIKU robot using large language model-generated dialogue responses. Each participant completes two activity sessions (emotional support content and safety education content) in randomized order.

Behavioral: Robot-Mediated Emotional Support Activity; Behavioral: Robot-Mediated Safety Education Activity

Interventions

Robot-Mediated Emotional Support Activity BEHAVIORAL

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

LLM-Based Robot Dialogue; Rule-Based Robot Dialogue

Robot-Mediated Safety Education Activity BEHAVIORAL

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

LLM-Based Robot Dialogue; Rule-Based Robot Dialogue

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Central Study Contacts

Yujin Seo

CONTACT

82+1090603747; yoojin3747@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Between-subjects factor: Robot dialogue type Within-subjects factor: Content type

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)