Impact of Conversational Approaches in Pediatric Social Robot-Mediated Interventions (PRIA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Patients; Hospitalized Children; Pediatric Patients in Hospital Settings
• Intervention / Treatment: Behavioral: Robot-Mediated Emotional Support Activity; Behavioral: Robot-Mediated Safety Education Activity

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yujin Seo; Phone Number: 82+1090603747; Email: yoojin3747@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 06351
    • Samsung Medical Center
    • Contact: YUJIN SEO; Phone Number: 01090603747; Email: yoojin3747@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rule-Based Robot Dialogue; 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; 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
Experimental: LLM-Based Robot Dialogue; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Content Appropriateness	Expert evaluation using 5-point Likert scale assessing developmental appropriateness, educational fit, robot speech pacing, content clarity, and activity flow. Evaluated by 5 pediatric development experts through video review.	Within 2 weeks of session completion via video review
Activity Preference	Child interview using picture cards to identify preferred activities and content types (emotional support vs safety education). Children select and explain their preferences.	Immediately following completion of both intervention sessions (approximately 5 minutes)
Content Comprehension	Child interview assessing understanding of activity content, key messages, and learning points from each session using age-appropriate questions.	Immediately following each intervention session (approximately 3 minutes)
Robot Relationship Quality	Child interview and behavioral observation assessing perceived intimacy with robot, emotional attachment, social bonding, and willingness to interact with robot again.	Immediately following intervention sessions (approximately 5 minutes)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 9, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Large language models; Social robot; Human-robot interaction; Child-robot interaction; Pediatric hospitalization; Pediatric care
• Other Study ID Numbers: SMC 2025-09-101-003

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