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

Samsung Medical Center

Status: Begins enrollment this month

Conditions: Hospitalized Children; Pediatric Patients; Pediatric Patients in Hospital Settings

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07389902

SMC 2025-09-101-003

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Rule-Based Robot Dialogue

Experimental group

Description:

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.

Treatment:

Behavioral: Robot-Mediated Safety Education Activity

Behavioral: Robot-Mediated Emotional Support Activity

LLM-Based Robot Dialogue

Experimental group

Description:

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.

Treatment:

Behavioral: Robot-Mediated Safety Education Activity

Behavioral: Robot-Mediated Emotional Support Activity