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NCT Number: NCT07389902

Impact of Conversational Approaches in Pediatric Social Robot-Mediated Interventions

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.

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Key information

Conditions

Pediatric Patients Hospitalized Children Pediatric Patients in Hospital Settings

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Child Engagement Level

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

    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.

  2. User Experience

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

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

  3. Robot Perception

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

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

Secondary outcomes

  1. Content Appropriateness

    Time frame: Within 2 weeks of session completion via video review

    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.

  2. Activity Preference

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

    Child interview using picture cards to identify preferred activities and content types (emotional support vs safety education). Children select and explain their preferences.

  3. Content Comprehension

    Time frame: Immediately following each intervention session (approximately 3 minutes)

    Child interview assessing understanding of activity content, key messages, and learning points from each session using age-appropriate questions.

  4. Robot Relationship Quality

    Time frame: Immediately following intervention sessions (approximately 5 minutes)

    Child interview and behavioral observation assessing perceived intimacy with robot, emotional attachment, social bonding, and willingness to interact with robot again.

Study contacts

Contact information is provided by the study sponsor or research team.

Yujin Seo

CONTACT

[email protected]

82+1090603747

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Acronym: PRIA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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