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Not yet recruitingNCT07389902PRIAUpdated Feb 5, 2026

Impact of Conversational Approaches in Pediatric Social Robot-Mediated Interventions

An interventional study of Robot-Mediated Emotional Support Activity and Robot-Mediated Safety Education Activity in Pediatric Patients, Pediatric Patients in Hospital Settings and Hospitalized Children, sponsored by Samsung Medical Center. Not yet recruiting at 1 site in South Korea. Open to participants aged 2 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
2 Years to 9 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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 · Behavioral: Robot-Mediated Safety Education Activity

  • 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 · Behavioral: Robot-Mediated Safety Education Activity

Interventions

  • BehavioralRobot-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

  • BehavioralRobot-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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. Robot Perception

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

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. Content Comprehension

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

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

  4. Robot Relationship Quality

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

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

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 06351, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07389902
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Feb 5, 2026
Start date
Feb 9, 2026 (estimated)
Primary completion
Jan 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Feb 5, 2026

Study contacts

Yujin Seo
Contact
yoojin3747@gmail.com
82+1090603747

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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