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Clinical Trial NCT07389902 (PRIA) for Pediatric Patients, Pediatric Patients in Hospital Settings, Hospitalized Children is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Samsung Medical CenterImpact of Conversational Approaches in Pediatric Social Robot-Mediated Interventions (PRIA) 60 Randomized Pediatric Personalized Treatment
Clinical Trial NCT07389902 (PRIA) is an interventional study for Pediatric Patients, Pediatric Patients in Hospital Settings, Hospitalized Children and is currently not yet recruiting. Enrollment is planned to begin on February 9, 2026 and continue until the study accrues 60 participants. Led by Samsung Medical Center, this study is expected to complete by July 30, 2027. The latest data from ClinicalTrials.gov was last updated on February 5, 2026.
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 ch...
Show MoreOfficial 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
Conditions
Pediatric PatientsPediatric Patients in Hospital SettingsHospitalized ChildrenOther Study IDs
- PRIA
- SMC 2025-09-101-003
NCT ID Number
Start Date (Actual)
2026-02-09
Last Update Posted
2026-02-05
Completion Date (Estimated)
2027-07-30
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Child-robot interaction
Social robot
Pediatric hospitalization
Large language models
Human-robot interaction
Pediatric care
Social robot
Pediatric hospitalization
Large language models
Human-robot interaction
Pediatric care
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Factorial
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalRule-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. | 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 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 |
ExperimentalLLM-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. | 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 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 |
Primary Outcome Measures
Secondary 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) |
| 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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
2 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
- 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
Samsung Medical CenterStudy Central Contact
Contact: Yujin Seo, 82+1090603747, [email protected]
1 Study Locations in 1 Countries
Samsung Medical Center, Seoul, 06351, South Korea
YUJIN SEO, Contact, 01090603747, [email protected]