Pediatric PatientsPRIANCT07389902
Impact of Conversational Approaches in Pediatric Social Robot-Mediated Interventions
A study testing Robot-Mediated Emotional Support Activity and Robot-Mediated Safety Education Activity in people with Pediatric Patients and Pediatric Patients in Hospital Settings, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Patients, Pediatric Patients in Hospital Settings, Hospitalized Children
- What is being tested?
- Robot-Mediated Emotional Support Activity and Robot-Mediated Safety Education Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Feb 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Medical Center
Seoul, 06351
YUJIN SEO, 01090603747, yoojin3747@gmail.com
About this study
Official 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
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.
Read more
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.
- Being tested
- Robot-Mediated Emotional Support Activity, Robot-Mediated Safety Education Activity
- Keywords
- Child-robot interaction, Social robot, Pediatric hospitalization, Large language models, Human-robot interaction, Pediatric care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Mediated Emotional Support ActivityBehavioural
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 ActivityBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Rule-Based Robot Dialogue | Experimental | 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. Receives: Behavioral: Robot-Mediated Emotional Support Activity; Behavioral: Robot-Mediated Safety Education Activity |
| LLM-Based Robot Dialogue | Experimental | 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. Receives: Behavioral: Robot-Mediated Emotional Support Activity; Behavioral: Robot-Mediated Safety Education Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately following each intervention session (approximately 5 minutes post-session)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately following intervention sessions (approximately 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start9 Feb 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric PatientsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Between-subjects factor: Robot dialogue type Within-subjects factor: Content type
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389902
- Sponsor's protocol ID
- SMC 2025-09-101-003
- Acronym
- PRIA
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07389902
- Acronym / sponsor ID
- PRIA / SMC 2025-09-101-003
- Keywords
- Child-robot interaction, Social robot, Pediatric hospitalization, Large language models, Human-robot interaction, Pediatric care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Between-subjects factor: Robot dialogue type Within-subjects factor: Content type
| Arm | Type | Receives |
|---|---|---|
| Rule-Based Robot Dialogue | Experimental | Behavioral: Robot-Mediated Emotional Support Activity, Behavioral: Robot-Mediated Safety Education ActivityParticipants 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. |
| LLM-Based Robot Dialogue | Experimental | Behavioral: Robot-Mediated Emotional Support Activity, Behavioral: Robot-Mediated Safety Education ActivityParticipants 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. |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Mediated Emotional Support Activity10-15 minute structured activity focusing on emotional recognition, expression, and regulation through storytelling, discussion, and artistic activities (drawing, physical expression) with the LIKU social robot | Behavioural | LLM-Based Robot Dialogue, Rule-Based Robot Dialogue |
| Robot-Mediated Safety Education Activity10-15 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 | Behavioural | LLM-Based Robot Dialogue, Rule-Based Robot Dialogue |
Primary outcome
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.
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.
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.
4 secondary outcomes
Content Appropriateness
Time frame: Within 2 weeks of session completion via video review
Activity Preference
Time frame: Immediately following completion of both intervention sessions (approximately 5 minutes)
Content Comprehension
Time frame: Immediately following each intervention session (approximately 3 minutes)
Robot Relationship Quality
Time frame: Immediately following intervention sessions (approximately 5 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Mediated Emotional Support Activity and Robot-Mediated Safety Education Activity in people with Pediatric Patients and Pediatric Patients in Hospital Settings, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yujin Seo (82+1090603747, yoojin3747@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Engagement Level (time frame: Immediately following each intervention session (assessed within 1 hour post-session)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.