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Набор скоро начнётся NCT07389902

Impact of Conversational Approaches in Pediatric Social Robot-Mediated Interventions

Без фазы С лечением Pediatric Patients Pediatric Patients in Hospital Settings Hospitalized Children

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Robot-Mediated Emotional Support Activity, Robot-Mediated Safety Education Activity.
Кому может быть актуально
Состояния в реестре: Pediatric Patients, Pediatric Patients in Hospital Settings, Hospitalized Children. Базовые параметры: 2 лет — 9 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое 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
  • Поведенческое 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

Первичные конечные точки

  • Child Engagement Level [Срок оценки: Immediately following each intervention session (assessed within 1 hour post-session)]
  • User Experience [Срок оценки: Immediately following each intervention session (approximately 5 minutes post-session)]
  • Robot Perception [Срок оценки: Immediately following each intervention session (approximately 5 minutes post-session)]
Вторичные конечные точки (4)
  • Content Appropriateness [Срок оценки: Within 2 weeks of session completion via video review]
  • Activity Preference [Срок оценки: Immediately following completion of both intervention sessions (approximately 5 minutes)]
  • Content Comprehension [Срок оценки: Immediately following each intervention session (approximately 3 minutes)]
  • Robot Relationship Quality [Срок оценки: Immediately following intervention sessions (approximately 5 minutes)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

South Korea · 1 центр
  • Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT07389902 · SMC 2025-09-101-003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗