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治験 NCT07389902 (PRIA)（対象：小児患者、Pediatric Patients in Hospital Settings、入院中の子供）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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Samsung Medical CenterImpact of Conversational Approaches in Pediatric Social Robot-Mediated Interventions (PRIA) 60 無作為化 小児 個別化医療
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07389902 (PRIA) は 介入研究 臨床試験 で、小児患者、Pediatric Patients in Hospital Settings、入院中の子供 に関するものです。現在は 募集準備中 で、2026年2月9日 に開始予定です。60 名の参加者 の募集が計画されています。この試験は Samsung Medical Center によって主導され、2027年7月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月5日 です。
概要
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...
もっと見る公式タイトル
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
疾患名
小児患者Pediatric Patients in Hospital Settings入院中の子供その他の研究識別子
- PRIA
- SMC 2025-09-101-003
NCT番号
開始日
2026-02-09
最終更新日
2026-02-05
終了予定日
2027-07-30
目標参加者数
60
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
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
主目的
支持療法
割付方法
無作為化
介入モデル
ファクトリアル割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的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. | 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 |
実験的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. | 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 |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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) |
参加アシスタント
適格基準
対象年齢
小児
試験の最低年齢
2 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- 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 Center試験中央連絡先
連絡先: Yujin Seo, 82+1090603747, [email protected]
1 1カ国の場所
Samsung Medical Center, Seoul, 06351, South Korea
YUJIN SEO, 連絡先, 01090603747, [email protected]