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Набор скоро начнётся NCT07645950

Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy

— Наблюдательное Pediatric Oncology Radiotherapy Parent

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pediatric Oncology, Radiotherapy, Parent. Базовые параметры: от 4 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Pediatric radiotherapy is an anxiety-provoking situation that can, on one hand, impair the child's cooperation and require sedation, and on the other hand,burden the care pathway by generating significant anxiety in both the child and their parents. Companion robots represent an innovative avenue for patient support, but they have never been evaluated in the context of radiotherapy. This study examines the effect of MIROKI, the first social robot capable of communication through a Large Multimodal Model (LMM), on children's state anxiety during radiotherapy. An experimental single-case design (SCED) will compare phases with and without the robot (withdrawal/reversal), both in the waiting room and in the irradiation bunker. The primary outcome variable is anxiety, assessed in several ways: through questionnaires at the beginning and end of treatment; through an objective measure of cardiac activity (heart rate in bpm) during the radiotherapy session, with or without the MIROKI robot; and through an observational grid assessing the child's behavior. The intensive repeated measure (bpm) constitutes the preferred variable in this SCED design, while behavioral observation and anxiety questionnaires will support interpretation. The results could pave the way for reducing sedation and improving the overall care pathway in pediatric radiotherapy.

Первичные конечные точки

  • To evaluate the immediate intra-individual effect of MIROKI on a physiological marker of anxiety in children undergoing radiotherapy. [Срок оценки: During the treatment, across the 6 radiotherapy sessions]
Вторичные конечные точки (5)
  • Evaluate the immediate intra-individual effect of MIROKI in children on: Psychological distress level [Срок оценки: administered before the start of treatment and after completion of treatment]
  • Evaluate the immediate intra-individual effect of MIROKI in children on development of attachment and reassurance [Срок оценки: Before, during, and after treatment]
  • Evaluate the satisfaction with care (radiotherapy at ICM) at the end of treatment [Срок оценки: At the end of treatment]
  • Evaluate the impact of MIROKI on the radiotherapy process: Setup time during sessions in the radiotherapy room [Срок оценки: From the beginning to the end of the treatment course]
  • Evaluate the impact of MIROKI on parents: - Anxiety level - Satisfaction with care at the end of treatment - Experience of the radiotherapy process at the end of treatment [Срок оценки: Before the start , during and after the treatment,]

Критерии участия

Критерии включения

  • Children aged 4 to 18 years, distributed across the following age groups: 4-7 years, 8-12 years, and 13-18 years.
  • Child with an indication for radiotherapy treatment at ICM.
  • Child who speaks French.
  • Child accompanied by a parent or legal guardian who agrees to participate in the study and provide consent.
  • Child covered by the French national health insurance system.

Критерии исключения

6\. Child with a diagnosed neurodevelopmental disorder as a comorbidity. 7. Child with postoperative cognitive sequelae that make interaction during care difficult (e.g., language impairment). 8. Total body irradiation. 9. Child under legal protection, unable to express assent, or presenting major difficulties in understanding the study information. Parent Inclusion Criteria

  • Parent of a child enrolled in the study.
  • Able to speak French.
  • Willing to participate in the study. Parent Exclusion Criteria

1\. Parents or legal representatives under legal protection, or presenting an inability to consent or to understand the study information, making it impossible to provide free and informed consent for the minor's participation.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Франция · 1 центр
  • Julien Welmant — Montpellier

Идентификаторы

NCT: NCT07645950 · PROICM 2026-01 KOK

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗