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Идёт набор NCT07202507

Proof-of-Concept Study of the SNOEZELEN Device on Anxiety Symptoms in Patients Hospitalized for Chemotherapy in a Pediatric Oncology Department

Без фазы С лечением Snoezelen Pediatric Cancer Symptomatologie Anxieuse Chimiothérapie

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: self-report questionnaires, research interviews.
Кому может быть актуально
Состояния в реестре: Snoezelen, Pediatric Cancer, Symptomatologie Anxieuse, Chimiothérapie. Базовые параметры: 8 лет — 18 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 →

Обзор

The goal of this clinical trial is to evaluate whether the Snoezelen multisensory relaxation approach can reduce anxiety symptoms in children and adolescents aged 8 to 17 years hospitalized for chemotherapy in a pediatric oncology unit. Researchers will compare patients' symptoms during a chemotherapy cycle with Snoezelen sessions to a previous cycle without Snoezelen, in order to assess changes in psychological and physical well-being. Participants will: * Be enrolled between their first (without Snoezelen) and second (with Snoezelen) chemotherapy cycles * Complete self-report questionnaires on anxiety, depression, quality of life, and nausea * Receive 45-minute Snoezelen sessions every two days during their second hospitalization * Participate in a semi-structured interview after the final session * Provide data on medications (anxiolytics, antiemetics) and vomiting frequency during both hospitalizations

Подробное описание

This is a monocentric proof-of-concept study using mixed methods (quantitative questionnaires and qualitative interviews) to explore the potential benefits of Snoezelen as a supportive care intervention in pediatric oncology.

The goal of this interventional study (minimal risk clinical trial - RIPH2) is to evaluate the effect of the Snoezelen multisensory relaxation approach on anxiety symptoms in children and adolescents aged 8 to 17 years who are hospitalized for chemotherapy in a pediatric oncology unit.

The primary research question is:

\- Does the use of Snoezelen reduce anxiety symptoms during hospitalization for chemotherapy in pediatric cancer patients?

Secondary research questions include:

* Does Snoezelen improve quality of life and reduce depressive symptoms? * Does Snoezelen reduce nausea and vomiting during chemotherapy? Researchers will compare participants' symptoms before and after a chemotherapy cycle with Snoezelen sessions, and contrast these with data from the previous cycle without Snoezelen.

Participants will:

* Be enrolled between their first (without Snoezelen) and second (with Snoezelen) chemotherapy cycles * Complete self-report questionnaires assessing anxiety (GAD-7, SCARED), depression (CDI), quality of life (PedsQL), and nausea (BARF scale) * Receive 45-minute Snoezelen sessions every two days during their second hospitalization for chemotherapy * Participate in a semi-structured research interview after the final Snoezelen session The study will also collect data on medications administered (anxiolytics, antiemetics) and the frequency of vomiting episodes during hospitalization.

Вмешательства

  • Другое self-report questionnaires, research interviews
    self-report questionnaires and research interviews

Первичные конечные точки

  • Semi-structured research interview [Срок оценки: At the end of the 2nd course of chemotherapy and no more than 2 weeks after the last Snoezelen session, 1 month after inclusion]
Вторичные конечные точки (8)
  • Generalized Anxiety Disorder - GAD-7 [Срок оценки: Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months]
  • Anti-emetic treatments [Срок оценки: Periprocedural]
  • Child-Self Report - PedsQL [Срок оценки: Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months]
  • Number of vomits [Срок оценки: Periprocedural]
  • Anxiolytic treatments [Срок оценки: Periprocedural]
  • BARF scale (Baxter Retching Faces) [Срок оценки: Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months]
  • Children's Depression Inventory - CDI [Срок оценки: Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months]
  • Child Anxiety Related Emotional Disorders - SCARED [Срок оценки: Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months]

Критерии участия

Критерии включения

  • New patient
  • Treated in the Paediatrics/AJA department of the Oscar Lambret Centre for cancer (all types of cancer)
  • Hospitalisation for several days
  • Highly emetogenic chemotherapy treatment: this corresponds to all in-patient treatments carried out in the Paediatrics/AJA department.
  • Age at diagnosis : ≥ 8 years and < 18 years.
  • French language
  • Information for the patient and those with parental authority; consent signed by the patient and those with parental authority.
  • Valid social security cover

Критерии исключения

  • Contraindication to SNOEZELEN:
  • Claustrophobia
  • Presence of psychiatric, addictive or cognitive disorders that would prevent compliance with the protocol requirements;
  • State of health not allowing participation in the study (severe fatigue, symptoms refractory to treatment).
  • Pregnant or breast-feeding women

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 1 центр
  • Centre Oscar Lambret — Lille

Идентификаторы

NCT: NCT07202507 · SNOOZE-2501 · 2025-A00760-49

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗