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Набор скоро начнётся NCT07371260

Effects of Virtual Reality With Multisensory Stimulation on Emotional and Behavioral Disorders in Individuals With Acquired Brain Injury and Disability Requiring Institutional Care: a Single Case Experimental Design (SCED) Study.

Без фазы С лечением Brain Injury Virtual Reality Behavior Emotion

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: Virtual reality.
Кому может быть актуально
Состояния в реестре: Brain Injury, Virtual Reality, Behavior, Emotion. Базовые параметры: от 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
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Обзор

Acquired brain injuries (ABIs) frequently cause emotional and behavioral disorders that impair independence and quality of life, particularly in institutions. Virtual reality (VR), already used in various mental and neurological disorders, offers therapeutic potential that remains largely unexplored in this context. Multisensory devices offer enhanced immersion that can potentially increase the relaxation and calming effect. Their use in specialized care home (SCH) could provide additional support for care. The main objective of the study is to measure the effect of an 8-week multisensory VR relaxation program on the most significant emotional and behavioral disorders in adults with acquired brain injury living in SCH. The SCED method with multiple baselines across subjects (ABA) is used with three adult residents with ABCI and behavioral disorders living in SCH. The study consists of three phases (baseline, intervention, follow-up), during which the three main emotional and behavioral disorders of each resident are assessed weekly based on observations made throughout the week. Additional measures include the assessment of the socio-emotional profile by the care team (ECCSEG) and the emotional distress experienced by residents (QOLIBRI), collected twice per phase. The intervention consists of eight weeks of VR relaxation (VirtySens®), with two 15-minute sessions per week. All measurements taken during the experiment will be anonymized and used only by the investigators, who are fully aware of the European GDPR (General Data Protection Regulation) concerning the protection of personal data.

Вмешательства

  • Другое Virtual reality
    The intervention will consist of 8 weeks with two weekly virtual relaxation sessions using the VirtySens® multisensory device, lasting 15 to 20 minutes.

Первичные конечные точки

  • NPI-ES [Срок оценки: Twice a week, for 21 weeks]
Вторичные конечные точки (5)
  • ECCSEG : The Geneva Scale of Socio-Emotional Behavior Changes [Срок оценки: in the middle and at the end of each phase of the SCED (baseline, intervention, follow-up). 6 evaluations]
  • The QOLIBRI Emotion Questionnaire [Срок оценки: Twice at baseline, twice during the intervention, and twice during follow-up (6 evaluations).]
  • Sensory capsule satisfaction survey [Срок оценки: Twice during the intervention]
  • The Simulator Sickness Questionnaire (SSQ) [Срок оценки: Twice during the intervention]
  • The RV Presence Questionnaire [Срок оценки: Twice during the intervention]

Критерии участия

Критерии включения

  • Resident aged over 18
  • Diagnosis of stroke, traumatic brain injury, tumor, or cerebral anoxia for more than 3 years.
  • Living in a nursing home for at least 6 months
  • Presence of one or more emotional and behavioral disorders during initial assessments (NPI-ES) for at least 3 months.
  • Sufficient cognitive abilities to understand instructions and answer questions using a Likert scale.
  • Normal or corrected visual acuity
  • Resident affiliated with the social security system

Критерии исключения

  • Motor or sensory disorders incompatible with the use of VR
  • Unstabilized photosensitive epilepsy or presence of a seizure in the past year
  • Change in the prescription of neuroleptic treatments, antidepressants, benzodiazepines, sedatives, anxiolytics, mood stabilizers, antiepileptics, or betablockers within the last 3 months.
  • Unstabilized major psychiatric disorders.
  • Craniectomy
  • Limited range of cervical movement due to orthopedic disorders
  • Moderate or severe hearing loss not compensated by a hearing aid
  • Anosmia
  • Asthma
  • Pregnant women or women suspected of being pregnant
  • Breastfeeding women
  • Neurocognitive disorders preventing understanding of instructions during assessments
  • The resident is included in another research protocol

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
Лечение

Центры проведения

Франция · 1 центр
  • Hôpital La Musse — Saint-Sébastien-de-Morsent

Идентификаторы

NCT: NCT07371260 · 2025-A02119-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗