Набор скоро начнётся NCT07089134

Virtual Reality in Intensive Care Unit: Patient Satisfaction, Clinical and Functional Outcomes, Feasibility

Без фазы С лечением Hospitalized Patients ICU Hospitalization Intensive Care Unit-acquired Weakness

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: reabilitação fisioterapêutica tradicional, fisioterapia utilizando realidade virtual imersiva.
Кому может быть актуально: Состояния в реестре: Hospitalized Patients, ICU Hospitalization, Intensive Care Unit-acquired Weakness. 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: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Efficacy of Immersive Virtual Reality Rehabilitation on Patient Satisfaction and Experience, Functional and Clinical Outcomes, and Its Feasibility in Intensive Care Unit Treatment: a Randomized Controlled Trial

Обзор

Background: Virtual reality is recognized as a progressive technology with the potential to enhance the rehabilitation process. Immersive virtual reality-based treatments can improve motor outcomes in physical rehabilitation, reduce stress caused by the intensive care unit environment and maximize patients' recovery processes. Objective: To analyze the efficacy of rehabilitation using immersive virtual reality on patient satisfaction and experience, functional and clinical outcomes and the feasibility of its application during the hospitalization period in an intensive care unit (ICU). Methods: This is a randomized controlled clinical trial involving ICU patients aged 18 years or older, with an estimated ICU stay of ≥ 72 hours, the ability to understand and follow verbal instructions and no diagnosis of psychotic disorders, visual impairment, or hearing loss. Patients will be divided into two groups: one undergoing traditional physiotherapy rehabilitation - control group (CG), and the other receiving physiotherapy using immersive virtual reality (IVR group). The following evaluations will be conducted: mobility condition, physical and psychological discomfort, estimated physical activity level, occurrence of delirium, cognitive decline screening, functionality classification, motivation level, patient experience, sense of immersion in the virtual reality environment, patient satisfaction during the rehabilitation process, occurrence of adverse events, and protocol feasibility. Data will be presented in graphs and tables. Results will be considered statistically significant at a 5% significance level (p ≤ 0.05), and all analyses will be performed using SPSS Statistics version 22. Expected results: The investigators expect to find evidence that rehabilitation using immersive virtual reality can promote and enable a more pleasant and less traumatic experience during the patient's hospitalization, with greater satisfaction and adherence to the proposed rehabilitation, in addition to being an effective tool to optimize patients' functional and clinical outcomes.

Вмешательства

Процедура reabilitação fisioterapêutica tradicional
Active and passive exercises, and walking
Процедура fisioterapia utilizando realidade virtual imersiva
Use of immersive virtual reality headset for rehabilitation sessions

Первичные конечные точки

Patient satisfaction [Срок оценки: Day 1 and day 7 or intensive care unit discharge]
Patient experience: Perceived workload [Срок оценки: Day 1 and day 7 or intensive care unit discharge]
Patient experience: Perceived motivation [Срок оценки: Day 1 and day 7 or intensive care unit discharge]
Patient experience: Perceived presence [Срок оценки: Day 1 and day 7 or intensive care unit discharge]

Вторичные конечные точки (10)

Classification of physical activity level [Срок оценки: Baseline]
Muscle Strength [Срок оценки: Baseline and after 7 days or intensive care unit discharge]
Mobility Assessment [Срок оценки: Baseline and after 7 days or intensive care unit discharge]
Functionality Classification [Срок оценки: Baseline and after 7 days or intensive care unit discharge]
Delirium Assessment [Срок оценки: Up to 7 days or intensive care unit discharge]
Cognitive Function Assessment [Срок оценки: Baseline and after 7 days or intensive care unit discharge]
Assessment of Pain and Psychological Variables [Срок оценки: Baseline and after 7 days or intensive care unit discharge]
Rehabilitation Protocol Feasibility [Срок оценки: After 7 days or intensive care unit discharge]
Adverse Events: Fall risk [Срок оценки: Up to 7 days or intensive care unit discharge]
Adverse Events: Presence of symptoms [Срок оценки: Up to 7 days or intensive care unit discharge]

Критерии участия

Критерии включения

Aged ≥18 years
Glasgow Coma Scale (GCS) score ≥14
Richmond Agitation-Sedation Scale (RASS) score between -1 and +1
Negative for delirium according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Estimated ICU stay of ≥72 hours
Able to communicate in Portuguese
Understand and follow verbal instructions
Have no psychotic disorders, visual impairment or hearing loss.