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Набор скоро начнётся NCT07473765

Virtual Reality for Anxiety Management in Persons With Amyotrophic Lateral Sclerosis

Без фазы С лечением ALS (Amyotrophic Lateral Sclerosis)

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 Guided Breathing Exercise.
Кому может быть актуально
Состояния в реестре: ALS (Amyotrophic Lateral Sclerosis). Базовые параметры: Без ограничений · 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Just... Breathe: Virtual Reality Guided Breathing Exercise for Anxiety Management in Amyotrophic Lateral Sclerosis

Обзор

Virtual Reality (VR) is gaining traction as a new and innovative leisure to augment healthcare services. Several benefits of the leisure experience, such as distraction and full sensory immersion, have demonstrated a potential to significantly impact the field of healthcare through pain reduction, anxiety reduction, and is seen as an innovative approach to motor learning. Persons with ALS (pwALS) have a high prevalence of anxiety over the course of their illness, which has a negative impact on their quality of life, and the quality of life of those closest to them. The use of VR for anxiety management and subsequent quality of life improvement has yet to be explored in the ALS population. For individuals with ALS, VR can be both (1) an escape from the reality of living day to day with a progressive fatal diagnosis; and (2) the opportunity to potentially improve anxiety, both of which are linked to the quality of life of individuals living with ALS. Our hypothesis is that a simple and accessible home VR-guided relaxation exercise program can improve subjective anxiety symptoms in a person living with ALS and subsequently improve quality of life.

Подробное описание

Amyotrophic lateral sclerosis (ALS) is a neuromuscular disease characterized by death of motor neurons, resulting in weakness. Aside from motor-related progressive impairment, persons with ALS (pwALS) experience a burden of non-motor symptoms which have major influences on quality of life (QOL). This includes anxiety, found to be only second to function as greatest influence on QOL.

Exploring alternative technologies to improve access to anxiety management strategies for persons with ALS (pwALS) is a worthy endeavor. Virtual Reality (VR) is a technology increasingly used for mental health treatment and within clinical research. Anxiety treatment interventions utilizing VR can include exposure therapy or applied relaxation techniques, two of the more promising treatments for generalized anxiety disorder. The visual presentation of a virtual calm scenario can facilitate a persons' practice and mastery of relaxation, making the experience more vivid and real than the one that most individuals can create using their own imagination and memory.

This study will identify if a simple and accessible home VR guided relaxation exercise program can improve subjective anxiety symptoms in persons living with ALS, subsequently improving quality of life.

At 5 sites across Canada (Fredericton NB, Halifax NS, Kingston ON, Hamilton ON, and Saskatoon SK), persons with Amyotrophic Lateral Sclerosis will be identified by their treating physician and invited to participate during a typical interdisciplinary ALS clinic visit at their respective healthcare centre. Participants will be randomized to receive a virtual reality system for home-based relaxation therapy or to a control group which will receive no intervention. Outcome measurement will be completed at baseline prior to introduction of virtual reality and after every 4 weeks of intervention up to 12 weeks.

This multi-site randomized controlled trial aims to identify if a simple and accessible at-home virtual reality guided relaxation exercise program can improve subjective anxiety symptoms in persons with ALS and subsequently improve quality of life. It is our hope that this project will not only raise mental health awareness in persons with ALS but also provide an accessible and affordable opportunity to manage these overlooked aspects of ALS. This work could potentially be applied to other diagnoses which influence mental health and quality of life if deemed effective

Вмешательства

  • Поведенческое Virtual Reality Guided Breathing Exercise
    Home-based guided breathing exercise using a virtual reality system application.

Первичные конечные точки

  • State Trait Inventory for Cognitive and Somatic Anxiety (STICSA) [Срок оценки: At baseline and repeated at 4 weeks, 8 weeks and 12 weeks.]
Вторичные конечные точки (3)
  • ALS Functional Rating Scale - Revised (ALSFRS-R) [Срок оценки: Baseline and 12 weeks.]
  • ALS-Specific Quality of Life Short Form (ALSSQOL-SF) [Срок оценки: Baseline, 4 weeks, 8 weeks and 12 weeks.]
  • Patient Global Impression of Improvement Scale (PGI-I) [Срок оценки: Completed at 12 week assessment only.]

Критерии участия

Критерии включения

  • Diagnosed with ALS (gold coast or El-Escorial), or ALS variants of flail limb, progressive muscle atrophy, UMN or LMN predominant
  • Able to use VR device with no negative effects (i.e. headaches, vision changes, dizziness, nausea, disorientation)

Критерии исключения

\- Cognitive impairment that impacts ability to participate fully in assessments

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07473765 · 102307 · Chesley Research Fund

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗