Just... Breathe: Virtual Reality Guided Breathing Exercise for Anxiety Management in Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •- Cognitive impairment that impacts ability to participate fully in assessments
研究组 & 干预措施
Virtual Reality relaxation therapy
Home-based relaxation therapy using a Virtual Reality system with a via guided breathing exercise application.
干预措施: Virtual Reality Guided Breathing Exercise (Behavioral)
Control Group
Persons with ALS will be monitored with the same outcome measures as the intervention group, but no intervention will be provided.
结局指标
主要结局
State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
时间窗: At baseline and repeated at 4 weeks, 8 weeks and 12 weeks.
The STICSA is a self-report questionnaire consisting of 42-items rated on a 4-point Likert scale from 1 (Almost never or Not at all) to 4 (Almost always or Very much so), where 21 items are rating how you feel in the present moment, and the same 21 items are rated based on how you feel in general
次要结局
- ALS Functional Rating Scale - Revised (ALSFRS-R)(Baseline and 12 weeks.)
- ALS-Specific Quality of Life Short Form (ALSSQOL-SF)(Baseline, 4 weeks, 8 weeks and 12 weeks.)
- Patient Global Impression of Improvement Scale (PGI-I)(Completed at 12 week assessment only.)
研究者
Shane McCullum
Clinical Research Manager
Horizon Health Network