A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing- A Wearable Wellness Brain Sensing Device (Muse-S) in Newly Diagnosed Fibromyalgia Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in Widespread Pain Index (WPI)
研究概览
简要总结
The purpose of this study is to study the feasibility of a wearable brain sensing wellness device to provide mindfulness training to fibromyalgia patients who have failed medical therapy.
详细描述
All study participants will receive a wearable brain sensing wellness device, and demonstration of the mindfulness sessions. Participants will be asked to complete study surveys/questionnaires. During the first part of study, participants will be asked to complete the intervention. After completion of the intervention they will enter a follow-Up Phase, where they will be contacted and asked to complete surveys and gauge satisfaction with the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older at time of consent.
- •Diagnosed with Fibromyalgia.
- •Not pregnant by subject self-report at time of consent.
- •Have the ability to provide informed consent.
- •Have the ability to complete all aspects of this trial.
- •Have access to a iPhone, iPad, Android device.
- •Has no contraindicating comorbid health condition as determined by the clinical investigators.
排除标准
- •Used or been enrolled in any treatments for fibromyalgia, or pain within the past 30 days.
- •Used an investigational drug within the past 30 days.
- •Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
- •Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life.
- •Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress.
- •An unstable medical or mental health condition as determined by the physician investigator.
研究组 & 干预措施
Wearable brain sensing wellness device headband system
Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session.
干预措施: Wearable brain sensing wellness device headband system (Device)
结局指标
主要结局
Change in Widespread Pain Index (WPI)
时间窗: Baseline to end of treatment (day 90)
Wide pain index (WPI) defined as a 4-quadrant plus axial pain, measuring widespread pain in 19 body areas where the patient feels pain over the prior week. Each area identified on the list counts as 1. The range on the WPI score can range from 0 to 19. With lower number indicating fewer areas of pain (hence lower pain). The difference is calculated by taking the baseline score minus the end of treatment score.
Change in Perceived Stress Scale
时间窗: Baseline to end of treatment (day 90)
Measured on a 0-10 pain assessment scale. Participants rate their stress on a scale of 0 to 10. Zero means "no stress," and 10 means "the worst possible stress". The difference is calculated by taking the baseline score minus the end of treatment score.
次要结局
未报告次要终点
研究者
Sanjeev Nanda
Principal Investigator
Mayo Clinic