NCT05896202已完成不适用
Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change Expectation for Pain Relief as Measured by EXPECT Scores
研究概览
简要总结
The purpose of this study is to:
- Development of culturally sensitive videos for enhance informed consent with neurostimulation and determination of factors that influence minority interest in participating in neurostimulation research.
- Examination of the influence that video enhanced informed consent has on expectations with transcutaneous auricular vagus nerve stimulation (taVNS) and on treatment intended effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 18-80 years
- •neuropathic pain lasting longer than 3 months (i.e., complaint of sensation of burning, stabbing or pressing pain, shooting or shock like pain, or paresthesias)
- •Neuropathic Pain Symptom Inventory score ≥
- •self identifies as Black or Hispanic
排除标准
- •any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
- •currently taking Buprenorphine or recently stopped taking (within 1 month)
- •presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
- •implants in the head or neck, cochlear implants, or pacemaker
- •head or neck metastasis or recent ear trauma
- •history of seizures.
结局指标
主要结局
Change Expectation for Pain Relief as Measured by EXPECT Scores
时间窗: Baseline, and up to 90 minutes
The Expectations for Complementary and Alternative Medicine Treatments (EXPECT) is a 4-item questionnaire that assesses expectations for pain improvement. Each of the 4 items is scored on an 11-point scale, with 0 being no change and 10 representing complete relief (scores ranging from 0-10). Higher scores represent greater expectations for pain relief. Scores from all 4 items are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater expectations for pain relief.
次要结局
- Change in Heart Rate Variability (HRV)(Baseline, up to 90 minutes)
研究者
Marlon Wong
Associate Professor of Clinical Physical Therapy
University of Miami
研究点 (2)
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