NCT06891989尚未招募不适用
Effects of a Mobile App-Based Mindfulness Intervention in Persons With Spinal Cord Injury and Chronic Pain: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS).
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
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
- •Traumatic SCI of at least 6 months duration
- •Chronic pain [defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale]
- •Understand spoken and written English sufficiently to provide informed consent, participate in the intervention and complete study surveys
排除标准
- •Lack of daily internet access
- •Inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions about the study
- •Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations
- •Use of any meditation more than once a week in the last 3 months
- •Inability to provide or obtain an email address for registration to the AC intervention and/or communication with study staff
- •Inability to provide a phone number for communication with study staff
研究组 & 干预措施
Mindfulness meditation (MM)
Experimental
干预措施: Mindfulness meditation (MM) Intervention (Other)
Active Control (AC)
Active Comparator
干预措施: Health Education Active Control Intervention (Other)
结局指标
主要结局
Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS).
时间窗: baseline , post-intervention (6 weeks after baseline)
Pain will be measured on Numeric Rating Scale (NRS) from 0(no pain) to 10(pain as bad as you can imagine)
次要结局
- Change in pain interference as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference scale(baseline , post-intervention (6 weeks after baseline))
- Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)(baseline , post-intervention (6 weeks after baseline))
- Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)(baseline , post-intervention (6 weeks after baseline))
研究者
Radha Korupolu
Principal Investigator
Mayo Clinic
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive DisorderDepressionNCT05060393University of Basel140
终止
不适用
Smartphone Mindfulness Meditation for Patients With Rheumatic DiseasesSjogren's SyndromeInflammatory ArthritisVasculitisMyositisSclerodermaSystemic Lupus ErythematosusNCT03937856Johns Hopkins University49
已完成
不适用
Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee OsteoarthritisPainOsteo Arthritis KneeNCT03936088jilliansylvester75
尚未招募
不适用
Mindfulness Intervention for Parents of Children With ASDMindfulnessNCT05746468The University of Hong Kong526
暂停
不适用
Mindfulness Intervention for Caregivers of Autism in Rural EnvironmentsAnxietyStressNCT06169501MaineHealth40