Effects of Mind-body Interventions on Stress, Anxiety, and Pain in Hand Therapy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in Salivary Cortisol throughout duration of intervention
研究概览
简要总结
The objectives of this pilot study are to: (1) evaluate acute effects of biofeedback and mindfulness training on pain, anxiety, and stress during a hand therapy visit and (2) gain understanding of patient perceptions, preferences, and experiences with mind-body interventions.
详细描述
Each year more than $5.7 billion is spent on outpatient therapy, which is projected to grow 6% annually over the next decade. Subsequently, healthcare reform is mandating more efficient, high-quality care to control spending. Thus, the long-term goal of this work is to develop an integrative health intervention for hand therapy that improves efficiency, enhances outcomes and reduce costs. Biofeedback and mindfulness training are two mind-body interventions that can increase patient engagement and self-efficacy. No research has investigated the integration of these mind-body interventions into treatment for hand therapy patients. This pilot research will explore the acute effects of these techniques in hand therapy patients. This study utilizes a repeated-measures crossover design with 20 participants to explore the effects of mindfulness training and the dynamic biofeedback with sonographic imaging on acute pain, anxiety, and stress. Additionally, the study will evaluate hand therapy patient preferences and perceptions of mind-body techniques. This patient-centered, clinical translational work will provide valuable feasibility data regarding the direct, acute effects of mind-body interventions to inform the development and further study of an integrative hand rehabilitation approach. This responds to a need for best practices for maximizing the mind-body connection and the call to investigate innovative uses of mindfulness to enhance patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Referral to USC Keck Hospital Hand Clinic
- •Upper extremity pathology resulting in decreased hand use
- •Pain with activity greater than 4 out of 10
- •Scheduled to attend at least 2 therapy sessions per week
- •Speak and read English
- •Able to independently read and respond to questionnaires
排除标准
- •Cast or open wounds in the distal upper extremity
- •Bilateral upper extremity pathology involvement
- •Significant visual or hearing deficit
结局指标
主要结局
Change in Salivary Cortisol throughout duration of intervention
时间窗: 0, 20, 40 and 60 minutes from start of intervention session
次要结局
- Change in Visual Analogue Pain Scale throughout duration of intervention(0, 20, 40 and 60 minutes from start of intervention session)
- Change from Baseline in Trait Anxiety Inventory at 2 weeks(Baseline and 2 weeks)
- Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks(Baseline and 2 weeks)
- Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (DASH) Outcome Measure at 2 weeks(Baseline and 2 weeks)
- Change in State Anxiety Inventory throughout duration of intervention(0, 20, 40 and 60 minutes from start of intervention session)
- Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks(Baseline and 2 weeks)
研究者
Shawn Roll
Assistant Professor
University of Southern California