Mind-Body Training for Hand Rehabilitation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Mind-body Interventions on Stress, Anxiety, and Pain in Hand Therapy Patients

Conditions
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Arm Injuries, Hand Injuries

Intervention / Treatment
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* Behavioral: Mindfulness Training
* Behavioral: Sonographic Biofeedback
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Cast or open wounds in the distal upper extremity Bilateral upper extremity pathology involvement Significant visual or hearing deficit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>Two sessions, each lasting 60-minutes total. The first session involves standard hand therapy care for the entire session. The second session begins with the participant listening to a 19-minute audio-recorded body scan (i.e., mindfulness training), followed by standard care. | Behavioral: Mindfulness Training<br> <br> Other: Standard Care<br> <br> |
| Experimental: Biofeedback<br>Two sessions, each lasting 60-minutes total. The first session involves standard hand therapy care for the entire session. The second session begins with the participant receiving 20 minutes of visual biofeedback training using sonographic imaging (i.e., sonographic biofeedback), followed by standard care. | Behavioral: Sonographic Biofeedback<br> <br> Other: Standard Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Salivary Cortisol throughout duration of intervention |  | 0, 20, 40 and 60 minutes from start of intervention session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in State Anxiety Inventory throughout duration of intervention |  | 0, 20, 40 and 60 minutes from start of intervention session | 
| 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 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 | The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity. | Baseline and 2 weeks | 
| Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks |  | Baseline and 2 weeks | 
| Change from Baseline in Trait Anxiety Inventory at 2 weeks |  | Baseline and 2 weeks |