Mind-Body Training for Hand Rehabilitation

Not Applicable

Completed

• Conditions: Arm Injuries; Hand Injuries
• Interventions: Behavioral: Mindfulness Training; Behavioral: Sonographic Biofeedback; Other: Standard Care

• Registration Number: NCT02459847
• Lead Sponsor: University of Southern California

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-11-07
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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Exclusion Criteria

• Cast or open wounds in the distal upper extremity
• Bilateral upper extremity pathology involvement
• Significant visual or hearing deficit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mindfulness	Mindfulness Training	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.
Biofeedback	Sonographic Biofeedback	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.
Biofeedback	Standard Care	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.
Mindfulness	Standard Care	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.

Primary Outcome Measures

Name	Time	Method
Change in Salivary Cortisol throughout duration of intervention	0, 20, 40 and 60 minutes from start of intervention session

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Trait Anxiety Inventory at 2 weeks	Baseline and 2 weeks
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	Baseline and 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.
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

Trial Locations

Locations (1)

USC Keck Hospital Hand Clinic; 🇺🇸 Los Angeles, California, United States