Clinical Trial: Mind-Body Training for Hand Rehabilitation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Southern California

Current Primary Outcome: Change in Salivary Cortisol throughout duration of intervention [ Time Frame: 0, 20, 40 and 60 minutes from start of intervention session ]

Original Primary Outcome:

  • Change in Salivary Cortisol throughout duration of intervention [ Time Frame: 0, 20, 40 and 60 minutes from start of intervention session ]
  • Change in Visual Analogue Pain Scale throughout duration of intervention [ Time Frame: 0, 20, 40 and 60 minutes from start of intervention session ]
  • Change in State Anxiety Inventory throughout duration of intervention [ Time Frame: 0, 20, 40 and 60 minutes from start of intervention session ]


Current Secondary Outcome:

  • Change in State Anxiety Inventory throughout duration of intervention [ Time Frame: 0, 20, 40 and 60 minutes from start of intervention session ]
  • Change in Visual Analogue Pain Scale throughout duration of intervention [ Time Frame: 0, 20, 40 and 60 minutes from start of intervention session ]
  • Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks [ Time Frame: Baseline and 2 weeks ]
  • Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (DASH) Outcome Measure at 2 weeks [ Time Frame: 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 from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks [ Time Frame: Baseline and 2 weeks ]
  • Change from Baseline in Trait Anxiety Inventory at 2 weeks [ Time Frame: Baseline and 2 weeks ]


Original Secondary Outcome:

  • Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks [ Time Frame: Baseline and 2 weeks ]
  • Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (DASH) Outcome Measure at 2 weeks [ Time Frame: 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 from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks [ Time Frame: Baseline and 2 weeks ]
  • Change from Baseline in Trait Anxiety Inventory at 2 weeks [ Time Frame: Baseline and 2 weeks ]


Information By: University of Southern California

Dates:
Date Received: November 7, 2014
Date Started: August 2014
Date Completion:
Last Updated: March 7, 2017
Last Verified: March 2017