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Completed

NCT Number: NCT02459847

Mind-Body Training for Hand Rehabilitation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USC Keck Hospital Hand Clinic

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Training

Behavioral

Sonographic Biofeedback

Behavioral

Standard care

Other

Primary outcomes

  1. Change in Salivary Cortisol throughout duration of intervention

    Time frame: 0, 20, 40 and 60 minutes from start of intervention session

Secondary outcomes

  1. Change in State Anxiety Inventory throughout duration of intervention

    Time frame: 0, 20, 40 and 60 minutes from start of intervention session

  2. Change in Visual Analogue Pain Scale throughout duration of intervention

    Time frame: 0, 20, 40 and 60 minutes from start of intervention session

  3. Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks

    Time frame: Baseline and 2 weeks

  4. 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.

  5. Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks

    Time frame: Baseline and 2 weeks

  6. Change from Baseline in Trait Anxiety Inventory at 2 weeks

    Time frame: Baseline and 2 weeks

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2015
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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