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Mind-Body Training for Hand Rehabilitation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02459847
Enrollment
21
Registered
2015-06-02
Start date
2014-08-31
Completion date
2015-05-31
Last updated
2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arm Injuries, Hand Injuries

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.

Interventions

BEHAVIORALMindfulness Training
BEHAVIORALSonographic Biofeedback
OTHERStandard Care

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Salivary Cortisol throughout duration of intervention0, 20, 40 and 60 minutes from start of intervention session

Secondary

MeasureTime frameDescription
Change in Visual Analogue Pain Scale throughout duration of intervention0, 20, 40 and 60 minutes from start of intervention session
Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeksBaseline and 2 weeks
Change in State Anxiety Inventory throughout duration of intervention0, 20, 40 and 60 minutes from start of intervention session
Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeksBaseline and 2 weeks
Change from Baseline in Trait Anxiety Inventory at 2 weeksBaseline and 2 weeks
Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (DASH) Outcome Measure at 2 weeksBaseline and 2 weeksThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026