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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02459847
Other study ID # HS-14-00320
Secondary ID Founders Grant
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date May 2015

Study information

Verified date November 2021
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness Training

Sonographic Biofeedback

Other:
Standard Care


Locations

Country Name City State
United States USC Keck Hospital Hand Clinic Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hardison ME, Roll SC. Mindfulness Interventions in Physical Rehabilitation: A Scoping Review. Am J Occup Ther. 2016 May-Jun;70(3):7003290030p1-9. doi: 10.5014/ajot.2016.018069. Review. — View Citation

Roll SC, Hardison ME, Vigen C, Black DS. Mindful Body Scans and Sonographic Biofeedback as Preparatory Activities to Address Patient Psychological States in Hand Therapy: A Pilot Study. Hand Ther. 2020 Sep;25(3):98-106. doi: 10.1177/1758998320930752. Epub — View Citation

Takata SC, Hardison ME, Roll SC. Fostering Holistic Hand Therapy: Emergent Themes of Client Experiences of Mind-Body Interventions. OTJR (Thorofare N J). 2020 Apr;40(2):122-130. doi: 10.1177/1539449219888835. Epub 2019 Nov 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Salivary Cortisol throughout duration of intervention 0, 20, 40 and 60 minutes from start of intervention session
Secondary Change in State Anxiety Inventory throughout duration of intervention 0, 20, 40 and 60 minutes from start of intervention session
Secondary Change in Visual Analogue Pain Scale throughout duration of intervention 0, 20, 40 and 60 minutes from start of intervention session
Secondary Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks Baseline and 2 weeks
Secondary 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
Secondary Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks Baseline and 2 weeks
Secondary Change from Baseline in Trait Anxiety Inventory at 2 weeks Baseline and 2 weeks
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