Mind-Body Training for Hand Rehabilitation
Primary Purpose
Arm Injuries, Hand Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Training
Sonographic Biofeedback
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Arm Injuries
Eligibility Criteria
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
Sites / Locations
- USC Keck Hospital Hand Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mindfulness
Biofeedback
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Salivary Cortisol throughout duration of intervention
Secondary Outcome Measures
Change in State Anxiety Inventory throughout duration of intervention
Change in Visual Analogue Pain Scale throughout duration of intervention
Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks
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.
Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks
Change from Baseline in Trait Anxiety Inventory at 2 weeks
Full Information
NCT ID
NCT02459847
First Posted
November 7, 2014
Last Updated
November 9, 2021
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT02459847
Brief Title
Mind-Body Training for Hand Rehabilitation
Official Title
Effects of Mind-body Interventions on Stress, Anxiety, and Pain in Hand Therapy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arm Injuries, Hand Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
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.
Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training
Intervention Type
Behavioral
Intervention Name(s)
Sonographic Biofeedback
Intervention Type
Other
Intervention Name(s)
Standard Care
Primary Outcome Measure Information:
Title
Change in Salivary Cortisol throughout duration of intervention
Time Frame
0, 20, 40 and 60 minutes from start of intervention session
Secondary Outcome Measure Information:
Title
Change in State Anxiety Inventory throughout duration of intervention
Time Frame
0, 20, 40 and 60 minutes from start of intervention session
Title
Change in Visual Analogue Pain Scale throughout duration of intervention
Time Frame
0, 20, 40 and 60 minutes from start of intervention session
Title
Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks
Time Frame
Baseline and 2 weeks
Title
Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (DASH) Outcome Measure at 2 weeks
Description
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.
Time Frame
Baseline and 2 weeks
Title
Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks
Time Frame
Baseline and 2 weeks
Title
Change from Baseline in Trait Anxiety Inventory at 2 weeks
Time Frame
Baseline and 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn C Roll, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Keck Hospital Hand Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27089297
Citation
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.
Results Reference
background
PubMed Identifier
33244321
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 2020 Jun 9.
Results Reference
result
PubMed Identifier
31762376
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.
Results Reference
result
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Mind-Body Training for Hand Rehabilitation
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