Clinical trial NCT02459847: 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
Overall status: COMPLETED
Phase: NA
Conditions: Arm Injuries
Hand Injuries
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Salivary Cortisol throughout duration of intervention
timeFrame: 0, 20, 40 and 60 minutes from start of intervention session
Secondary outcomes:
measure: Change in State Anxiety Inventory throughout duration of intervention
timeFrame: 0, 20, 40 and 60 minutes from start of intervention session
measure: Change in Visual Analogue Pain Scale throughout duration of intervention
timeFrame: 0, 20, 40 and 60 minutes from start of intervention session
measure: Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (DASH) Outcome Measure at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change from Baseline in Trait Anxiety Inventory at 2 weeks
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Keck Hospital Hand Clinic
state: California
Study officials:
affiliation: University of Southern California
name: Shawn C Roll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.