Mind-Body Training for Hand Rehabilitation

Hand Injuries Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Arm Injuries
• Hand Injuries
• Wounds and Injuries

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