Mind-Body Training for Hand Rehabilitation

November 9, 2021 updated by: Shawn Roll, University of Southern California

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Keck Hospital Hand Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness
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.
Other: Standard Care
Behavioral: Mindfulness Training
Experimental: Biofeedback
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.
Other: Standard Care
Behavioral: Sonographic Biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Salivary Cortisol throughout duration of intervention
Time Frame: 0, 20, 40 and 60 minutes from start of intervention session
0, 20, 40 and 60 minutes from start of intervention session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in State Anxiety Inventory throughout duration of intervention
Time Frame: 0, 20, 40 and 60 minutes from start of intervention session
0, 20, 40 and 60 minutes from start of intervention session
Change in Visual Analogue Pain Scale throughout duration of intervention
Time Frame: 0, 20, 40 and 60 minutes from start of intervention session
0, 20, 40 and 60 minutes from start of intervention session
Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks
Time Frame: Baseline and 2 weeks
Baseline and 2 weeks
Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (DASH) Outcome Measure at 2 weeks
Time Frame: Baseline and 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
Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks
Time Frame: Baseline and 2 weeks
Baseline and 2 weeks
Change from Baseline in Trait Anxiety Inventory at 2 weeks
Time Frame: Baseline and 2 weeks
Baseline and 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Shawn C Roll, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-14-00320
  • Founders Grant (Other Grant/Funding Number: American Society of Hand Therapists)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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