Arm InjuriesNCT02459847
Mind-Body Training for Hand Rehabilitation
A study testing Mindfulness Training and Sonographic Biofeedback in people with Arm Injuries and Hand Injuries, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arm Injuries, Hand Injuries
- What is being tested?
- Mindfulness Training and Sonographic Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cast or open wounds in the distal upper extremity
- Bilateral upper extremity pathology involvement
- Significant visual or hearing deficit
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Keck Hospital Hand Clinic
Los Angeles, California, 90033
About this study
Official title: 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.
Read the 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.
- Conditions
- Arm Injuries, Hand Injuries
- Being tested
- Mindfulness Training, Sonographic Biofeedback, Standard Care
- Medical subject headings
- Arm Injuries, Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
Sonographic BiofeedbackBehavioural
Standard CareOther
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | 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. Receives: Behavioral: Mindfulness Training; Other: Standard Care |
| Biofeedback | Experimental | 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. Receives: Behavioral: Sonographic Biofeedback; Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Cortisol throughout duration of intervention
Measured: 0, 20, 40 and 60 minutes from start of intervention session
Secondary outcomes (6)
Change in State Anxiety Inventory throughout duration of intervention
Measured: 0, 20, 40 and 60 minutes from start of intervention session
Change in Visual Analogue Pain Scale throughout duration of intervention
Measured: 0, 20, 40 and 60 minutes from start of intervention session
Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks
Measured: Baseline and 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.
Measured: Baseline and 2 weeks
Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks
Measured: Baseline and 2 weeks
Change from Baseline in Trait Anxiety Inventory at 2 weeks
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startAug 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arm InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn Roll, University of Southern California
- Investigators
- Shawn C Roll, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459847
- Sponsor's protocol ID
- HS-14-00320
- Other IDs
- Founders Grant
- Status last verified
- Nov 2021
- First submitted
- 7 Nov 2014
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27089297Roll 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.
PubMed 33244321Takata 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.
PubMed 31762376
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mind-body Interventions on Stress, Anxiety, and Pain in Hand Therapy Patients
- ClinicalTrials.gov ID
- NCT02459847
- Acronym / sponsor ID
- HS-14-00320
- Conditions
- Arm Injuries, Hand Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness Training, Other: Standard CareTwo 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. |
| Biofeedback | Experimental | Behavioral: Sonographic Biofeedback, Other: Standard CareTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Cast or open wounds in the distal upper extremity
- Bilateral upper extremity pathology involvement
- Significant visual or hearing deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Training | Behavioural | Mindfulness |
| Sonographic Biofeedback | Behavioural | Biofeedback |
| Standard Care | Other | Biofeedback, Mindfulness |
Primary outcome
Change in Salivary Cortisol throughout duration of intervention
Time frame: 0, 20, 40 and 60 minutes from start of intervention session
6 secondary outcomes
Change in State Anxiety Inventory throughout duration of intervention
Time frame: 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
Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks
Time frame: 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
Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks
Time frame: Baseline and 2 weeks
Change from Baseline in Trait Anxiety Inventory at 2 weeks
Time frame: Baseline and 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Background: PubMed 27089297Hardison 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 publication: PubMed 33244321Roll 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 publication: PubMed 31762376Takata 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn C Roll, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training and Sonographic Biofeedback in people with Arm Injuries and Hand Injuries, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary Cortisol throughout duration of intervention (time frame: 0, 20, 40 and 60 minutes from start of intervention session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02459847, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.