Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2018-05-01
2020-01-22
Brief Summary
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Intervention: a supplemental mindfulness-based intervention (MBI) will be provided to the experimental group while the control group will receive standard care. The MBI will begin with an explanation of the purpose of a mindfulness, how mindfulness relates to hand therapy, and lead to a 20-minute guided meditation using an audio recording.
Objectives: to establish the feasibility of providing a MBI in hand therapy and evaluate preliminary effects of the MBI on patients' stress, anxiety, and depression.
Population: adult patients at an outpatient hand therapy clinic in the Los Angeles area who have received a traumatic injury (e.g., tendon laceration, compound fracture, finger amputation).
Methodology: the study will use a mixed-methods, non-randomized, 2-group, comparative trial design with 40 participants in total. Quantitative data on psychosocial outcomes, including salivary cortisol, will be collected once a week for 4 weeks while patients are attending hand therapy and qualitative interviews will be conducted at the end of the study.
Study arms: the experimental group (n = 20) will receive the MBI just before regularly scheduled standard care visits. The control group (n = 20) will receive only standard care.
Outcomes: this pilot study will be used to inform a future fully powered trial on mindfulness-based interventions in hand therapy. Feasibility and preliminary psychosocial effects of MBIs will be evaluated and used to inform future work.
Analysis: (1) A repeated measures ANOVA for intervention group, time, and time by intervention group effects on the psychosocial outcomes (i.e., Cortisol, Anxiety, Depression, and Pain Catastrophizing). (2) A descriptive qualitative process will be used to analyze themes in participant interview responses.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Mindfulness Meditation plus Hand Therapy
Participants will be recruited from patients suffering from a traumatic injury who are entering hand therapy at a community based clinic in the Los Angeles area.
Mindfulness Meditation
Guided using an mp3 player and noise cancelling headphones, participants will be led through a series of mindfulness meditations lasting approximately 20 minutes each.
Standard Care in Hand Therapy
Participants will be recruited from patients suffering from a traumatic injury who are entering hand therapy at a community based clinic in the Los Angeles area.
No interventions assigned to this group
Interventions
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Mindfulness Meditation
Guided using an mp3 player and noise cancelling headphones, participants will be led through a series of mindfulness meditations lasting approximately 20 minutes each.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
California Foundation for Occupational Therapy
OTHER
University of Southern California
OTHER
Responsible Party
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Shawn Roll
Associate Professor
Principal Investigators
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Shawn C Roll, PhD
Role: STUDY_CHAIR
University of Southern California
Mark E Hardison, MS
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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St. Jude Centers for Rehabilitation & Wellness
Brea, California, United States
University of Southern California
Los Angeles, California, United States
Countries
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References
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Aardal E, Holm AC. Cortisol in saliva--reference ranges and relation to cortisol in serum. Eur J Clin Chem Clin Biochem. 1995 Dec;33(12):927-32. doi: 10.1515/cclm.1995.33.12.927.
Spielberger CD, Vagg PR, Barker LR, Donham GW, Westberry LG. The factor structure of the State-Trait Anxiety Inventory. In CD Spielberger & IG Sarason (Eds.), Stress and anxiety (pp. 244-279). Washington, DC: Hemisphere; 1980.
Radloff, LS. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement 1(3): 385-401, 1977.
Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: Development and validation. Psychological Assessment 7(4): 524 - 532, 1995.
Other Identifiers
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HS-17-00935
Identifier Type: -
Identifier Source: org_study_id