An interventional study of Mindfulness Meditation in Hand Injuries, sponsored by University of Southern California. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by University of Southern California · Not applicable, Interventional, and Other
Among 27 studies in Hand Injuries with a site in United States — 8 open to participants now, 8 under way, none of them phase 3. Hand Injuries · United States.
Among the 27 studies in Hand Injuries with a site in United States, this one is the 10th largest by enrollment of the 26 interventional ones that give a count, is one of 2 that started in 2018, is one of 21 with no phase, and was the 11th registered.
122 studies on the registry are indexed under Hand Injuries; 35 are open to participants now.
Browse Hand Injuries studies →8 of the 27 studies in Hand Injuries with a site in United States are open now. Recruiting first, the newest first:
University of Washington · Sites in United States
Ages 22+
University of Missouri-Columbia · Sites in United States
Ages 18+ · Healthy volunteers
Cedars-Sinai Medical Center · Sites in United States
Ages 18–100
NYU Langone Health · Sites in United States
Ages 18–64
Johns Hopkins University · Sites in United States
Ages 18–100
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 26 Hand Injuries studies recruiting now, 14 (54%) set no upper age limit and 10 (38%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 1 · Phase 4 2
First in 2010; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 55 across 97 interventional studies indexed under Hand Injuries.
Median enrollment 30 across the 26 interventional studies, 60 across the 1 observational. Of the 15 that completed or were terminated, 3 (20%) have results posted.
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None of the 27 has an industry lead sponsor. The 10 most frequent:
University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
University of Southern California has 2 studies filed under Hand Injuries — fewer than ten, so there is no comparison to draw.
2 of the studies in Hand Injuries with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05846399University of Missouri-ColumbiaCAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE) | 2027-07-01 |
| NCT07492797Mississippi State UniversityAccessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring | 2027-09-14 |
Among the 27 studies in Hand Injuries with a site in United States, from their registry updates:
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Rationale: there is a need for psychosocial symptom management in hand therapy which has been understudied. Mindfulness-based interventions are used to address psychosocial symptoms in other settings such as chronic injury but have yet to be implemented or explored for patients in acute outpatient rehabilitation.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Mindfulness Meditation
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.
Guided using an mp3 player and noise cancelling headphones, participants will be led through a series of mindfulness meditations lasting approximately 20 minutes each.
Change in Baseline Salivary Cortisol Across 4 weeks
Cortisol is a bio-marker for stress (Aardal \& Holm, 1995). Normal values in healthy adults are sensitive to time of day, but range from 3.5 to 27.0 nmol/l in the morning. Higher salivary cortisol levels are an indicator of higher levels of stress.
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Change in Baseline State Anxiety Across 4 weeks
The State-Trait Anxiety Inventory: State subscale (Spielberger, Vagg, Barker, Donham, \& Westberry, 1980) is scored positively (higher scores equate to higher anxiety) with a minimum score of 20 and a maximum score of 80. Normative data for this scale indicates that a cut point score of 40 and above is considered clinically relevant.
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Change in Baseline Depression Across 4 weeks
Center for Epidemiologic Studies - Depression scale (CES-D; Radloff, 1977), is a 20-item depression scale that is positively scored (higher scores equate to higher depression) ranging from 0 to 60. It is intended for use with the general population with a conservative off is score being greater than 16.
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Change in Baseline Pain Catastrophizing Baseline Across 4 weeks
Pain Catastrophizing Scale (Sullivan, Bishop, \& Pivik, 1995) measures an individual's exaggerated negative psychological response to pain or the anticipation of pain. The scale is scored positively across 13 total items composing 3 subscales: rumination, magnification, and helplessness. These subscales are added together to get the total score from 0 to 52. The middle 50% of scores on this scale fall between 10 and 30 points.
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Plan to share: No
Ran from May 2018 to primary completion in Jan 2020, 20 months.
Of 59 non-industry interventional studies with no phase under Hand Injuries, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 26. This study's 20 months is above that.
Counting every sponsor, half of 59 studies reached it within 14 months; a quarter within 8 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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