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NCT03458013 · ClinicalTrials.gov registry record · NA
Psychosocial Outcomes in Hand Therapy
A NA study, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT03458013 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 40 participants.
The verdict
NCT03458013, a NA study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
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)
Interventions
- BEHAVIORAL Mindfulness Meditation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2020-01-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03458013
The ClinicalTrials.gov registry entry for NCT03458013 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mindfulness Meditation is the first listed.
NCT03458013 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03458013 about?
NCT03458013 is a clinical study titled "Psychosocial Outcomes in Hand Therapy". 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 r...
What is the current status of trial NCT03458013?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2018-05-01. Estimated completion is 2020-01-22.
What interventions are being tested in trial NCT03458013?
The interventions under investigation include: Mindfulness Meditation (BEHAVIORAL).
Who is sponsoring clinical trial NCT03458013?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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