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
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.
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
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University of Southern California