Psychosocial Outcomes in Hand Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Exploring Psychosocial Outcomes in Hand Therapy

Conditions
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Hand Injuries

Intervention / Treatment
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* Behavioral: Mindfulness Meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old; newly entering hand therapy, having a diagnosis of distal radius fracture, flexor tendon injury and repair, extensor tendon injury and repair, tramatic finger amputation, or other traumatic injury; established therapy plan of care lasting at least 4 weeks; able to read and with in English; with regular access to a computer. Exclusion Criteria: diagnosed with a severe mental illness; currently an expert in mindfulness practices

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We are using a 2-cohort, nonrandomized comparative design focused on assessing feasibility and acceptability.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation plus Hand Therapy<br>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<br>* Guided using an mp3 player and noise cancelling headphones, participants will be led through a series of mindfulness meditations lasting approximately 20 minutes each.<br>|
| No Intervention: Standard Care in Hand Therapy<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Complementary Medicine, Integrative Health, Hand Therapy