Psychosocial Outcomes in Hand Therapy

Not Applicable

Completed

• Conditions: Hand Injuries
• Interventions: Behavioral: Mindfulness Meditation

• Registration Number: NCT03458013
• Lead Sponsor: University of Southern California

Brief 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) A descriptive qualitative process will be used to analyze themes in participant interview responses.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-08
• Study Start: 2018-05-01
• Primary Completion: 2020-01-22
• Study Completion: 2020-01-22
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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Exclusion Criteria

• diagnosed with a severe mental illness; currently an expert in mindfulness practices

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Meditation plus Hand Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Baseline Salivary Cortisol Across 4 weeks	Baseline, 1 week, 2 weeks, 3 weeks, 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.

Secondary Outcome Measures

Name	Time	Method
Change in Baseline State Anxiety Across 4 weeks	Baseline, 1 week, 2 weeks, 3 weeks, 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.
Change in Baseline Depression Across 4 weeks	Baseline, 1 week, 2 weeks, 3 weeks, 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.
Change in Baseline Pain Catastrophizing Baseline Across 4 weeks	Baseline, 1 week, 2 weeks, 3 weeks, 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.

Trial Locations

Locations (2)

St. Jude Centers for Rehabilitation & Wellness; 🇺🇸 Brea, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States