Date Presented 4/21/2018
This randomized, crossover pilot study explored the acute effects of mindfulness and visual biofeedback on pain, stress, and anxiety in hand therapy. Reduction in anxiety and trending reduction in stress within the experimental conditions indicate that a future, fully powered trial is warranted.
Primary Author and Speaker: Mark Hardison
Contributing Authors: David Black, Shawn C. Roll
BACKGROUND AND PURPOSE: Each year, more than $5.7 billion is spent on outpatient therapy (Medicare Payment Advisory Commission, 2011), projected to grow 6% annually over the next decade. Health care reform is mandating more efficient, high-quality care to control spending. Thus, the long-term goal of this research was to develop an integrative health intervention for hand therapy that improves efficiency, enhances outcomes, and reduces costs.
Real-time musculoskeletal sonography and mindfulness meditation are two mind–body interventions using biofeedback that can increase patient engagement and self-efficacy. No research has investigated the integration of these mind–body interventions into treatment for hand therapy patients. This pilot study explored the acute effects of mindfulness and visual biofeedback on psychosocial outcomes to inform a future, fully powered randomized trial.
METHOD: The study used a randomized repeated measures crossover design over four hand therapy visits. We recruited English-speaking adults receiving hand therapy at least twice a week from an outpatient hand therapy clinic in Los Angeles. Participants were randomized to two groups with concealed allocation. Visit 1 was standard care (SC), regardless of group. In Visit 2, Group 1 received mindfulness and Group 2 received biofeedback. Visit 3 was SC again. Finally, in Visit 4 groups crossed to receive the other mind–body intervention. The SC condition consisted of an hour-long regular therapy visit. The mindfulness intervention was a 20-min body scan (i.e., a guided meditation) followed by SC. The visual biofeedback intervention was 20 min of real-time musculoskeletal sonography followed by SC.
Primary outcomes included stress measured by salivary cortisol levels (Aardal & Holm, 1995), anxiety measured by the State–Trait Anxiety Inventory (Spielberger et al., 1980), and pain measured using a visual analog scale. Repeated measures were taken at 0, 20, and 60 min over the hour-long interventions. The analytic plan was to test feasibility and use analysis of variance (ANOVA) to evaluate preliminary effects across a visit on cortisol, pain, and anxiety, comparing conditions.
RESULTS: Twenty-one participants were recruited; two dropped out, leaving 19 participants in the final analysis. Participants were representative of sex, varied greatly in age, and most commonly worked full time. An exploratory analysis of the data showed a decrease in all outcomes regardless of intervention across each session. A repeated measures ANOVA demonstrated a significant difference (p < .05) in anxiety comparing Intervention (i.e., SC, mindfulness, or biofeedback) × Time interactions. Also, a trend (p < .10) was observed for changes in cortisol when comparing Intervention × Time interactions.
CONCLUSION: This patient-centered, clinical translational work provided valuable feasibility data regarding the direct, acute effects of mind–body interventions to inform the development and further study of an integrative hand rehabilitation approach.
IMPACT STATEMENT: The observed reduction in anxiety within the mindfulness condition indicates that mindfulness may be useful as a preparatory intervention before standard hand therapy. Moreover, trends show that biofeedback and mindfulness appear to lower cortisol levels more than traditional hand therapy; this is a promising result that may reach significance in a fully powered trial. Together, these results inform the need for continued investigation in a larger study. Moreover, this line of work highlights best practices for maximizing the mind–body connection within hand therapy. Funding source: American Society for Hand Therapists (2014 Founders Grant); NIH/NICHD (K12 HD055929).
References
Aardal, E., & Holm, A.-C. (1995). Cortisol in saliva—Reference ranges and relation to cortisol in serum. European Journal of Clinical Chemistry and Clinical Biochemistry, 33, 927–932. https://doi.org/10.1515/cclm.1995.33.12.927
Medicare Payment Advisory Commission. (2011). Report to the Congress: Medicare payment policy. Washington, DC: Author.
Spielberger, C. D., Vagg, P. R., Barker, L., Donham, G., & Westberry, L. (1980). The factor structure of the State–Trait Anxiety Inventory. Stress and Anxiety, 7, 95–109.