Does a Brief Mindfulness Exercise Improve Outcomes in Upper Extremity Patients? A Randomized Controlled Trial.

BACKGROUND: Mindfulness-based interventions are useful in reducing psychologic distress and pain intensity in patients with chronic pain. However, most mindfulness-based interventions are resource-intensive, lengthy, and not feasible for busy orthopaedic surgical practices. QUESTIONS/PURPOSES: The purpose of this study was to determine if a 60-second personalized mindfulness-based video exercise is (1) associated with improved pain intensity, emotional distress, and state anxiety compared with an attention placebo control (a time-matched educational pamphlet about pain and stress); and (2) feasible and acceptable for patients with upper extremity injury in an orthopaedic practice.
METHODS: This was a single-center, single-blind randomized controlled trial of the mindfulness-based video exercise (60 seconds duration, free online) versus an attention placebo control (an educational pamphlet about pain and stress presented to patients to read over 60 seconds). One hundred forty-nine patients presenting for a new or followup appointment at the office of one of two orthopaedic hand and upper extremity outpatient surgical practices at an urban academic hospital were invited to participate between September 2016 and December 2016. Of 149 patients screened, 125 patients were randomized and completed a demographic questionnaire, the Numeric Rating Scale to assess pain intensity, the State Anxiety subscale of the State Trait Anxiety Inventory to assess state anxiety, and Emotion Thermometers to assess anxiety, anger, and depression before and after the interventions. Postintervention, patients also completed the Client Satisfaction Questionnaire Scale-3 to assess the acceptability. A mean score of 21 or higher is considered acceptable. Feasibility was determined based on number of patients approached who refused participation. The intervention was defined as feasible if refusal rate was lower than 25%. Analysis of covariance was used to test comparative improved pain intensity on the NRS, psychologic distress on the Emotion Thermometers, and state anxiety on the State Anxiety Subscale of the State Trait Anxiety Index after controlling for respective baseline scores. A 1-point minimal clinically important difference (MCID) was used on the NRS for pain intensity.
RESULTS: Adjusted for the baseline means, compared with patients who received the attention placebo control, patients who participated in the mindfulness-based video exercise demonstrated improved pain intensity (mindfulness-based video exercise: 3.03 ± 0.12; control: 3.49 ± 0.12; mean difference: 0.46 [0.12-0.80]; p = 0.008); state anxiety (mindfulness-based video exercise: 32.35 ± 0.59; control: 35.29 ± 0.59; mean difference: 2.94 [1.29-4.59]; p = 0.001); anxiety symptoms (mindfulness-based video exercise: 1.49 ± 0.19; control: 2.10 ± 0.19; mean difference: 0.61 [0.08-1.14]; p = 0.024); depression (mindfulness-based video exercise: 1.03 ± 0.10; control: 1.47 ± 0.11; mean difference: 0.44 [0.15-0.73]; p = 0.004); and anger (mindfulness-based video exercise: 0.76 ± 0.12; control: 1.36 ± 0.12; mean difference: 0.60 [0.26-0.94]; p = 0.001). However, the observed differences in pain intensity were below 1 point on the NRS, which is the MCID established in patients with chronic pain. No MCID is available for the other measures. The mindfulness-based video exercise was feasible based on a dropout rate of 0%, and acceptability reached the medium range with similar scores in both groups (mindfulness-based video exercise: 20.70 ± 5.48; control: 20.52 ± 6.42).
CONCLUSIONS: A 60-second mindfulness-based video exercise is feasible to implement and acceptable to patients in busy orthopaedic practices. This video exercise is also effective in improving momentary pain, anxiety, depression, and anger in this population, but it is unclear whether these improved pain and distress levels are meaningful to patients who present with low levels of pain and psychologic distress. Future studies should seek to discern whether the improved pain and distress levels we observed are clinically important or whether the intervention delivers larger effects in subgroups of patients experiencing greater pain intensity and if the improved pain and distress levels are durable. Such studies might also assess cost-effectiveness, because this mindfulness-based tool takes little time and few resources to use, and the effects and durability of multiple sessions of a mindfulness-based video exercise. LEVEL OF EVIDENCE: Level II, therapeutic study.

RCT Entities:   Population Interventions Outcomes