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

Westenberg, Ritsaart, F., MD; Zale, Emily, L., PhD; Heinhuis, Tessa, J., BSc; Özkan, Sezai, MD; Nazzal, Adam, MD; Lee, Sang-Gil, MD; Chen, Neal, C., MD; Vranceanu, Ana-Maria, PhD

Clinical Orthopaedics and Related Research: April 2018 - Volume 476 - Issue 4 - p 790–798
doi: 10.1007/s11999.0000000000000086
SYMPOSIUM: COMPREHENSIVE ORTHOPAEDIC CARE
Free

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.

R. F. Westenberg, S. Özkan, A. Nazzal, S.-G. Lee, N. C. Chen, Hand and Upper Extremity Service, Department of Orthopedic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

E. L. Zale, T. J. Heinhuis, A.-M. Vranceanu, Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

E. L. Zale, Department of Psychology, Syracuse University, Syracuse, NY, USA

S. Özkan, Department of Trauma Surgery, VU University Medical Center, Amsterdam, The Netherlands

A. M. Vranceanu, Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, One Bowdoin Square, Boston, MA 02114, USA, email: avranceanu@mgh.harvard.edu

Each author certifies that neither he or she, nor any member of his or her immediate family, has funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article.

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA-approval status, of any drug or device prior to clinical use.

Each author certifies that his or her institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.

This trial was registered in ClinicalTrials.gov (NCT03212105).

This work was performed at Massachusetts General Hospital, Boston, MA, USA.

Received February 27, 2017

Received in revised form July 11, 2017

Accepted November 20, 2017

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Introduction

Over the last decade, mindfulness-based interventions have demonstrated utility for improving psychologic and pain-related outcomes and the potential to help people who seek care for musculoskeletal pain in orthopaedic surgical practices as an adjunct treatment approach [5, 12, 14, 19, 25, 26, 43-46]. The crux of mindfulness programs is changing one’s relationship with unpleasant thoughts, feelings, and bodily sensations by allowing them to move to the background rather than dictate behaviors. When one learns to place less importance on thoughts, feelings, and bodily sensations through the use of mindfulness, both symptoms and functioning improve [16]. However, traditional mindfulness-based interventions are resource-intensive and not feasible for implementation in busy orthopaedic practices for three main reasons. First, traditional mindfulness-based interventions are typically 8 to 12 weeks long and require a weekly time commitment of 90 to 150 minutes on the part of the patients [16, 46]. Second, mindfulness-based interventions require trained providers, who may not be available in orthopaedic practices nor easily accessible within the larger hospital settings. Third, most mindfulness-based interventions are not covered by insurance companies and are too expensive for most patients.

To overcome the barriers of delivering mindfulness-based care in orthopaedic surgical practices, the potential of a 60-second mindfulness-based video exercise needs to be studied. Such exercise may be feasible during waiting times or in a home-based setting and cost-effective because it does not require a trained provider or additional hospital visits. In addition, it may have the potential to set the tone for a more positive experience for both the patient and provider by at least temporarily lowering the patient’s pain intensity and distress (anxiety, depression, and anger level) when it is delivered before the orthopaedic appointment. Indeed, a growing body of evidence indicates that relaxation and mindfulness-based interventions can decrease psychologic distress, pain, and fatigue during medical procedures and among patients with various types of illnesses [25, 33, 41, 49]. Because musculoskeletal pain intensity has been associated with stress, distress, anxiety, depression, and ineffective coping strategies [10, 31], mindfulness-based interventions may be an efficient treatment to improve pain and distress outcomes. Furthermore, video exercises containing mindfulness tools may be continued at home through the Internet and may motivate patients to learn more about mindfulness. However, it remains unknown what the minimal effective dose (length and frequency) is for mindfulness-based interventions to lower a patient’s distress or pain levels and it has never been tested in patients presenting to orthopaedic surgical practices for musculoskeletal pain [26]. In addition, it is still unknown if such interventions are feasible in an orthopaedic practice and if patients with upper extremity illness appreciate to receive (accept) such a brief intervention of 60 seconds during waiting times.

Therefore, we asked if a 60-second personalized mindfulness-based video exercise is (1) associated with improved pain intensity (primary outcome), psychologic 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.

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Patients and Methods

We conducted a single-center, single-blind randomized controlled trial comprising 125 patients, who were recruited during their regularly scheduled visit at two orthopaedic hand and upper extremity outpatient clinics of an urban academic hospital between September 2016 and December 2016. All new and returning patients were eligible to be screened for inclusion and exclusion criteria. The inclusion criteria were attending an appointment with the orthopaedic upper extremity service for any upper extremity illness. Exclusion criteria included (1) age younger than 18 years; (2) not being fluent and literate in English; (3) pregnancy, per our institutional review board; (4) severe untreated psychopathology by self-report or observation that would interfere with participation in the study; (5) lack of access to the Internet; and (6) not able to provide informed consent. A total of 149 patients were screened for eligibility; 10 declined to participate in the study, 13 were excluded because they did not meet the inclusion criteria (two had severe psychopathology and 11 patients lacked access to the Internet), and one patient was excluded after enrollment, because he was younger than 18 years of age. The total sample of 125 participants was included in the main analyses (Fig. 1).

Fig. 1

Fig. 1

Our participants consisted of 63 men (50%) and 62 women (50%) with a mean age of 55 ± 15 years. The median duration of pain was 8 (interquartile range, 3-25) months with 51 (42%) patients seeking care for traumatic injuries and 74 (59%) seeking care for nontraumatic injuries. In total, 51 patients (42%) had other musculoskeletal pain in addition to the pain concern that motivated their visit to the orthopaedic hand and upper extremity service. There were 12 patients (10%) who reported using narcotic pain medication and 44 patients (35%) who reported using nonnarcotic pain medication. Overall, 57 of the 125 participants (46%) had undergone surgery for their orthopaedic condition at the time of participation. There were no differences in any of the patient demographic characteristics between those who were assigned to the intervention group and those who were in the control group (Table 1).

Table 1

Table 1

After providing informed consent, all participants completed the following baseline measures: a demographic survey (age, gender, race-ethnicity, occupation status, marital status, completed years of education, new or returning patient, date of onset, use of narcotic or nonnarcotic pain medications), a Numerical Rating Scale (NRS) of present pain intensity [9, 22], the State Anxiety Subscale of the State Trait Anxiety Index (STAI) [42], and three different Emotion Thermometers to assess current anxiety, depression, and anger [8].

Next, participants were randomly allocated in a one-to-one ratio to either the intervention or to the attention placebo control group using a computer-generated schedule based on the permuted block randomization method using block sizes of 20 patients [23, 40]. In total, 62 patients were allocated to the control group and 63 patients to the intervention group. All participants were seen in a dedicated room of the outpatient clinic where Internet access was provided and this online-based video exercise could be completed. After completion of the exercise, participants immediately repeated the same set of questionnaires to measure their postintervention levels of pain intensity, psychologic distress (depression, anxiety, and anger), and state anxiety directly after completion of the intervention. After completion of this set of questionnaires, patients filled out the Client Satisfaction Questionnaire Scale-3 (CSQ-3) to measure the acceptability of the intervention. All measures were collected via REDCAP, a secure electronic data capture system, using an encrypted iPad (Apple Inc, Cupertino, CA, USA) or laptop [24]. Participants were kept blind to the intervention by telling them that we are comparing two pain and stress management interventions without saying which intervention we were setting out to test. We used an attention placebo control (a time-matched educational pamphlet about pain and stress) to control for the amount of time and attention of the intervention.

In the intervention group, participants watched a 60-second personalized digital animated video available free of charge on a website (www.pixelthoughts.co). In the attention placebo control group, participants received a brief educational pamphlet that was estimated to take 60 seconds to read. The interventionist (RFW) was a graduate research student with no prior background in mindfulness.

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Description of the Active Intervention

To determine the minimal effective dose for a mindfulness intervention that can be feasible in a busy orthopaedic practice and have the potential to be repeated at home through the Internet, we chose to test a free online 60-second personalized mindfulness-based video exercise. The opening page features a dark blue background with one large, bright star in the middle of the screen and smaller stars that move across the screen. Patients are instructed to generate a thought or feeling that they are having difficulty with in the present moment and to “put the stressful thought into the big star.” Patients are prompted to type their thought such that the text then appears within the star on the screen. Next, patients are instructed to look closely at the big star and to take a deep breath. Over the duration of the 60 seconds, the large star that contains the patient’s stressful thought shrinks such that it becomes evenly sized with the smaller surrounding stars. At the end of the 60-second video, patients are instructed to take a deep breath for a second time. In this specific intervention, patients were instructed to use a thought connected to their orthopaedic musculoskeletal pain. Patients were permitted to complete the exercise privately to avoid any influence by the researcher.

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Attention Placebo Control Group

All patients in the control group were provided a brief educational pamphlet, which is entitled “Pain and stress are interrelated.” Participants were instructed to read the following text on the pamphlet for 60 seconds: “Pain can increase stress. Stress can increase pain intensity. As part of your treatment, being aware of your stress and using healthy coping strategies can help you recover quicker.” The pamphlet also included a diagram informing patients about “what stress does in our body.” The interventionist timed the process and requested the patient to stop reading the pamphlet and continue with the questionnaire after 60 seconds.

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Outcome Measures

Numeric Rating Scale

The NRS is a commonly used, validated, and reliable measure of pain intensity [9, 11, 20-22]. This self-report and graphically administered NRS consists of one item, which is rated on an 11-point scale assessing current pain intensity from 0 (“no pain at all”) to 10 (“the worst pain imaginable”). A 1-point change is considered a minimal clinically important difference (MCID) for patients with musculoskeletal pain [37].

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Emotion Thermometer

The Emotion Thermometer is a validated, reliable instrument that utilizes an 11-point visual analog scale from 0 (“no symptoms”) to 10 (“severe symptoms”) [8, 32, 35, 39]. Patients completed three separate Emotion Thermometers for anxiety, depression, and anger. There is no MCID established for the Emotion Thermometers; therefore, although we could examine mean group differences, we do not know how much of a change is needed to be perceived by the typical patient as clinically important.

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State Trait Anxiety Inventory for Adults–Form Y-1

The self-report measurement STAI for Adults-Form Y-1 is a validated and reliable instrument to assess anxiety [28, 36, 38]. Patients completed the 20-item State Subscale, which assesses momentary (ie, state) anxiety. All items are rated on a 4-point Likert scale from 1 (“not at all”) to 4 (“very much so”). Scores on the STAI State Subscale range from 20 to 80 with higher scores indicating higher levels of state anxiety [42]. There is no MCID established for the Emotion Thermometers; therefore, although we could examine mean group differences, we do not know how much of a change is needed to be perceived by the typical patient as clinically important.

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Feasibility

Feasibility was determined based on the dropout rate (ie, the number of enrolled patients who did not complete the video exercise and postintervention measures) with a dropout rate < 25% considered feasible for the intervention.

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Acceptability

The CSQ-3 was used to examine the acceptability of the video exercise. The CSQ-3 is a short three-item questionnaire based on items 3, 7, and 8 of the parent CSQ-8, which have the highest correlation with satisfaction based on the CSQ-8 [3, 4, 29]. Because an individual item score of 2 is defined as “mildly dissatisfied or indifferent” and a score of 3 as “mostly satisfied,” we used a median split of the scale, mean of 21 or higher, to determine the CSQ-3 value for acceptability, which is consistent with prior methodology [47]. CSQ-3 scores are divided into three levels: low = 8 to 20 points, medium = 21 to 26 points, and high = 26 to 32 points [29].

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Baseline Comparison

At baseline, patients reported low scores on pain intensity, anxiety symptoms, state anxiety, depression, and anger. No differences were found between patients randomized to the video exercise and the education pamphlet (Table 2).

Table 2

Table 2

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Sample Size

We conducted a single-armed pilot trial of 20 participants in our hospital and observed large effect sizes as measured with Cohen’s d (ranging from 0.87 to 1.6). Subsequent power analyses revealed that a sample size of 126 would provide excellent power (1.00) to detect large effects and adequate power (0.80) to detect effects that are considered at least medium in magnitude (Cohen’s d = 0.5).

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Statistical Analysis

Data were assessed for out-of-range values using frequency distributions and for passing all the appropriate statistical assumptions before analysis. Differences between both groups are assessed with two-sided t-tests. Analysis of covariance (ANCOVA) was used to test the null hypotheses that the intervention groups would not differ on pain intensity, state anxiety, anxiety, depression, and anger symptoms postintervention. Separate ANCOVA models were used for each outcome variable. In each ANCOVA model, intervention condition (video exercise versus educational pamphlet) was entered as the independent variable; postintervention levels of pain intensity, state anxiety, anxiety, depression, and anger were entered as dependent variables; and baseline ratings of the respective outcome variables were included as covariates. The significance level was set at a p value < 0.05 with a confidence interval of 95%.

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Results

Separate ANCOVA, controlling for respective preintervention scores, revealed that 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 (32.35 ± 0.59; control: 35.29 ± 0.59; mean difference: 2.94 [1.29-4.59]; p = 0.01); anxiety symptoms (1.49 ± 0.19; control: 2.10 ± 0.19; mean difference: 0.61 [0.08-1.14]; p = 0.024); depression (1.03 ± 0.10; control: 1.47 ± 0.11; mean difference: 0.44 [0.15-0.73]; p = 0.004); and anger (0.76 ± 0.12; control: 1.36 ± 0.12; mean difference: 0.60 [0.26-0.94]; p = 0.001) (Table 3; Fig. 2). However, the observed differences in pain intensity had < 1-point difference between the groups, which is below the MCID established in patients with chronic pain. No MCID is available for the other measures.

Table 3

Table 3

Fig. 2

Fig. 2

All patients who were enrolled completed the intervention and the pre- and postintervention measures, leading to a feasibility rate of 100%. Acceptability was medium and not different between patients receiving the mindfulness-based video exercise (mean = 20.70 ± 5.48) and controls (mean = 20.52 ± 6.42; p = 0.432).

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Discussion

Mindfulness-based interventions have been found to be useful in reducing pain and psychologic distress [12, 14, 25, 26, 43-45]. Although efficacious, such interventions are resource-intensive, lengthy, require trained providers, and may not be feasible in busy orthopaedic practices. We sought to determine whether a 60-second personalized mindfulness-based video exercise is feasible, accepted, and efficacious in reducing pain, state anxiety, anxiety symptoms, anger, and depression in patients presenting to a busy orthopaedic surgery practice.

This study should be interpreted in light of its limitations. Limitations include (1) enrollment at a major academic medical setting, which may limit generalizability; (2) inclusion of patients regardless of pain or distress level, which may have underestimated our results as a result of a floor effect; (3) there were no MCIDs established for our outcomes except pain, meaning although some differences were large, they might not be clinically significant; (4) we used an MCID of 1 point on the NRS for pain intensity, which has a lower accuracy for patients with baseline scores > 4 points; (5) postintervention measurements were taken directly after the video exercise was completed, which limits our conclusions about the durability of the intervention; (6) although we assessed how satisfied participants were with the intervention, it is not possible for us to know how engaged they were with the material during the 60 seconds of the intervention; and (7) exclusion of patients who did not have access to the Internet-based intervention, which may further limit generalization of findings. Patients who are older adults, less educated, or living in a lower income household are more likely to have no access to the Internet [34]. However, only 11 people were excluded because of these criteria and the mean age of our participants is comparable and even slightly higher than most prior mindfulness-based studies [14, 26, 44]. In addition, the average education level within our cohort, that is between high school and college, is comparable to the national average [6, 7]. This implies that this exclusion criterion might not have influenced the mean age and education level of our cohort.

This study is the first to show that a 60-second mindfulness-based intervention may be enough for individuals to experience improved pain and psychologic outcomes, relative to education alone, and is consistent with findings of previous reports showing that mindfulness-based interventions improve pain intensity and psychologic distress relative to both passive (eg, treatment as usual, waiting list) and active controls (eg, attention placebo controls) [2, 26, 27, 30, 44, 46]. Differences between the video exercise and the control were found, suggesting that a single session of 60 seconds may be sufficient to induce changes in pain and psychologic distress relative to an educational pamphlet. However, it is unclear whether these improved outcomes are meaningful to patients because no MCID is available for most measures, and the magnitude of improved pain intensity was below the 1-point MCID. A MCID of 2 points was more often used in prior studies using the NRS for pain intensity. However, our cohort consisted of a mean baseline score of < 4 points, meaning a MCID of 0.7 points is accurate to measure a difference that is perceived as “much better” by a patient. This is not surprising given the inclusion of patients with baseline scores below 1 point on pain and psychologic distress variables, which underestimated our results. Despite the most effective dose for mindfulness interventions remains unknown [26], prior research on mindfulness-based interventions suggests that the effect and skills of such intervention might be amplified, large, and durable once the intervention is repeated and practiced over a longer period of time [14, 25]. Considering the length of the intervention, a systematic review found no differences between mindfulness-based interventions ranging from 6 to 28 hours on psychologic distress [13]. The shortest session tested in this review was 1 hour and the shortest program consisted of four sessions.

The excellent feasibility and medium acceptability findings suggest that patients are amenable to 60-second mindfulness exercises delivered within an orthopaedic surgical practice. This is important particularly because patients are not expecting to receive pain and stress management interventions in orthopaedic surgical practices. The scores for acceptability were comparable for both groups, suggesting that patients remained blind to whether they received the intervention or control. Prior studies assessing the feasibility and acceptability of mindfulness-based intervention to improve outcomes on pain and psychologic distress agree with these findings and conclude that such interventions are feasible and acceptable with scores ranging from medium to high on the client satisfaction questionnaire [1, 15, 47, 48]. The length of the intervention limits participants’ fatigue, which may contribute to the 0% dropout rate, which was lower than the 88.5% to 56.6% rate that has been observed in multisession interventions [14, 25] of classic length. In a busy orthopaedic practice, only short interventions have the potential to be feasibly implemented during waiting times. In addition, we conducted a single session of our mindfulness exercise, which means a higher dropout rate might be expected if we performed followup measurements.

In conclusion, a 60-second interactive personalized mindfulness video is feasible in the orthopaedic practice, acceptable for orthopaedic upper extremity patients, and showed detectable improved levels of pain, anxiety, depression, and anger levels in patients with orthopaedic upper extremity injury when compared with an educational pamphlet. Future research should focus on the minimal effective dose (length and frequency) and durability of such self-help interventions to be clinically effective and applicable in a home-based setting or during medical appointments (such as in the waiting room). In addition, larger effects in subgroups of patients with at least levels of pain and psychologic distress that exceed the score of 1 point may be found once tested. In addition, our study adds to prior findings of online face-to-face mindfulness-based interventions by demonstrating that a brief computerized intervention is promising as a supplementary treatment for pain [17, 18, 25]. Because these interventions do not need the guidance of an experienced therapist, implementation of such interventions in an orthopaedic practice has the potential to be feasible and effective. In addition, future 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.

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