The Health Impact of Mindfulness Based Stress Reduction on Total Knee Arthroplasty: A Pilot Study
Phase: NA
Conditions: Total Knee Arthroplasty
Sponsor: University of Manitoba

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El-Gabalawy & Kornelsen – MBSR TKA 
HREB Protocol  
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RESEARCH PROTOCOL 
 
The “What is a Protocol?” file on the HREB ethics website requested that 
applicants provide information about both the scientific and ethical aspects of their 
proposal.  We will therefore divide this protocol description into those two sections. 
 
1. Scientific Elements 
 
(a) Background Research 
 
In 2010 - 2011, more than 762,000 total knee arthroplasty (TKA) surgical procedures 
were performed across Canada (1). This number is expected to increase dramatically in 
the coming years with the growing older adult population and with the recently quantified 
TKA projections for younger patients (2). The growth of this procedure has resulted in 
increasing reports of dissatisfaction and poor outcomes such as increased pain, unmet 
expectations, reduced daily functioning (3), and compromised psychological health (4). 
Although suboptimal outcomes are not unusual in surgical procedures, there is a 
discrepancy in the proportion of poor outcomes associated with TKA compared to other 
arthroplasties. For example, 18-20% of patients following TKA report dissatisfaction (3, 
5) compared to only 7% following a total hip arthroplasty (6). In response to these 
discrepant findings, there have been a significant number of studies that have identified 
psychological and psychosocial factors that are implicated in poor outcomes of TKA, 
even when controlling for medical factors such as surgical technique (7). This is not 
surprising given that more than 50% of adults undergoing TKA suffer from osteoarthritis, 
which has high comorbidity rates with mental disorders (8). Although psychological 
factors have been identified as contributing to poor outcomes, it is not clear whether an 
evidence-based psychological intervention can positively impact post-TKA sequelae. 
This study aims to pilot the effectiveness of an empirically supported intervention, 
mindfulness based stress reduction (MBSR), on post-TKA outcomes using a superiority 
randomized controlled trial (RCT) design. 
 
TKA Outcomes. It is common for patients to have a successful TKA surgery but report 
dissatisfaction post-operatively (9), which has been largely attributed to post-operative 
pain (10) and restrictions in functioning and engaging in daily activities (3). Pain 
catastrophizing, defined as a tendency to magnify the threat of pain, is associated with the 
intensity of post-operative pain (11). Further, pre-surgical pain catastrophizing has also 
been linked to post-surgical pain and function (12). In some cases, the symptoms of pain 
following TKA surgery may become prolonged and debilitating, to the point where 
patients develop a chronic pain condition (13).  
Predictors of Outcomes. It is essential to identify predictors of poor outcomes of 
TKA for targeted prevention initiatives. Female patients (14) and specifically those from 
low-income households (14) are at increased risk of reporting dissatisfaction following 
TKA. Dysfunctional coping style (15, 16) and lower internal locus of control (16) have 
been associated with poor TKA outcomes, and preoperative patient expectations are 
linked to dissatisfaction following TKA (5, 15). A growing body of research has 
demonstrated that psychological factors such as pain catastrophizing (17, 18), depression 

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(18), and anxiety (19) are significant predictors of persistent pain following TKA. 
 
Interventions to Improve TKA Outcomes. Most of the targeted TKA pre-operative 
interventions to date have been education-focused (20, 21). A systematic review revealed 
that although pre-operative education can reduce anxiety, there is little evidence that it 
improves post-operative outcomes (26). Additional interventions, such as pre-operative 
exercises (22) or resistance training (23) exist, but the literature is mixed on whether they 
improve outcomes of TKA such as pain or physical functioning (24, 25). Although a 
large and growing number of studies have identified psychological and psychosocial 
factors as indicators of poor outcomes, research has not yet examined interventions 
targeting these risk factors directly. 
 
Mindfulness Based Stress Reduction. In 2008, Drs. Ludwig and Kabat-Zinn published an 
editorial in JAMA describing the benefits of mindfulness (i.e., purposeful attention to the 
present with non-judgmental acceptance) in medicine and the growing body of evidence 
to support positive physical, mental, and psychosocial outcomes following mindfulness 
interventions. MBSR is the most widely used empirically-supported intervention that 
employs mindfulness techniques to address health holistically (27). A MBSR program 
typically consists of 8 weekly 2.5 hour sessions, home practice (typically 45 minutes per 
day, 6 days per week), and one day retreat. During the program, participants engage in a 
number of mindfulness practices (e.g., body scan, mindful movement, meditation) and 
discussions of their experiences, with the aim enhancing awareness to moment-to-
moment experiences in a non-judging and accepting manner. 
Health Outcomes. The growing body of literature is demonstrating the positive 
effects of MBSR on a variety of health outcomes (28). For example, a comprehensive 
systematic review that examined 115 randomized controlled trials found that, compared 
to wait list controls, MBSR significantly improved depression, anxiety, stress, quality of 
life, and physical functioning (28). With respect to pain-related outcomes, MBSR has 
been found to significantly reduce pain intensity and improve health-related quality of 
life among patients with chronic pain conditions, with the largest effect sizes 
demonstrated among those with arthritis (29), who comprise the largest proportion of 
TKA surgeries. Similar improvements in physical symptoms such as pain intensity, 
fatigue, and quality of life were demonstrated following MBSR among patients with 
chronic headaches (30). MBSR is also associated with reductions in pain catastrophizing, 
which is highly implicated in TKA, in chronic back pain patients compared to usual care 
or a cognitive-behavioural therapy group (31). Going beyond chronic pain conditions, 
MBSR has commonly been used as a weight-management strategy (32). According to a 
recent review, mindfulness interventions result in improvements in binge eating and 
dietary intake (34). This is of interest as obesity has been identified as a complicating 
factor in TKA influencing post-operative health outcomes (35), length of stay, and higher 
medical costs (36). 
Preliminary Surgical-Related Outcomes. Despite this compelling evidence, 
there is little research examining MBSR in surgical contexts. One preliminary study 
investigating MBSR postoperatively following a spontaneous subarachnoid hemorrhage 
surgery found it resulted in significant decreases in ratings of depression and physical 

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stress, suggesting it was successful in both reducing psychological symptoms and 
improving homeostasis control mechanisms of the autonomic nervous system (37). 
 
 
(b) General Overview of the Research Plan 
 
The current research will consist of a pre-surgical MBSR course compared to a 
treatment-as-usual condition to evaluate post-surgical outcomes, including post-operative 
pain (severity and catastrophizing), improved physical functioning (interference and 
illness impact), post-surgery complications, and psychological factors including enhanced 
quality of life, reduced emotional distress (anxiety and depressive), enhanced cognitive 
skills, and improved sleep. The data will reveal if MSBR is feasible in a TKA population 
and determine if there are post-surgical benefits, as compared to the treatment as usual 
(TAU) group. 
 
(c) Objectives, Research Design, and Hypotheses 
 
Objective: The primary objectives are (a) to determine if an 8-week pre-operative MBSR 
program is feasible in a TKA population, and (b) to determine if this program results in 
reductions in post-operative pain (pain behavior, pain catastrophizing), improved 
physical functioning (pain interference, psychosocial illness impact), enhanced quality of 
life (global health), reduced emotional distress (anxiety and depression), enhanced 
cognitive skills (Cognitive Concerns), and improved sleep (fatigue, sleep disturbance) 
compared to TAU. 
 
Research Design: Forty-five participants on the waitlist for a TKA will be recruited from 
Concordia Hospital Hip and Knee Institute – a facility that performs 800 TKA’s per year. 
Participants will be divided into two groups: the MBSR group prior to surgery (30 
participants, divided into two MBSR groups), and the TAU (15 participants; MBSR after 
surgery). The individuals in the MBSR group will receive a pre-operative 8-week 
community-based MBSR course, which includes group classes lasting 2.5 hours a week, 
45-minutes of home practice 6 days per week, a 1-hour orientation session at the 
beginning, and a full-day silent retreat at the end. During the orientation, participants will 
complete the study measures for this study. Two weeks prior to the surgery at the pre-
anesthesia clinic, patients will receive another short self-reported questionnaire between 
the MBSR intervention and TAU groups. Patients will subsequently receive post-
operative questionnaires at the following regularly scheduled post-operative 
appointments: 6-8 weeks after surgery, and at 6 month and 1 year follow-ups. Clinic 
personnel, who are blinded to assignment, will administer these measures with all other 
regularly distributed clinical measures. Clinic personnel will also review the chart to 
inform researchers as to what physical condition contributed to the need for a TKA. The 
TAU group will have the opportunity to enroll in an MBSR course following the 
completion of the study (after approximately 1 year), at no cost.  
 
Hypotheses: We predict that pre-operative MBSR will improve post-surgical outcomes 
including reductions in post-operative pain (pain behavior, pain catastrophizing), 

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improved physical functioning (pain interference, psychosocial illness impact), enhanced 
quality of life (global health), reduced emotional distress (anxiety and depression), 
enhanced cognitive skills (Cognitive Concerns), and improved sleep (fatigue, sleep 
disturbance) compared to TAU group. 
 
MBSR is an empirically-supported intervention that has been used to examine 
various health outcomes and psychological factors in both health conditions (e.g., chronic 
pain; 29, anxiety and depression; 28, and binge and emotional eating; 32) and more 
recently, surgical populations (spontaneous subarachnoid hemorrhage surgery; 37). We 
are therefore confident that MBSR will improve the psychological factors and the 
physical health factors we described above. 
 
 
(d) The Selection of Participants / Sample Size Calculations 
 
TKA patients will be recruited from the TKA waitlist at Concordia Hospital Hip and 
Knee Institute– a facility that performs 800 TKA’s per year. A Concordia Hospital Hip 
and Knee Institute staff member or a psychology graduate student on the project will 
contact all participants, ensuring the inclusion/exclusion criteria are met. Participants will 
be ensured that their participation is completely voluntary, and will be reminded that 
assignment to treatment conditions is completely random; therefore, participants will not 
feel obligated to participate, but will know receiving MBSR before their surgery is not 
guaranteed. 
The sample size was estimated based on G*Power statistical software using a 2:1 
approach with a large effect size (Cohen’s d = 0.8). We will recruit 30 patients for the 
intervention where they will be divided in 2 groups that will consecutively run. The third 
TAU group will include 15 patients. This will yield 45 total participants. A 2:1 approach 
is used to assess within person change pre- and post-surgically given the pilot nature of 
the study and to protect against up to 20% attrition in the intervention group.  
 
(e) Behavioural and Diagnostic Data 
 
A variety of data will be collected during the initial telephone screening to ensure that 
participants meet our inclusion criteria. A phone screen template will be used to 
standardize the recruitment process. Because phone screening is conversational, the study 
description on the phone screen form has phrases that are italicized, and these are the key 
points that the phone screen interviewer will convey. We will be collecting information 
about age, sex, and language that they can read and understand. We will ask whether they 
are currently on the waitlist for a TKA, and whether they surgery they are waiting for is 
their first surgery (i.e., not a revision surgery). We will also be asking whether 
participants have ever been enrolled in an MBSR program or any other mindfulness 
course before, and if so, when it took place. All of these questions are very important in 
deciding whether participants are eligible for participating in this study.  
After participants are screened for eligibility and provide verbal consent, they will be 
mailed out packages explaining MBSR in more detail, include two copies of consent 
forms, and a return envelope. After randomization, those in the MBSR group will 
complete study measures prior to their pre-operative MBSR course (at an orientation 

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session). These measures include: Patient- Reported Outcomes Measurements 
Information System (PROMIS) scales (Cognitive function, Fatigue, Pain Interference, 
Pain Behavior, Sleep Disturbance, Psychosocial Illness Impact, Global Health, Anxiety, 
and Depression scales (see: www.healthmeasures.net for information pertaining to NIH 
PROMIS initiative), a demographics form, the 13- item Pain Catastrophizing Scale (38), 
and the Five Facet Mindfulness Questionnaire (41). Two weeks prior to the surgery at the 
pre-anesthesia clinic, patients will receive another short self-reported questionnaire, as 
well as a questionnaire asking about participation in any other prehabilitation courses 
offered through the Hip and Knee Institute or any other centre.  In PAC, clinic personnel 
will review the chart to inform researchers as to what physical condition contributed to 
the need for a TKA. Patients will subsequently receive post-operative questionnaires at 
the following regularly scheduled post-operative appointments: week 6-8, 6 month, and 1 
year. Clinic personnel, who are blinded to assignment, will administer these measures 
with all other regularly distributed clinical measures, and they can complete while 
waiting for their appointment. 
 
(f) Data Analysis 
 
We will be looking at changes in outcomes from before to after the MBSR 
intervention in (a) the MBSR compared to TAU participants, and (b) within the MBSR 
participants. We will focus on within-persons mean differences using paired samples t-
tests within the intervention group. To determine the impact of MBSR on the 
postoperative TKA outcomes, we will conduct multivariate analyses of variance of 
conceptually linked dependent variables (i.e. pain variables, mental health variables) with 
significant results followed up by Tukey post-hoc tests. 
 
(g) Timeline 
 
We hope to begin recruitment after we have obtained ethics approval from both the 
University of Manitoba and Concordia Hospital Hip and Knee Institute in August 2017. 
We hope to run the MBSR courses in Fall 2017, run by a teacher (Bernice Parent) with 
extensive MBSR and yoga training. We anticipate the total duration of this study will 
August 2017 to August 2019. We will renew our ethics protocol annually, as per HREB 
requirements. 
 
(h) Definition of Adverse Events 
 
The adverse events should be limited to a reaction to the MBSR course. Participants 
will be fully informed about MBSR, and what participation in the course will include. In 
the unlikely event that a participant feels extreme discomfort in a meditation position 
(e.g., their knee hurts too much), the MBSR instructor has been trained to manage these 
situations. If additional support is warranted, appropriate resources will be implemented 
as described in the ethics form. 
 
(i) Budget 
Professional Assistance:  

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MBSR instruction: 
$18,500 in fee payment to qualified MBSR instructor.   
[(45 participants x $400/participant) +$500 orientation fee = $18,500]   
A certified, trained MBSR instructor is required to deliver the MBSR course. The course 
will be offered to the TKA patients at no cost to themselves, so as to maximize 
enrollment. No honorariums will be provided to the participants, as the waiver of the 
MBSR fee is already significant. The MBSR instructor's time, her securing of 
accommodations in which to hold the sessions, and providing all necessary resources 
(i.e., workbooks) are included in the fee of $400/participant. The instructor's time for 
conducting the 1 hour orientation meetings for all 3 groups is $500. 
See letter from MBSR instructor for quote (appended to this application).  
 
TKA clinic assistance: 
[($60/hr x 143 hrs) + $150) = $8,730] 
 
$8,730 is required for the assistance of the TKA clinic staff.  As TKA patients will be 
recruited from the clinic, access to standard clinic measures will be required, and 
administration of the additional study-specific measures will be performed by clinic staff 
at the patient's scheduled appointments, compensation to clinic staff is required. Clinic 
staff have identified the following time commitments: 
1.       Pulling waitlist patient info (contact #’s & expected date of sx): 4 hrs 
2.       Query to pull pre-op Oxford (and other) data for 30 pts: 4 hrs 
3.       Administer, fill & send post-op questionnaire packages at 6 wks, 6 mo, 12 mo: ½ 
hr per visit = 45 hrs 
4.       Query to pull all post-op Oxford, Satisfaction data for 30 pts: 30 hrs 
5.       Calling and recruiting of patients (mail-out consent & pre-op packages) ½ hr per 
patient (say 25% rate of enrollment) + mailing costs (~$5 per, incl. return shipping) = 60 
hrs + $150 mailing 
The typical research staff rate is $60/hr, covering wages and a portion of overhead, for a 
total of $8,580, plus $150 for mailing.   
 
All materials and supplies are currently available and do not require additional budgeting.  
 
Anesthesia residents and graduate student involvement are covered by respective 
departmental obligations and do not require additional budgeting.  
 
NOTE: This budget exceeds the limit of $25,000 available from the UCRP; however, 
Drs. El-Gabalawy and Kornelsen will cover the $2,230 of above-budget costs from their 
start-up funding. 
 
2. Ethical Elements 
 
(a) Potential Benefits to Participants and Others 
 

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Ours will be the first study to test pre-surgical MBSR on post-surgical TKA 
outcomes. TKA patients are a group of patients growing exponentially and are known to 
have poor health outcomes. MBSR is a relatively risk-free, empirically supported 
intervention that has potential to alleviate or lessen these outcomes. Therefore, it should 
be of interest to TKA patients, especially considering the benefits can be applied to all 
aspects of their lives, not just in regard to their upcoming surgery. This study may also 
provide insight on the feasibility of such an intervention to this surgical population. It 
may allow further research into an adapted version of the MBSR, which could enhance 
accessibility and service delivery. It may also have broader health and economic 
implications. 
 
(b) Potential Harms to Participants and Others 
 
There is a possibility that some participants might find a particular meditation posture 
(e.g., sitting) uncomfortable; however, appropriate modifications will be suggested by the 
MBSR instructor. Patients may experience temporary discomfort from answering 
questions related to emotional health; however, resources will be provided if warranted. 
In exceptional circumstances staff Psychologist, Dr. Renée El-Gabalawy (co-PI), will be 
contacted by research personnel.  
 
(c) Alternative Treatments or Procedures 
 
The participants randomly assigned to the MBSR group will receive MBSR prior to 
surgery and the participants who are assigned to treatment as usual will receive MBSR 1 
year after surgery.  
 
(d) Minimization of Potential Harms 
 
Concerns regarding MBSR will be minimized through the prescreening and through 
the forms that thoroughly explain MBSR. All participants who consent will receive these 
documents and be reminded that if they have any concerns about participation, to not 
hesitate to ask. 
Privacy/confidentiality concerns will be minimized by assigning all participants an 
alpha-numeric code that will be linked to their data.  A file linking the participant’s name 
to his or her code will be kept on a password-protected computer in a secure, locked 
laboratory room. 
 
(e) The Process for Seeking Consent 
 
All participants will first provide verbal consent during the prescreening period and 
completed written consent prior to participating in this study; the consent forms were 
included in this ethics application and will be mailed out to participants along with a 
return envelope.  
 
 
 
 

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