Clinical trial NCT03228745: The Health Impact of Mindfulness Based Stress Reduction on Total Knee Arthroplasty
Official title: The Health Impact of Mindfulness Based Stress Reduction on Total Knee Arthroplasty: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: mindfulness based stress reduction
total knee arthroplasty
pre-operative
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite surgical success of total knee arthroplasty (TKA), reports of dissatisfaction and poor outcomes including increased pain, reduced function for daily activities, and compromised psychological health are common. Interventions to improve TKA outcomes are primarily education-focused, however there is little support for efficacy. Evidence suggests that mindfulness based stress reduction (MBSR) is effective for improving both physical and mental health, which are factors implicated in negative post-operative TKA outcomes. The efficacy of this empirically supported intervention on TKA outcomes has not been assessed. The proposed pilot study will conduct a randomized controlled trial to evaluate the feasibility and efficacy of pre-surgical MBSR on post-surgical outcomes. Post-operative pain (severity and catastrophizing), functioning (interference and illness impact), quality of life, emotional distress (anxiety and depression) and sleep will be assessed in pre-surgical MBSR and compared to treatment as usual. This pilot will provide an opportunity for TKA patients to receive an intervention that may improve outcomes. Further, it will provide insight into the relationship between pre-surgical MBSR and post-operative TKA outcomes, which will assist in the development of MBSR adaptations to less time intensive, and potentially more accessible, future offerings.

Detailed description: 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 pre-operative MBSR group (30 participants, divided into two MBSR groups), and the treatment-as-usual (TAU;15 participants). The individuals in the pre-operative MBSR group will receive a pre-operative 8-week community-based MBSR course taught by a certified instructor, 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, all patients will receive another set of short self-reported questionnaires. All 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.

Eligibility criteria: Inclusion Criteria:

* on waitlist for first TKA

Exclusion Criteria:

* on waitlist for revision TKA
* taken a mindfulness course in the past 2 years
* not able to read or understand English

Primary outcomes:
measure: Number of participants undergoing total knee arthroplasty who complete the mindfulness course MBSR to determine feasibility of this intervention
timeFrame: Up to 18 months
Secondary outcomes:
measure: Cognitive function Patient- Reported Outcomes Measurements Information System (PROMIS) scales
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
measure: Fatigue PROMIS scale
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
measure: Pain interference PROMIS scale
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
measure: Pain behaviour PROMIS scale
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
measure: Sleep disturbance PROMIS scale
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
measure: Psychosocial Illness Impact PROMIS scale
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
measure: Global health PROMIS scale
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
measure: Anxiety PROMIS scale
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
measure: Depression PROMIS scale
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
measure: Pain Catastrophizing scale
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
measure: The benefit from mindfulness intervention assessed by the Five Facet Mindfulness Questionnaire
timeFrame: Change in score from two weeks prior to surgery, week 6-8 post op, 6 month post-op, and 1 year post-op. If in the pre-operative MBSR group, also will complete these measures at the orientation of the MBSR program
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Renee El-Gabalawy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Jennifer Kornelsen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Eric Bohm, MD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Corey Mackenzie, PhD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Heather Macdonald, MD
role: STUDY_DIRECTOR
affiliation: University of Regina
name: Gordon Asmundson, PhD
role: STUDY_DIRECTOR
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