The Health Impact of Mindfulness Based Stress Reduction on Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Behavioral: Pre-operative MBSR

• Registration Number: NCT03228745
• Lead Sponsor: University of Manitoba

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-25
• Study Start: 2017-08-16
• Primary Completion: 2020-03-10
• Study Completion: 2020-10-20
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• on waitlist for first TKA

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-operative MBSR	Pre-operative MBSR	Pre-operative MBSR is a condition where individuals 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.

Primary Outcome Measures

Name	Time	Method
Number of participants undergoing total knee arthroplasty who complete the mindfulness course MBSR to determine feasibility of this intervention	Up to 18 months	Feasibility of MBSR intervention for TKA patients by determining the proportion of individuals who consent, are recruited, and complete the study.

Secondary Outcome Measures

Name	Time	Method
Cognitive function Patient- Reported Outcomes Measurements Information System (PROMIS) scales	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	Brief self-report questionnaire with questions surrounding cognitive function
Pain interference PROMIS scale	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	Brief self-report questionnaire with questions surrounding pain interference
Anxiety PROMIS scale	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	Brief self-report questionnaire with questions surrounding anxiety
Fatigue PROMIS scale	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	Brief self-report questionnaire with questions surrounding fatigue
Depression PROMIS scale	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	Brief self-report questionnaire with questions surrounding anxiety
Pain behaviour PROMIS scale	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	Brief self-report questionnaire with questions surrounding pain behaviour
Sleep disturbance PROMIS scale	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	Brief self-report questionnaire with questions surrounding sleep disturbance
Psychosocial Illness Impact PROMIS scale	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	Brief self-report questionnaire with questions surrounding psychosocial illness impact
Pain Catastrophizing scale	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	Brief self-report questionnaire surrounding pain catastrophizing
Global health PROMIS scale	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	Brief self-report questionnaire with questions surrounding global health
The benefit from mindfulness intervention assessed by the Five Facet Mindfulness Questionnaire	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	Use a brief self-report questionnaire to determine if the participant's level of mindfulness increased as a result of the study

Trial Locations

Locations (1)

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada