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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-operative MBSR | Experimental | 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. |
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| treatment-as-usual (TAU) | No Intervention | The individuals in the TAU group will receive their treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative MBSR | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants undergoing total knee arthroplasty who complete the mindfulness course MBSR to determine feasibility of this intervention | Feasibility of MBSR intervention for TKA patients by determining the proportion of individuals who consent, are recruited, and complete the study. | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function Patient- Reported Outcomes Measurements Information System (PROMIS) scales | Brief self-report questionnaire with questions surrounding cognitive function | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renee El-Gabalawy, PhD | University of Manitoba | Principal Investigator |
| Jennifer Kornelsen, PhD | University of Manitoba | Principal Investigator |
| Eric Bohm, MD | University of Manitoba | Study Director |
| Corey Mackenzie, PhD | University of Manitoba | Study Director |
| Heather Macdonald, MD | University of Manitoba | Study Director |
| Gordon Asmundson, PhD | University of Regina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Winnipeg | Manitoba | R3E 0Z2 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2017 | Jul 10, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2017 | Jul 10, 2017 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2017 | Jul 10, 2017 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Fatigue PROMIS scale | Brief self-report questionnaire with questions surrounding fatigue | 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 |
| Pain interference PROMIS scale | Brief self-report questionnaire with questions surrounding pain interference | 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 |
| Pain behaviour PROMIS scale | Brief self-report questionnaire with questions surrounding pain behaviour | 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 |
| Sleep disturbance PROMIS scale | Brief self-report questionnaire with questions surrounding sleep disturbance | 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 |
| Psychosocial Illness Impact PROMIS scale | Brief self-report questionnaire with questions surrounding psychosocial illness impact | 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 |
| Global health PROMIS scale | Brief self-report questionnaire with questions surrounding global health | 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 |
| Anxiety PROMIS scale | Brief self-report questionnaire with questions surrounding anxiety | 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 |
| Depression PROMIS scale | Brief self-report questionnaire with questions surrounding anxiety | 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 |
| Pain Catastrophizing scale | Brief self-report questionnaire surrounding pain catastrophizing | 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 |
| The benefit from mindfulness intervention assessed by the Five Facet Mindfulness Questionnaire | Use a brief self-report questionnaire to determine if the participant's level of mindfulness increased as a result of the study | 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 |
| D004191 |
| Behavioral Disciplines and Activities |