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

Total Knee Arthroplasty Clinical Trial

Official title:

The Health Impact of Mindfulness Based Stress Reduction on Total Knee Arthroplasty: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228745
• Other study ID #: H2017:299
• Status: Completed
• Phase: N/A
• Start date: August 16, 2017
• Est. completion date: October 20, 2020

Study information

• Verified date: May 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 20, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Behavioral:
• Pre-operative MBSR
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.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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