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

NCT03228745 | Completed

• 1 other identifier: H2017:299
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Keywords

mindfulness based stress reduction; total knee arthroplasty; pre-operative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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.

Behavioral: Pre-operative MBSR

treatment-as-usual (TAU)

NO INTERVENTION

The individuals in the TAU group will receive their treatment as usual.

Interventions

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.

Also known as: mindfulness based stress reduction

pre-operative MBSR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• on waitlist for first TKA

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0Z2, Canada

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., Assistant Professor, Staff Psychologist

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 25, 2017
• Study Start: August 16, 2017
• Primary Completion: March 10, 2020
• Study Completion: October 20, 2020
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)