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

NCT03228745 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-05-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Renee El-Gabalawy, PhD · University of Manitoba

  • Jennifer Kornelsen, PhD · University of Manitoba

  • Eric Bohm, MD · University of Manitoba

  • Corey Mackenzie, PhD · University of Manitoba

  • Heather Macdonald, MD · University of Manitoba

  • Gordon Asmundson, PhD · University of Regina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2020-03-10
Completion
2020-10-20

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03228745 on ClinicalTrials.gov