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Completed

NCT Number: NCT03228745

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

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manitoba

Winnipeg, Manitoba, R3E 0Z2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: mindfulness based stress reduction

Primary outcomes

  1. Number of participants undergoing total knee arthroplasty who complete the mindfulness course MBSR to determine feasibility of this intervention

    Time frame: 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 outcomes

  1. Cognitive function Patient- Reported Outcomes Measurements Information System (PROMIS) scales

    Time frame: 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

  2. Fatigue PROMIS scale

    Time frame: 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

  3. Pain interference PROMIS scale

    Time frame: 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

  4. Pain behaviour PROMIS scale

    Time frame: 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

  5. Sleep disturbance PROMIS scale

    Time frame: 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

  6. Psychosocial Illness Impact PROMIS scale

    Time frame: 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

  7. Global health PROMIS scale

    Time frame: 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

  8. Anxiety PROMIS scale

    Time frame: 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

  9. Depression PROMIS scale

    Time frame: 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

  10. Pain Catastrophizing scale

    Time frame: 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

  11. The benefit from mindfulness intervention assessed by the Five Facet Mindfulness Questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 25, 2017
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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