The Effect of Mindfulness Training Before Primary Total Joint Arthroplasty on Sleep Quality

Last updated: July 7, 2023
Sponsor: Colorado Joint Replacement
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Restless Leg Syndrome

Narcolepsy

Treatment

Mindfulness Meditation Training

Clinical Study ID

NCT05295004
1845025
  • Ages 18-90
  • All Genders

Study Summary

The primary purpose of this study is the determine whether a 15 minute Mindfulness Meditation (MM) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (TJA) results in any improvement in Pittsburg Sleep Quality Index (PSQI) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients undergoing primary unilateral total joint arthroplasty at Colorado JointReplacement
  • Between the ages of 18 and 90 years old will be included in the study.

Exclusion

Exclusion Criteria:

  • Simultaneous total joint arthroplasty
  • Uni-compartmental knee arthroplasty
  • Revision surgery for infection, fracture or other indication.
  • History of Drug or Alcohol Abuse
  • Patients who are unable to present at a standard pre-operative appointment within 4weeks prior to scheduled surgery will also be excluded, as the MM intervention wouldnot be possible to administer.

Study Design

Total Participants: 282
Treatment Group(s): 1
Primary Treatment: Mindfulness Meditation Training
Phase:
Study Start date:
March 15, 2022
Estimated Completion Date:
July 31, 2024

Study Description

The primary purpose of this study is the determine whether a 15 minute Mindfulness Meditation (MM) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (TJA) results in any improvement in Pittsburg Sleep Quality Index (PSQI) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively. We hypothesize that patients in the MM cohort will have lower PSQI scores, indicating higher sleep quality, at both post-operative time points. Secondary aims include characterizing differences between cohorts in Visual Analog Scale (VAS) for pain, Epworth Sleepiness Scale (ESS) scores, Patient Reported Outcome Measurement Information System - Sleep Disturbance - Short Form, and Knee Injury and Osteoarthritis Outcome Scores (KOOS) at 2, 6 and 12 weeks following TJA.

Connect with a study center

  • Colorado Joint Replacement

    Denver, Colorado 80210
    United States

    Active - Recruiting

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