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Clinical Trials/NCT05295004
NCT05295004
Recruiting
N/A

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

Colorado Joint Replacement1 site in 1 country282 target enrollmentMarch 15, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sleep Disturbance
Sponsor
Colorado Joint Replacement
Enrollment
282
Locations
1
Primary Endpoint
Pittsburg Sleep Quality Index score
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 15, 2022
End Date
July 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jason Jennings

Orthopedic Surgeon

Colorado Joint Replacement

Eligibility Criteria

Inclusion Criteria

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

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 4 weeks prior to scheduled surgery will also be excluded, as the MM intervention would not be possible to administer.

Outcomes

Primary Outcomes

Pittsburg Sleep Quality Index score

Time Frame: Change from Pre-Op to 2, 6 and 12 weeks post op.

Improvement in Pittsburg Sleep Quality Index (PSQI) score, Scale is 0 to 21, higher score is worse outcome.

Secondary Outcomes

  • Knee Injury and Osteoarthritis Outcome Scores JR(Change from Pre-Op to 2, 6 and 12 weeks post op.)
  • Epworth Sleepiness Scale(Change from Pre-Op to 2, 6 and 12 weeks post op.)
  • Visual Analog Score(Change from Pre-Op to 2, 6 and 12 weeks post op.)
  • Knee Society Score (KSS)(Change from Pre-Op to 6 Weeks post op.)
  • Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD)(Change from Pre-Op to 2, 6 and 12 weeks post op.)

Study Sites (1)

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