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

Not Applicable

Recruiting

• Conditions: Arthropathy; Sleep Disturbance

• Registration Number: NCT05295004
• Lead Sponsor: Colorado Joint Replacement

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.

Study Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10
• Primary Completion: 2024-03-15
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 282

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pittsburg Sleep Quality Index score	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 Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Scores JR	Change from Pre-Op to 2, 6 and 12 weeks post op.	Improvement in Knee Injury and Osteoarthritis Outcome Scores JR (KOOS JR), Scale is 1 to 100, lower score is worse outcome
Epworth Sleepiness Scale	Change from Pre-Op to 2, 6 and 12 weeks post op.	Improvement in Epworth Sleepiness Scale (ESS), Scale is 0 to 24, higher score is worse outcome
Visual Analog Score	Change from Pre-Op to 2, 6 and 12 weeks post op.	Improvement in Visual Analog Score (VAS), Scale is 1 to 10, higher score is worse outcome
Knee Society Score (KSS)	Change from Pre-Op to 6 Weeks post op.	Improvement in Knee Society Score (KSS), Scale is 0 to 100, lower score is worse outcome
Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD)	Change from Pre-Op to 2, 6 and 12 weeks post op.	Improvement in Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD), Scale is 8 to 40, higher score is worse outcome

Trial Locations

Locations (1)

Colorado Joint Replacement; 🇺🇸 Denver, Colorado, United States