NCT05295004

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: Colorado Joint Replacement · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disturbance
• Arthropathy

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Meditation Training	Patient will watch a 10 minute video on how to use mindfulness meditation to help with sleep after a total joint replacement procedure.

Timeline

• Start date: 2022-03-15
• Primary completion: 2024-03-15
• Completion: 2024-07-31
• First posted: 2022-03-24
• Last updated: 2023-07-10

Locations

1 site across 1 country: United States