The Effect of Mindfulness Training Before Primary Total Joint Arthroplasty on Sleep Quality
- Conditions
- ArthropathySleep Disturbance
- Interventions
- Behavioral: Mindfulness Meditation Training
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 282
- 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.
- 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
- Arm && Interventions
Group Intervention Description Mindfulness at Pre-Op Mindfulness Meditation Training Patient will receive a one time training at their pre-operative appointment. Multiple Mindfulness Meditation Mindfulness Meditation Training Mindfulness Video Training at Pre-Op, 1 Day Prior to surgery, 3 day's Post OP and 2 Weeks Post OP.
- 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