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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Disturbance, Arthropathy

Intervention / Treatment
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* Behavioral: Mindfulness Meditation Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomize à Arm 1 (No Treatment), Arm 2 (Mindfulness Video @ Pre-Op), Arm 3 (Mindfulness Video @ Pre-Op, 1 Day Prior to surgery, 3 day's Post OP, 2 Weeks Post OP)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Treatment<br>Patient will receive no mindfulness meditation training. | |
| Experimental: Mindfulness at Pre-Op<br>Patient will receive a one time training at their pre-operative appointment. | Behavioral: Mindfulness Meditation Training<br>* Patient will watch a 10 minute video on how to use mindfulness meditation to help with sleep after a total joint replacement procedure.<br>|
| Experimental: Multiple Mindfulness Meditation<br>Mindfulness Video Training at Pre-Op, 1 Day Prior to surgery, 3 day's Post OP and 2 Weeks Post OP. | Behavioral: Mindfulness Meditation Training<br>* Patient will watch a 10 minute video on how to use mindfulness meditation to help with sleep after a total joint replacement procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburg Sleep Quality Index score | Improvement in Pittsburg Sleep Quality Index (PSQI) score, Scale is 0 to 21, higher score is worse outcome. | Change from Pre-Op to 2, 6 and 12 weeks post op. | 

Secondary Outcome Measures

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