Sleep Disturbance, Arthropathy
Conditions
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.
Interventions
BEHAVIORALMindfulness 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.
Sponsors
Colorado Joint Replacement
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactRoseann Johnson, BS, CCRP
Outcome results
None listed