An interventional study of Mindfulness Meditation Training in Sleep Disturbance and Arthropathy, sponsored by Colorado Joint Replacement. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Colorado Joint Replacement · Not applicable, Interventional, and Treatment
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.
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's planned enrollment of 282 is above the median of 60 across 470 interventional studies indexed under Joint Diseases.
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Exclusion Criteria:
Patient will receive no mindfulness meditation training.
Patient will receive a one time training at their pre-operative appointment.
Behavioral: Mindfulness Meditation Training
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
Patient will watch a 10 minute video on how to use mindfulness meditation to help with sleep after a total joint replacement procedure.
Pittsburg Sleep Quality Index score
Improvement in Pittsburg Sleep Quality Index (PSQI) score, Scale is 0 to 21, higher score is worse outcome.
Time frame: Change from Pre-Op to 2, 6 and 12 weeks post op.
Visual Analog Score
Improvement in Visual Analog Score (VAS), Scale is 1 to 10, higher score is worse outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Pre-Op to 2, 6 and 12 weeks post op.
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