The Effect of Mindfulness Training Before Primary Total Joint Arthroplasty on Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Pittsburg Sleep Quality Index score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
No Treatment
Patient will receive no mindfulness meditation training.
Mindfulness at Pre-Op
Patient will receive a one time training at their pre-operative appointment.
干预措施: Mindfulness Meditation Training (Behavioral)
Multiple Mindfulness Meditation
Mindfulness Video Training at Pre-Op, 1 Day Prior to surgery, 3 day's Post OP and 2 Weeks Post OP.
干预措施: Mindfulness Meditation Training (Behavioral)
结局指标
主要结局
Pittsburg Sleep Quality Index score
时间窗: 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.
次要结局
- Epworth Sleepiness Scale(Change from Pre-Op to 2, 6 and 12 weeks post op.)
- Knee Injury and Osteoarthritis Outcome Scores JR(Change from Pre-Op to 2, 6 and 12 weeks post op.)
- Visual Analog Score(Change from Pre-Op to 2, 6 and 12 weeks post op.)
- Knee Society Score (KSS)(Change from Pre-Op to 6 Weeks post op.)
- Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD)(Change from Pre-Op to 2, 6 and 12 weeks post op.)
研究者
Jason Jennings
Orthopedic Surgeon
Colorado Joint Replacement