The Effect of Utilizing Mindfulness Perioperatively on Pain, Opioid Consumption, and Functional Outcomes in Patients With Depression and Anxiety Undergoing Total Knee Arthroplasty: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Participant satisfaction #1
研究概览
简要总结
This study will be a prospective randomized controlled trial evaluating the effectiveness of using Headspace before and after undergoing total knee replacement surgery. The purpose of this study will be to determine whether using Headspace will help to improve functional outcome scores, decrease pain, and decrease opioid medication use after total knee replacement in patients with depression and/or anxiety. Headspace is a smartphone-based application that guides individuals through various mindfulness sessions and has been shown to reduce symptoms of depression, anxiety, and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing unilateral primary TKA
- •Patients with MDD who take medication for MDD and/or Patients with GAD who take medication for GAD
- •Patients with MDD and/or Patients with GAD who are being treated for those conditions with psychotherapy by a psychologist or psychiatrist
- •Patients with an SF-12 Mental Health Score less than 45.6
- •Owning a smartphone (Apple or Android) to be able to download the mindfulness application
排除标准
- •Patients undergoing bilateral TKA
- •Patients undergoing revision TKA
- •Patients with mental health conditions other than MDD and/or GAD
- •Patients currently utilizing a mindfulness application
结局指标
主要结局
Participant satisfaction #1
时间窗: 6 weeks
Participant satisfaction will be measured using the 12-Item Short Form (SF-12) questionnaire
Postoperative pain
时间窗: 6 weeks
postoperative pain will be measured using the Visual Analog Score (VAS)
Participant mental health
时间窗: 6 weeks
mental health will be tracked using the Headspace application after surgery
Participant satisfaction #2
时间窗: 6 weeks
Participant satisfaction will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) questionnaire
次要结局
未报告次要终点