Brief Nurse-led Mindfulness Based Intervention Among Patients Scheduled for Knee and Hip Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity Numeric Rating Scale
研究概览
简要总结
This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The feasibility, acceptability, and clinical effects of the nurse-led, very brief, preoperative mindfulness based intervention for hip and knee replacement patients will be investigated relative to nurse-led preoperative pain psychoeducation.
A secondary sub-analysis will compare two different styles of mindfulness practice (mindfulness of breath vs. mindfulness of pain) relative to preoperative pain psychoeducation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18,
- •Scheduled to undergo unilateral total knee arthroplasty
排除标准
- •Cognitive impairment preventing completion of study procedures.
- •Current cancer diagnosis,
- •Contralateral knee replaced in the previous 3 months,
- •Intent to have contralateral knee replaced or other, additional surgical procedure during the study period,
- •Intent to add new pain treatments during the study period (except for what is part of the study),
- •Other unstable illness judged by medical staff to interfere with study treatment.
结局指标
主要结局
Change in Pain Intensity Numeric Rating Scale
时间窗: baseline and after the 15 minute preoperative nurse visit
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
次要结局
- Change in Pain Unpleasantness Numeric Rating Scale(baseline and after the 15 minute preoperative nurse visit)
- Change in Pain Medication Desire Numeric Rating Scale(baseline and after the 15 minute preoperative nurse visit)
- Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0(During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment)
研究者
Adam Hanley
Assistant Professor
University of Utah