Comparing the Effects of an Audio-Recorded Brief Mindfulness-Based Intervention With a Nurse-Led Brief Mindfulness-Based Intervention for Preoperative Knee and Hip Replacement Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Pain Intensity Numeric Rating Scale
研究概览
简要总结
This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a nurse-led, very brief, preoperative mindfulness-based intervention for hip and knee replacement patients will be investigated relative to an audio-recorded very brief, preoperative mindfulness-based intervention delivered during the standard nurse consult and a nurse-led preoperative pain psychoeducation intervention during the standard nurse consult.
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 or hip arthroplasty
排除标准
- •Cognitive impairment preventing completion of study procedures.
- •Current cancer diagnosis,
- •Contralateral knee or hip replaced in the previous 3 months,
- •Intent to have contralateral knee or hip 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.
研究组 & 干预措施
Standard Pain Psychoeducation
干预措施: Standard Pain Management (Behavioral)
Audio-Recorded Mindfulness-Based Intervention
干预措施: Audio-Recorded Mindfulness-Based Intervention (Behavioral)
Nurse-Led Mindfulness-Based Intervention
干预措施: Nurse-Led Mindfulness-Based Intervention (Behavioral)
结局指标
主要结局
Change in Pain Intensity Numeric Rating Scale
时间窗: Baseline and after the 10 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 Medication Desire Numeric Rating Scale(Baseline and after the 10 minute preoperative nurse visit)
- Change in Pain Unpleasantness Numeric Rating Scale(Baseline and after the 10 minute preoperative nurse visit)
研究者
Adam Hanley
Assistant Professor
University of Utah