Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in Preoperative Pain Intensity
研究概览
简要总结
This was a single site, three-arm, parallel group randomized clinical trial that compared the effect of three preoperative psychosocial interventions on knee and hip replacement patients' preoperative pain intensity and postoperative pain intensity, pain unpleasantness, and opioid use.
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
- Double (Participant, Outcomes Assessor)
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
- •English-speaking males or females.
- •18 years old or older
- •Patients within the University of Utah Hospital system
- •Patients attending Joint Academy to prepare for either hip or knee replacement surgery
排除标准
- •Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
研究组 & 干预措施
Mindfulness of Breath
干预措施: Mindfulness of Breath (Behavioral)
Mindfulness of Pain
干预措施: Mindfulness of Pain (Behavioral)
Cognitive-Behaviorally Based Pain Psychoeducation
干预措施: Cognitive-Behaviorally Based Pain Psychoeducation (Behavioral)
结局指标
主要结局
Change in Preoperative Pain Intensity
时间窗: Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
Change in Postoperative Pain Intensity
时间窗: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
次要结局
- Change in Postoperative Pain Unpleasantness(Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.)
- Change in Postoperative Opioid Use(Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.)
研究者
Adam Hanley
Assistant Professor
University of Utah