Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change in Preoperative Anxiety
研究概览
简要总结
This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at presentation between 18 and 65 years
- •Acute lower extremity fracture to be operatively managed
- •Glasgow Coma Scale of 15
- •English speaking
- •Willingness to participate in study
排除标准
- •Cognitive impairment
- •Pregnant or lactating woman
- •Current incarceration
- •Planned secondary procedure
结局指标
主要结局
Change in Preoperative Anxiety
时间窗: Immediately before to after the 7-minute preoperative intervention
Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater anxiety.
Change in Postoperative, In-patient Pain Unpleasantness
时间窗: Immediately before to after the 7-minute postoperative intervention
Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness.
次要结局
- Change in Postoperative, In-patient Anxiety(Immediately before to after the 7-minute postoperative intervention)
- Change in Preoperative Pain Intensity(Immediately before to after the 7-minute preoperative intervention)
- Change in Postoperative, In-patient Pain Intensity(Immediately before to after the 7-minute postoperative intervention)
- Change in Preoperative Pain Unpleasantness(Immediately before to after the 7-minute preoperative intervention)
研究者
Adam Hanley
Assistant Professor
University of Utah