休息:为接受全膝关节置换的患者进行手术前量身定制的睡眠干预 - 随机对照试验的可行性研究
Wendy Bertram1,2, Chris Penfold3, Joel Glynn4
1Musculoskeletal Research Unit, University of Bristol Medical School, Bristol, UK wendy.bertram@bristol.ac.uk.
BMJ open
|March 20, 2024
概括
这项研究发现,对于全膝关节置换患者的手术前睡眠干预是可行的. 随着设计调整,一个完整的试验评估了REST干预.
科学领域:
- 整形外科手术 整形外科手术
- 睡眠医学 睡眠医学
- 临床试验设计 临床试验设计
背景情况:
- 在等待全膝关节置换的患者中,睡眠障碍很常见.
- 为了解决这个问题,开发了一种量身定制的手术前睡眠干预 (REST).
研究的目的:
- 评估对REST干预进行随机对照试验 (RCT) 的可行性.
- 探索患者和从业人员对研究程序和干预措施的可接受性.
主要方法:
- 一个双臂,双中心可行性RCT与1:1随机化.
- 包括患者和扩展范围从业人员 (ESP) 采访的定性组成部分.
- 评估招聘,坚持和结果完成率.
主要成果:
- 57名患者被随机分配,其中20人在研究时间表内接受手术.
- 干预的坚持率很高 (89%);70%完成了手术前和26%手术后的结果.
- 定性数据表明该研究和干预措施的可接受性很好.
结论:
- 通过对研究过程和设计进行修改,REST干预试验是可行的.
- 进一步的修正可以支持一个完整的RCT评估REST干预的有效性.
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