认知行为疗法以优化术后恢复 (COPE):在四肢骨折患者中进行随机对照可行性试验
Kyle Gouveia1, Sheila Sprague2, Jodi L Gallant1
1Department of Surgery,, Division of Orthopaedic Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Pilot and feasibility studies
|January 11, 2025
概括
这项试点研究探讨了在线认知行为疗法 (CBT),用于手术后的疼痛后,四肢骨折. 虽然可行,但招聘和合规方面的挑战需要在未来的试验中解决.
科学领域:
- 整形外科手术 整形外科手术
- 心理学 心理学 心理学
- 数字健康数字健康
背景情况:
- 在四肢骨折手术后,报告有高比例的慢性术后疼痛 (高达三分之二).
- 心理治疗干预措施在改善应对和减少骨折患者的体质警觉方面显示出有前途.
- 在线认知行为疗法 (CBT) 可能为治疗术后疼痛提供了一个可扩展的解决方案.
研究的目的:
- 评估随机对照试验 (RCT) 在线CBT在手术管理的四肢骨折患者的可行性和可接受性.
- 为了评估最终试验的招募率,治疗遵守率,协议遵守率和随访率.
主要方法:
- 一个单一中心的内部试点研究进行了10个月.
- 94名手术治疗四肢骨折的参与者被随机分配到在线CBT或常规护理.
- 在12个月的随访期间,对关键试验指标使用"交通信号灯"系统 (绿色,黄色,红色) 评估可行性.
主要成果:
- 招聘取得了"黄灯"的地位,在10个月内招收了94名参与者.
- 完成CBT计划的结果是"黄灯" (60%完成模块),但40%的人退出 ("红灯").
- 协议的遵守 (88%) 和12个月的随访 (85%) 被评为"黄灯".
结论:
- 一个明确的,多中心试验比较CBT和常规护理持续的术后疼痛是可行的.
- 招生,CBT合规和后续工作的挑战需要修改协议.
- 加强参与和合规的策略将在最终试验中实施.
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