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临床试验/NCT04979429
NCT04979429已完成不适用

Preventing Chronic Post-Surgical Pain and Prolonged Opioid Use: The Perioperative Pain Self-Management Program

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 401 人开始时间: 2021年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
401
试验地点
4
主要终点
Numeric Pain Rating Scale

研究概览

简要总结

This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management.

详细描述

Surgery can precipitate the development of both chronic pain and long-term opioid use. There is a need for strategies to augment perioperative pharmacotherapeutic management of pain with non-pharmacologic strategies to prevent long-term sequelae. Psychological interventions such as cognitive behavioral therapy (CBT) can effectively reduce distress and improve functioning among patients with chronic pain. While CBT has been used extensively in patients with established chronic pain, it has not been used as a preventive intervention targeting the transition from acute to chronic postsurgical pain. The Perioperative Pain Self-management (PePS) program has the potential to reduce the incidence of chronic post-surgical pain and long-term opioid use among Veterans. This study will: Examine the efficacy of PePS compared to standard care on 6-month pain (primary outcome), mood and functioning outcomes as well as time to post-surgical opioid and other analgesic use cessation.

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
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will be blinded to randomization status.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled for total hip, knee, or shoulder joint arthroplasty through the Iowa City, IA, Des Moines, IA, Minneapolis, IA, or Milwaukee WI, VA medical centers

排除标准

  • inability to complete study forms/procedures because of a language/literacy barrier
  • active bipolar or psychotic disorder
  • history of brain injury
  • CBT therapy within the past year
  • lack of access to a telephone for PePS sessions

研究组 & 干预措施

PePS

Experimental

4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.

干预措施: Perioperative Pain Self-management (PePS) (Behavioral)

Standard Care

No Intervention

Standard perioperative care.

结局指标

主要结局

Numeric Pain Rating Scale

时间窗: 6-months post-surgery

Surgical Site Pain The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.

次要结局

  • opioid use(time to cessation post surgery (weekly phone calls for the first 6 weeks))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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