Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy
2020年8月24日 更新者:Adam Hanley、University of Utah
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.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
118
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Utah
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Salt Lake City、Utah、美国、84112
- University of Utah
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:痛苦的正念
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Mindfulness of Pain consisted of instruction in how to (1) zoom in to deconstruct pain into its constituent physical sensations and precisely map each sensation's spatial location, (2) use mindful breathing to zoom out and broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that were absent of sensation and pleasant sensations), and (3) shift attention from unpleasant sensations to neutral/pleasant sensations or experiences.
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实验性的:Mindfulness of Breath
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Mindfulness of Breath consisted of instruction in focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.
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有源比较器:Cognitive-Behaviorally Based Pain Psychoeducation
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Cognitive-Behaviorally Based Pain Psychoeducation consisted of psychoeducation about the link between thoughts, emotions, and behavior and provided instruction in the use logic to dispute maladaptive thoughts about pain that might otherwise exacerbate pain and distress.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Preoperative Pain Intensity
大体时间:Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
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Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
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Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
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Change in Postoperative Pain Intensity
大体时间:Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
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Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
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Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Postoperative Pain Unpleasantness
大体时间:Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
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Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
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Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
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Change in Postoperative Opioid Use
大体时间:Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
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Single-item, dichotomously scored (no vs. yes): "Did you take opioid medications in the last 24 hours?"
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Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Self-Transcendent State
大体时间:Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
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Self-transcendent state was measured with the Nondual Awareness Dimensional Assessment (NADAs; Hanley, Nakamura, & Garland, 2018).
The NADAs is a 3-item, Likert type (0-10) self-report scale specifically designed to measure alterations in the experience of self occasioned by mindfulness practice.
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Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
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Patient Confidence
大体时间:Completed immediately after the preoperative intervention
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Patients' confidence ("How confident are you that you could effectively use this pain management technique?") in using the pain management technique was assessed with a single item rated on a numeric rating scale (0-10), with 0 indicating no confidence and 10 representing complete confidence.
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Completed immediately after the preoperative intervention
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Patient Intent
大体时间:Completed immediately after the preoperative intervention
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Patients' intent to use the technique ("How likely are you to use this pain management technique?")
to use the pain management technique was assessed with a single item rated on a numeric rating scale (0-10), with 0 indicating no intent and 10 representing absolute intent.
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Completed immediately after the preoperative intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年10月29日
初级完成 (实际的)
2020年3月10日
研究完成 (实际的)
2020年8月13日
研究注册日期
首次提交
2020年8月13日
首先提交符合 QC 标准的
2020年8月17日
首次发布 (实际的)
2020年8月20日
研究记录更新
最后更新发布 (实际的)
2020年8月27日
上次提交的符合 QC 标准的更新
2020年8月24日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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