Psychosocial Support for Acute Hospital Pain and Distress
2020年3月4日 更新者：Eric Garland、University of Utah
The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by social workers to patients reporting uncontrolled pain during a hospital stay.
This study will examine the differential effects of brief mindfulness training, therapeutic suggestion, and psychoeducation for patients reporting uncontrolled pain.
研究概览
研究类型
介入性
注册 (实际的)
244
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
-
-
Utah
-
Salt Lake City、Utah、美国、84112
- University of Utah Hospital
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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 or older within the University of Utah Hospital system reporting "intolerable pain" or "inadequate pain control" on the Clinically Aligned Pain Assessment Tool (CAPA; Donaldson & Chapman, 2013).
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Mindfulness
15 minute mindfulness session
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The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.
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实验性的：Suggestion
15 minute therapeutic suggestion session
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The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
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有源比较器：Psychoeducation
15 minute psychoeducation session
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The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
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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 |
|---|---|---|
|
Pain intensity (numeric rating scale)
大体时间：Immediately prior to and following intervention
|
0-10 scale
|
Immediately prior to and following intervention
|
|
Pain unpleasantness (numeric rating scale)
大体时间：Immediately prior to and following intervention
|
0-10 scale
|
Immediately prior to and following intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Use of opioid analgesics
大体时间：24 hours prior to and following intervention
|
The total amount of opioid analgesic use will be computed during the 24 hours prior to and following intervention.
Opioid dose will be standardized and calculated using conventional morphine daily equivalent equianalgesic conversion tables.
|
24 hours prior to and following intervention
|
|
Anxiety (numeric rating scale)
大体时间：Immediately prior to and following intervention
|
0-10 scale
|
Immediately prior to and following intervention
|
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Relaxation (numeric rating scale)
大体时间：Immediately prior to and following intervention
|
0-10 scale
|
Immediately prior to and following intervention
|
|
Desire for opioids (numeric rating scale)
大体时间：Immediately prior to and following intervention
|
0-10 scale
|
Immediately prior to and following intervention
|
|
Positive body sensations (numeric rating scale)
大体时间：Immediately prior to and following intervention
|
0-10 scale
|
Immediately prior to and following intervention
|
|
Use of non-opioid analgesics (NSAID)
大体时间：Within 24 hours prior to and following intervention
|
The total amount of opioid analgesic use will be computed during the 24 hours prior to and following intervention.
NSAID dose will be standardized and calculated using conventional NSAID equianalgesic conversion tables.
|
Within 24 hours prior to and following 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。
调查人员
- 首席研究员：Eric L Garland, PhD、University of Utah
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。
一般刊物
- Donaldson, G., & Chapman, C.R. (2013). Pain management is more than just a number. University of Utah Health/Department of Anesthesiology. Salt Lake City, Utah: Department of Anesthesiology.
- Garland EL, Baker AK, Larsen P, Riquino MR, Priddy SE, Thomas E, Hanley AW, Galbraith P, Wanner N, Nakamura Y. Randomized Controlled Trial of Brief Mindfulness Training and Hypnotic Suggestion for Acute Pain Relief in the Hospital Setting. J Gen Intern Med. 2017 Oct;32(10):1106-1113. doi: 10.1007/s11606-017-4116-9. Epub 2017 Jul 12.
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)
2015年11月1日
初级完成 (实际的)
2018年10月1日
研究完成 (实际的)
2018年10月1日
研究注册日期
首次提交
2015年10月26日
首先提交符合 QC 标准的
2015年10月27日
首次发布 (估计)
2015年10月28日
研究记录更新
最后更新发布 (实际的)
2020年3月6日
上次提交的符合 QC 标准的更新
2020年3月4日
最后验证
2020年3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.