Cold Application on Pain During Chest Tube Removal
Efficacy of Cold Application on Pain During Chest Tube Removal: A Randomized Controlled Trial : A CONSORT Compliant Article
Abstract Objectives: Use of analgesics is the most common method to alleviate the pain induced by chest tube removal (CTR), but patient response to medication can vary and may not be achieved complete relaxation. This study was to determine the effectiveness of cold application in combination with standard analgesic administration before CTR on CTR-induced pain.
Methods: A prospective, randomized, single-blind, placebo sham-controlled study was conducted. In addition to the same routine care, subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR, whereas subjects in the placebo sham group (n = 30) received tap water packs. Numerical rating scale was used to measured pain intensity before, immediately after, and 10 minutes after CTR.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- (a) age greater than 20 years, (b) single chest-tube insertion, (c) first-time insertion of the chest tube, (d) ability to verbally report pain, (e) body mass index of < 30 kg/m2, and (f) normal vital signs.
Exclusion Criteria:
- cold urticaria
学习计划
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：cold application (experimental group)
subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR
|
We manufactured two ice packs (17 × 12 cm) with a combined weight of 600 g. The ice packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the ice packs was approximately 25 cm in diameter around the chest tube. For patients of the experimental group, they were received 15-minutes cold application. |
|
假比较器：tap water packs application (sham group)
subjects in the sham group (n = 30) received tap water packs.
|
We manufactured two tap water packs (17 × 12 cm) with a combined weight of 600 g. The tap water packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the tap water packs was approximately 25 cm in diameter around the chest tube. For patients of the sham group, they were received 15-minutes tap water application. |
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 |
|---|---|---|
|
numerical rating scale (NRS)
大体时间：before cold application
|
the intensity of pain at the chest tube replacement
|
before cold application
|
|
numerical rating scale (NRS)
大体时间：immediately after chest tube removal
|
the intensity of pain at the chest tube removal
|
immediately after chest tube removal
|
|
numerical rating scale (NRS)
大体时间：10 minutes after chest tube removal
|
the intensity of pain at the chest tube removal
|
10 minutes after chest tube removal
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 103044
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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cold application的临床试验
-
University of Colorado, DenverJohns Hopkins University完全的
-
Capital Health, CanadaSunnybrook Health Sciences Centre; Erasmus Medical Center; IWK Health Centre; Afexa Life Sciences... 和其他合作者完全的