Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera (ELAROP)
Pain management in premature infants is essential because they are exposed to repeated minor painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast, side-effect-free method, but no study exists on the contribution of acupuncture in the management of pain caused by the examination of the fundus in addition to conventional therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently effective.
Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort of premature newborns when examining the fundus with a digital camera.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Paris、法国、75019
- Hôpital Robert Debré
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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:
- Premature from 23+0 to 30sa+6d regardless of birth weight with 1st FO for ROP screening;
- Premature birth weights < 1250g with a 1st FO for ROP screening;
- Informed consent of the holder(s) of parental authority;
- Child benefiting from a social security system
Exclusion Criteria:
- Analgesic or sedative drug treatment (benzodiazepines, morphine and related) within 48 hours of the examination.
- Known chromosomal abnormality
学习计划
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：Laser Stimulation
laser pen acupuncture projecting an infrared beam with a wavelength of 905nm bilaterally for 30 seconds on each point.
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an acupuncture or placebo session will be performed 30 minutes before the fundus examination.
This session will last 5 minutes.
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安慰剂比较：Placebo
The placebo group will have an application of the pen according to the same extinguished laser criteria.
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an acupuncture or placebo session will be performed 30 minutes before the fundus examination.
This session will last 5 minutes.
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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 |
|---|---|---|
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score at PIPP (premature infant pain profile) ≥ 10
大体时间：24 hours
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Measurement of pain or discomfort defined by a PIPP score ≥ 10
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24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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pain and discomfort
大体时间：24 hours
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Assess pain and discomfort (score FANS).
The FANS score is a validated hetero-rating scale for assessing acute newborn pain when the face is difficult to analyse.
On the 0 to 10 side, the absence of pain is defined by a score < 3
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24 hours
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heart rate variability
大体时间：24 hours
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assessment of heart rate variability (NIPE score)
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24 hours
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合作者和调查者
调查人员
- 首席研究员：Farnoux Caroline, PHD、APHP
- 学习椅：Biran Valerie, PHD、APHP
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
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.
Laser stimulation的临床试验
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Second Affiliated Hospital of Xi'an Jiaotong University完全的
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Universidade Federal do Rio de Janeiro招聘中
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Derk Jan JagerUniversity Medical Center Groningen; UMC Utrecht; Fonds NutsOhra; Isala; Tandartspraktijk Bocht Oosterdiep 和其他合作者完全的