深触摸压力对小儿患者出现搅动的影响 (HUGGY)
深层触摸压力对接受扁桃体切除术和腺苷酸切除术的小儿患者出现躁动的影响：一项前瞻性随机对照研究
The goal of this clinical trial is to determine if deep touch pressure (DTP) can reduce emergence agitation (EA) in pediatric patients aged 3 to 10 years undergoing tonsillectomy and adenoidectomy under general anesthesia. The main questions it aims to answer are:
Does deep touch pressure (DTP) using a compression vest reduce the incidence of emergence agitation (EA) in the recovery room?
Does DTP reduce the severity of EA, as measured by the Pediatric Assessment of Emergence Delirium (PAED) scale?
Researchers will compare:
Intervention Group: Pediatric patients who receive DTP using the HUGgy compression vest during the recovery period.
Control Group: Pediatric patients who receive standard postoperative care without DTP.
Participants will:
Be randomly assigned to either the intervention group (DTP) or the control group.
Undergo standard general anesthesia for tonsillectomy and adenoidectomy.
Wear the HUGgy compression vest if assigned to the intervention group.
Be monitored for emergence agitation using the PAED scale and FLACC pain scale in the recovery room.
Receive rescue medication (nalbuphine) if severe EA occurs.
This study will help determine if DTP can be used as a safe and effective non-pharmacological method to reduce emergence agitation in pediatric patients.
研究概览
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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Seoul
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Seoul、Seoul、韩国
- Seoul National University Children's Hospital
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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:
- Pediatric patients aged 3 to 10 years scheduled for tonsillectomy and adenoidectomy under general anesthesia.
Exclusion Criteria:
- Emergency surgery.
- Known neurological disorders (e.g., epilepsy, cerebral palsy).
- Skin disorders or injuries on the chest or upper body that prevent safe use of the compression vest (HUGgy).
- History of severe psychiatric disorders (e.g., autism spectrum disorder, severe anxiety disorder).
- History of severe allergic reactions to anesthesia.
- Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制组
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实验性的：DTP组
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This intervention involves the use of a HUGgy compression vest, a wearable device that provides deep touch pressure (DTP) to pediatric patients undergoing tonsillectomy and adenoidectomy under general anesthesia. The vest is worn by patients immediately after surgery, and pressure is applied to provide calming sensory input. The pressure level is adjusted based on the manufacturer's guidelines, providing a gentle, even compression to reduce emergence agitation (EA) during the recovery period. |
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 |
|---|---|---|
|
Incidence of Emergence Agitation in Post-anesthesia care unit
大体时间：Within 30 minutes of recovery room admission, at evaluable assessments
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The incidence of emergence agitation (EA) is defined as a PAED (Pediatric Assessment of Emergence Delirium) scale score 10 or greater within the first 30 minutes after admission to the post-anesthesia care unit |
Within 30 minutes of recovery room admission, at evaluable assessments
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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PACU严重出现搅动（EA）的发生率
大体时间：从PACU入院到出院（最多1小时）
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从PACU入院到出院（最多1小时）
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PACU的最大FLACC疼痛评分
大体时间：从PACU入院到出院（最多1小时）
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从PACU入院到出院（最多1小时）
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PACU停留时间
大体时间：从PACU入院到出院（最多1小时）
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从PACU入院到出院（最多1小时）
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PACU的救援药物使用
大体时间：从PACU入院到出院（最多1小时）
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从PACU入院到出院（最多1小时）
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遵守深触摸压力（DTP）干预
大体时间：从PACU入院到出院（最多1小时）
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从PACU入院到出院（最多1小时）
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Maximum PAED Scale Score in Post-Anesthesia Care Unit
大体时间：From PACU admission to discharge (up to 1 hour)
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From PACU admission to discharge (up to 1 hour). |
From PACU admission to discharge (up to 1 hour)
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合作者和调查者
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
- 2503-017-1620
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
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