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临床试验/NCT04933201
NCT04933201Unknown不适用

Music for Postoperative Pain and Discomfort After Orbital Decompression

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Pain after orbital decompression

研究概览

简要总结

The purpose of this study is to evaluate the effect of music to the postoperative pain and discomfort after orbital decompression.

详细描述

To investigate the effect of music to the postoperative pain and discomfort after orbital decompression under general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 16-75 years old
  • diagnosed as thyroid eye disease
  • bone removal orbital decompression under general anesthesia

排除标准

  • any uncontrolled clinical problems
  • orbital decompression under local anesthesia
  • Reluctance to participate in clinical trials

结局指标

主要结局

Pain after orbital decompression

时间窗: 24 hour after recovery

Pain levels measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable ; this scale has been confirmed to be sensitive and reliable.Clinically significant postoperative pain was considered serious pain (NRS score ≥5).

次要结局

  • Discomfort after orbital decompression(24 hour after recovery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huijing Ye

Principal Investigator

Sun Yat-sen University

研究点 (1)

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Postoperative Music for Orbital Decompression | 临床试验