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临床试验/NCT04039269
NCT04039269Unknown不适用

Could Long Term Memory Created by Preoperative Video Information Reduce Post Operative Behavioral Change?

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
192
试验地点
1
主要终点
Incidences of post operative behavioral changes

研究概览

简要总结

The study is designed to test the hypothesis that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.

详细描述

Emergence agitation (EA) and Post operative behavioral change (PHC) are unpleasant experiences occurred in children after general anesthesia (GA). Previous study reported that the patient who had marked EA tended to have new-onset of postoperative maladaptive behavioral changes.Both pharmacologic and non pharmacologic interventions such as preoperative video information, hand held video games were used to reduce preoperative anxiety, EA and Post operative behavioral changes. In term of memory creation, short term memory (STM) was created. Later that the formation of memory trace requires time, and that this trace remains fragile until the long term memory formation process has been completed. In this study, the investigators hypothetize that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.

研究设计

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

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •outpatient elective surgery
  • •aged between 3-14 years
  • •ASA physical status I-II

排除标准

  • •mental retardation
  • •patient's telephone contact not available
  • •emergency case
  • •having ICU admission plan postoperative

研究组 & 干预措施

single (watch 1 time)

Active Comparator

Preoperative video information

干预措施: Preoperative video information (Other)

Multiple (watch > 3 times)

Active Comparator

Preoperative video information

干预措施: Preoperative video information (Other)

conventional (do not watch)

No Intervention

Do not watch video

结局指标

主要结局

Incidences of post operative behavioral changes

时间窗: up to3 months post operative period

Use PHBQ (post operative behavioral questionnaire) Postive for postoperative behavioral change: 10% change from baseline sum score

次要结局

  • Incidences of Emergence agitation(evaluate PAED scale in the first 5 minutes after patient arrive PACU)
  • Child's anxiety level at induction(mYpas will be evaluated immediately after the patient arrives into the operating room)
  • Parental's anxiety level at induction(Evaluate 15 minutes before start anesthesia induction)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ngamjit Pattaravit

Assistant Professor, Dr

Prince of Songkla University

研究点 (1)

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