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临床试验/NCT02185976
NCT02185976Unknown不适用

Preoperative Anxiety in Paediatric Patients; do Cartoons Help?

Balikesir University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月1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
2
主要终点
anxiety score

研究概览

简要总结

Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a special group who need special attention. Some studies have shown that cartoons are a very good tool for distraction in the preoperative period for children.

Our hypothesis is that children watching Cartoons in the preoperative period will have less anxiety and will be fit with preparation.

详细描述

After local ethics committee approval 60 patients scheduled for various types of surgery will be included.

On the operation day patients are going to be evaluated in the preoperative preparation room. For anxiety evaluation the modified yale preoperative anxiety scale will be used. After this first evaluation patients are going to be separated randomly into two groups; group R (routine) and group C (cartoon). All patients are going to be premedicated with midazolam. The first group will receive their premedication straight after the first evaluation and their response will be recorded as easy, moderate, difficult, does not accept. Group C will choose a cartoon movie (5 different movies are recorded and will be shown through a tablet PC)) and will begin to watch it. After 5 minutes they will receive their premedication and their response will also be recorded. After 30 minutes a physician will try to insert an IV line and the response of the child will also be evaluated and recorded as easy, moderate, difficult and does not allow. Afterwards the patient will be transported into the operation room. In the operation room anesthesia will be induced via Sevoflurane and the response to mask anesthesia will be evaluated with the mask score as it is described before in previous studies. Patients in Group C will continue to watch the cartoon movie until the induction of anesthesia. And the modified yale score will also be reevaluated and recorded.

The family anxiety will be evaluated with the State Trait Anxiety Inventory Scale.

The family and the child will also be interviewed separately, 4 prepared standard questions will be asked in order to understand how the family described the operation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • family approval
  • age between 3-9
  • scheduled for surgery under general anesthesia

排除标准

  • history of physiatric disease
  • regular medication
  • previous history of anesthesia/sedation

结局指标

主要结局

anxiety score

时间窗: at the beginning and before induction of anesthesia

the anxiety score of included patients is going to be evaluated at the beginning in the preparation room and once again in the operation room before induction.

次要结局

  • family anxiety scores(Before operation during the first examination)

研究者

发起方
Balikesir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

hafize fisun demir

Assistant Professor

Balikesir University

研究点 (2)

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