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临床试验/NCT06459089
NCT06459089招募中不适用

The Effects of Familiar Toy and Parental Presence on Perioperative Pediatric Anxiety

Karaman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.

研究概览

简要总结

This study will evaluate the effect of presence of favorite toy and parent during perioperative period on pediatric anxiety and emergence delirium. Half of the patients patients will be accompanied with their ownselected parent and the other half will be accompanied with their favorite toy in addition to their own selected parent.

详细描述

To reduce the incidence of preoperative anxiety in children, anesthesiologists have used a number of prevention strategies, including sedative premedication, parental presence during anesthetic induction, behavioral preparation programs, music therapy, hypnosis, and acupuncture.One of these distraction tool is familiar toy, children may also be comforted by familiar toys. Therefore, parent presence during perioperative period or playing with a favorite toy seems likely to alleviate preoperative anxiety in children. Until now, combination of these two method to reduce anxiety is not observed in literature. Then, the aim of this observational study is to evaluate the effect of both presence of favorite toy and parental presence compare to only parental presence during perioperative period on anxiety and emergence delirium in patients undergoing ambulatory surgery in our hospital's otorhinolaryngology department.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with ASA 1 and 2, Those who have the ability to speak and obey commands will be included.

排除标准

  • Mentally challenged Deaf Child Cerebral Palsy Premedicated Child Language Problem Unco-operative Previous surgery or anesthesia history

结局指标

主要结局

Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.

时间窗: Perioperative period

The mYPAS will be used to evaluate the anxiety level of children. The mYPAS is an observational measure of preoperative anxiety consisting of 27 items in 5 domains (activity, emotional expressivity, state of arousal, vocalization, and use of parents). The adjusted mYPAS total score ranges from 22.9 to 100, with higher scores indicating greater anxiety.

次要结局

  • Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room(Postoperative 1st day)

研究者

发起方
Karaman Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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