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临床试验/NCT06634680
NCT06634680已完成不适用

Effects of Different Parental Involvement on Anxiety and Delirium in Children Undergoing Elective ENT Surgery

Karaman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Patients anxiety-Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.

研究概览

简要总结

Induction of anesthesia in surgical procedures can be a distressing process for both children and their parents. Nonpharmacological behavioral interventions, unlike sedative medications, can reduce children's anxiety without adverse effects. The effect of having both parents present during anesthesia induction on children's anxiety and parents' anxiety has not yet been documented.

This study will aim to evaluate the effect of having both parents present during anesthesia induction on children's and parental anxiety during the perioperative period.

详细描述

Surgery can be very stressful for patients, especially children. Studies show that 50-75% of children experience fear and anxiety when undergoing surgery and being put under anesthesia. This anxiety can have adverse effects on their recovery, leading to more extended hospital stays, increased pain, and behavioral issues. To address this, various medical and non-medical approaches are used to ease children's fears. One such approach is allowing parents to be with their children until the anesthesia takes effect. This study aims to assess how having both parents present during this time impacts the child's anxiety levels.

The effect of parental presence on the anxiety of children and parents was studied in various studies. Whether both parents affect anxiety has not been studied yet. In this study the investigators will evaluate the anxiety of children by using mYPAS.

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

  • 80 children of both sex, aged 5-12 years with ASA physical Status I-II will be enrolled

排除标准

  • Mentally challenged
  • Deaf Child
  • Cerebral Palsy
  • Premedicated Child
  • Language Problem
  • Uncooperative
  • History of psychiatric disease in children or the parents
  • Previous surgery or anesthesia history

结局指标

主要结局

Patients anxiety-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 23.3 to 100, with higher scores indicating greater anxiety.

次要结局

  • Emergence delirium-Pediatric Anesthesia Emergence Delirium Scale (PAEDS)(Perioperative period)
  • Parent anxiety-STAI(Perioperative period)

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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