跳至主要内容
临床试验/NCT05257304
NCT05257304Unknown不适用

EFFECTS OF REPEATED GENERAL ANAESTHESIA ON THE LEVEL OF PRE-PROCEDURE ANXIETY IN CHILDREN UNDERGOING RADIOTHERAPY.

Aga Khan University Hospital, Pakistan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8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
40
试验地点
1
主要终点
Anxiety score

研究概览

简要总结

Observation of pre-precedure anxiety in pre-operative suite in children from age 2-12yrs, undergoing radiotherapy under general anesthesia.

详细描述

Radiotherapy procedures are used to damage or destroy growing cancer cells.(1) This strategic use of ionized radiation is being practiced since the early 20th century and is very effective in destroying diseased cancer cells while sparing the healthy ones.(2) These procedures require patients to stay absolutely still, hence requiring general anesthesia in case of children compared to the adults. The treatment also requires multiple cycles of radiotherapy for which children have to undergo general anaesthesia multiple times.(3) Multiple anaesthetics for the same child may lead to preoperative anxiety, increased autonomic fluctuations, increased demand for anaesthetics and nausea/vomiting.(4-5) Pre-operative anxiety not only causes physical but also emotional and psychological trauma.(6) Such patients, subjected to anxiety, may face fear and potential hesitance in visiting the pre-anesthesia clinics for evaluation, induction and problems in pre-operative and recovery span.(7-8)It is therefore important to gauge the extent of this anxiety and to see whether it increases or decreases with subsequent cycles of treatment .Unless this is identified it will be difficult to put appropriate treatments in place.

Though previous studies are available on pre-operative anxiety in children but there has been little research about level of a child's anxiety under going repeated general anesthesia, especially during radiotherapy sessions. We were unable to identify any study on the subject in our literature search, a gap that needs research.

Several scales are available to evaluate anxiety in children(9), mYPAS scale is a standard It is also important to measure the anxiety levels of the parents accompanying the child, since this may have an effect on behavior.

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
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child of either gender
  • 2-12 years of age
  • ASA status (1,2 and stable 3)
  • Pre-school, school and non-school going
  • Scheduled for a radiotherapy procedure under general anesthesia for at least 3 cycles under GA

排除标准

  • Procedure to be done under sedation alone
  • Children with developmental delay
  • Children coming with other relatives apart from parents.

结局指标

主要结局

Anxiety score

时间窗: First 3 radiotherapy cycles

Pre operative anxiety score would be assessed

次要结局

未报告次要终点

研究者

发起方
Aga Khan University Hospital, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sufiyan Nasir

Resident

Aga Khan University Hospital, Pakistan

研究点 (1)

Loading locations...

相似试验