A non-inferiority,randomized controlled trial on Information Based v/s Distraction Technique for preoperative anxiety reduction in children.

PGIMER1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2020年3月15日最近更新: 2020年6月3日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: PGIMER
入组人数: 80
试验地点: 1
主要终点: mYPAS Score

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a trial going to compare information based v/s distraction technique for anxiety reduction among 6-12ys children undergoing ambulatory surgery.80 children will be recruited. The purpose of the trial is to prove information based technique for induction is non-inferior to distraction techniques . Preoperative anxiety will be assessed by using mYPAS scoring is the primary objective of our study. Since we dint start recruiting itâ€™s difficult to comment on our findings.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 6.00 Year(s) 至 12.00 Year(s)（—）
性别: All

入选标准

•ASA 1 and 2 undergoing ambulatory surgery.

排除标准

•Mentally challenged Deaf child Cerebral palsy Premedicated child.

结局指标

主要结局

mYPAS Score

时间窗: Baseline | 10 minutes after intervention | During induction of anaesthesia

次要结局

Induction compliance checklist(During induction)
Analgesic requirement(Immediately after extubation, 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes.)
Emergence Agitation(Immediately after extubation, 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes.)
Parental anxiety(30 minutes before surgery)
pain scores(Immediately after extubation, 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes.)
Parental satisfaction(After surgery)
Negative outcome(15 days (telephonically))

研究者

发起方

PGIMER

申办方类型

Research institution and hospital

研究点 (1)

Loading locations...

相似试验

Unknown

不适用

Parenting With Anxiety: Helping Anxious Parents Raise Confident ChildrenChild AnxietyParent AnxietyParental WellbeingChild Wellbeing

NCT04755933University of Sussex3,508

尚未招募

2 期

Effect of showing videos to children undergoing eye daycare surgeries for stress reduction

CTRI/2019/10/021588All India Institute of Medical Sciences138

已完成

3 期

Experimental Medication For the Treatment of Generalized Anxiety DisorderAnxiety Disorder

NCT00097708Jazz Pharmaceuticals511

已完成

不适用

Interventions to Decrease Anxiety in Patients Undergoing Urodynamic TestingIncontinence

NCT02168556The Cleveland Clinic98

已完成

不适用

Trial for reduction of anxiety and fatigue -open studyHealthy adults

JPRN-UMIN000042928IMEQRD inc.20