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临床试验/CTRI/2025/03/083294
CTRI/2025/03/083294尚未招募不适用

Comparison Of The Efficacy Of Virtual, Physical And No Parental Presence In Reduction Of Pre-Operative Anxiety In Paediatric Patients Undergoing General Aanaesthesia - A Randomised Controlled Trial.

Prof Dr YS Payal1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年4月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
Paediatric Pre Operative Anxiety Using mYPAS Scoring System

研究概览

简要总结

It Is Well Documented That Many Children Report Fear And Become Distressed During Anaesthesia Induction. Studies Have Shown That Approximately 50 Percent Of Children Aged 3-12 Had High Level Anxiety At Induction Of Anaesthesia Which Peaked When The Anaesthesia Provider Introduced The Face Mask. Anxiety Induced Stimulation Of Autonomic And Endocrine System, Heart Rate, Blood Pressure, Cardiac Contractility, Release Of Catecholamines Can Interfere With The Process Of Smooth Induction. Elevated Anxiety Has Also Been Linked To Increased Post Surgical Pain Perception, Distress, Post Operative Agitation, Delirium And Persistent Adverse Behavioural Patterns After Discharge. Children Aged 2-7 Years Are More Likely To Experience Fear And Separation Anxiety Of Being Separated From Parents.Various Methodologies Have Been Studied To Reduce A Child’s Anxiety. Pharmacological Measures Like Premedication With Benzodiazepines And Non Pharmacological Measures Like Virtual Reality, Musical Interventions, Parental Presence In Operating Room Have Been Employed. Physical Parental Presence Is A Debatable Topic. A Distressed Parent May Worsen A Child’s Anxiety Whereas The Presence Of A Caregiver May Significantly Reduce Anxiety In An Impressionable Young Child. Virtual Parental Presence Is A Relatively Newer Modality Allowing Caregivers To Be Present At The Time Of Induction. The Aim Of This Study Is To Compare The Effect Of Physical, Virtual And No Parental Presence, In Addition To Standard Care, On Pre Operative Anxiety Of Paediatric Patients Aged 3-8 Years Undergoing Induction With General Anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children From Ages 3 Years To 8 Years Old
  • ASA Physical Status I, II 3.Planned Inhalational/IV induction 4.Inpatient child 5.English/Hindi Speaking Parents And Their Child.

排除标准

  • Children With Developmental Delay 2.Children With Psychological/ Emotional Disorders 3.Children With Altered Mental Status
  • Children Who Are Not Accompanied By Someone Able To Give Consent 5.Children Presenting For Emergency Surgery 6.Family History Or Personal History Of Malignant Hyperthermia / Risk Of MH 7.Children With Past History Of Violent Behaviours During Induction Of Anaesthesia 8.Consent Not Obtained Or Withdrawal Of Consent 9.Cancellation Of Surgery.

结局指标

主要结局

Paediatric Pre Operative Anxiety Using mYPAS Scoring System

时间窗: 1.One Day Prior To Surgery,In | The Ward To Establish | Baseline Anxiety Levels. | 2. Before Induction, In Pre-Operative Area | 3. During Induction

次要结局

  • i)To Compare The Parental Satisfaction In All The Three Groups Using Likert Scale.((ii)To Compare The Compliance Of Procedure In Physical And Virtual Parental Presence.)

研究者

发起方
Prof Dr YS Payal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Prof Dr Y S Payal

AIIMS,Rishikesh

研究点 (1)

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