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CTRI Number  CTRI/2025/03/083294 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To Compare The Efficiency Of Physical, Virtual And No Parental Presence In Reducing Anxiety Before Surgery In Children Who Will Be Given General Anaesthesia 
Scientific Title of Study   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.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Y S Payal 
Designation  Professor 
Affiliation  AIIMS,Rishikesh 
Address  Department Of Anaesthesiology, Level 6, All India Institute Of Medical Sciences, Veerbhadra Marg, Pashulok, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9411789762  
Fax    
Email  dryspayal05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Y S Payal 
Designation  Professor 
Affiliation  AIIMS,Rishikesh 
Address  Department Of Anaesthesiology, Level 6, All India Institute Of Medical Sciences, Veerbhadra Marg, Pashulok, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9411789762  
Fax    
Email  dryspayal05@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jaspreet Kaur 
Designation  Post Graduate Resident 
Affiliation  AIIMS,Rishikesh 
Address  Department Of Anaesthesiology, Level 6, All India Institute Of Medical Sciences, Veerbhadra Marg, Pashulok, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8847487455  
Fax    
Email  kaurjaspreet3199@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences Rishikesh, Veerbhadra Marg, Pashulok, Rishikesh, India Pin Code 249203 
 
Primary Sponsor  
Name  Prof Dr YS Payal 
Address  Department Of Anaesthesiology, Level 6, All India Institute Of Medical Sciences, Rishikesh, Veerbhadra Marg, Pashulok, Rishikesh, Dehradun, India Pin Code 249203 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jaspreet Kaur  Operation Theatre Complex  Department Of Anaesthesiology,level 6, All India Institute Of Medical Sciences Rishikesh, Pashulok, Pin Code 249203
Dehradun
UTTARANCHAL 		 08847487455

kaurjaspreet3199@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No Parental Presence   No Parent Will Be Allowed To Accompany The Patient In The Operation Theatre For Anaesthesia Induction In Patients Randomised To No Parental Presence Group  
Intervention  Physical Parental Presence   Parent Will Be Allowed To Accompany The Patient In The Operation Theatre For Anaesthesia Induction In Patients Randomised To Physical Parental Presence Group 
Intervention  Virtual Parental Presence   Parent Will Be In Contact With The Patient Via Video Call In The Operation Theatre For Anaesthesia Induction In Patients Randomised To Virtual Parental Presence Group 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Children From Ages 3 Years To 8 Years Old
2. ASA Physical Status I, II
3.Planned Inhalational/IV induction
4.Inpatient child
5.English/Hindi Speaking Parents And Their Child 
 
ExclusionCriteria 
Details  1. Children With Developmental Delay
2.Children With Psychological/ Emotional Disorders
3.Children With Altered Mental Status
4. 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 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Paediatric Pre Operative Anxiety Using mYPAS Scoring System
 		 1.One Day Prior To Surgery,In
The Ward To Establish
Baseline Anxiety Levels.
2. Before Induction, In Pre-Operative Area
3. During Induction
 
 
Secondary Outcome  
Outcome  TimePoints 
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.
(iii)To Compare The Time Of First Requirement Of Post Op Analgesia  		 1.Parent induction experience - During The Post-Operative Period
2.Child Induction Behaviour Compliance - During Induction, Assessed Immediately
3.First Requirement Of Analgesia- During The Post-Operative Period
 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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.       
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