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CTRI Number  CTRI/2024/03/064529 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of interventions like screen watching or anxiety medicine on preoperative anxiety in children under general anaesthesia 
Scientific Title of Study   To study the effect of oral midazolam 0.5 mg/ kg, video gaming and cartoon watching onpreoperative anxiety in children posted for elective surgeries under general anaesthesia :a prospective randomized comparative study at department of Anaesthesia , S.M.S Medical College, Jaipur during 2022-2025. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Samridhi Nanda 
Designation  Professor 
Affiliation  Sawai Man Singh Hospital 
Address  Department of Anaesthesia, Sawai Man Singh Hospital, Ram Singh Road, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  01412518680  
Fax    
Email  samridhinanda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Samridhi Nanda 
Designation  Professor 
Affiliation  Sawai Man Singh Hospital 
Address  Department of Anaesthesia, Sawai Man Singh Hospital, Ram Singh Road, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  01412518680  
Fax    
Email  samridhinanda@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prachi Khatri 
Designation  Junior Resident 
Affiliation  Sawai Man Singh Hospital 
Address  Department of Anaesthesia, Sawai Man Singh Hospital, Ram Singh Road, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  01412518680  
Fax    
Email  prachikhatri959@gmail.com  
 
Source of Monetary or Material Support  
Sawai Man Singh Medical College, Jaipur 
 
Primary Sponsor  
Name  Sawai Man Singh Hospital 
Address  Department of Anaesthesia, Sawai Man Singh Hospital, Ram Singh Road, Jaipur 
Type of Sponsor  Government medical college 
 
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 Samridhi Nanda  Ophthalmology OT, JK Lon OT, ENT OT  Department of Anaesthesia, Sawai Man Singh Hospital and attached group of hospitals, Ram Singh Road, Jaipur
Jaipur
RAJASTHAN 		 01412518680

samridhinanda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of ethics committee, SMS Medical College and attached hospitals, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  We will include 102 consecutive children aged 5 to 12 years, with the American
Society of Anesthesiologists physical status I-II, and who will be scheduled for elective surgeries
1.Children between 5-12 years of age posted for elective surgeries under general anaesthesia
2.Giving consent for any of the three groups
3.American society of Anaesthesiologists physical status I-II 
 
ExclusionCriteria 
Details  1.History of chronic diseases( tuberculosis, bronchial asthma, diabetes mellitus, rheumatoid arthritis)
2.History of develop-mental delay
3.History of prematurity
4.History of neurological diseases
5.History of hearing /visual impairment
6.History of psycho active medication use
7.History of previous surgery and refusal to participate in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean change in pre operative anxiety- mYPAS (T2-T0)
Mean change in pre procedural anxiety- mYPAS (T1-T0)
 		 T0- Preoperatively, 30 minutes before surgery mYPAS (T0)
T1- Preoperatively, 30 min after the intervention, before wheeling in the patient(mYPAS)
T2- Preoperatively, just before induction, after the patient is wheeled in (mYPAS) 
 
Secondary Outcome  
Outcome  TimePoints 
Mean mask acceptance scale (4 point mask acceptance scale)
Proportion of cases with emergence agitation
Mean anaesthesia emergence score (PAEDS)
Mean parental satisfaction score (VAS-S) 		 T1- Preoperatively, 30 min after the intervention, before wheeling in the patient VAS-S
T2- Preoperatively , at the time of induction ( 4-point Mask Acceptance scale)
T3- Postoperatively, at the time of reversal (WATCHA, PAEDS) 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   01/04/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Pre-operative anxiety in children is a well-known entity. Various methods have been used to address the concern. Both pharmacological and non-pharmacological methods have been tried. Midazolam stands out in this regard. In the current scenario, where children are addicted to screens, utilising this in clinical practice may be an effective way to get past the preoperative anxiety. 
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