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CTRI Number  CTRI/2020/05/025461 [Registered on: 29/05/2020] Trial Registered Prospectively
Last Modified On: 20/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Changes in behaviour of children after day-care surgery 
Scientific Title of Study   Behavioural changes in children after ambulatory surgery under anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandhya Yaddanapudi 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department Of Anaesthesia and Intensive Care, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9872005576  
Fax    
Email  sandhya.yaddanapudi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandhya Yaddanapudi 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department Of Anaesthesia and Intensive Care, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9872005576  
Fax    
Email  sandhya.yaddanapudi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sankho Choudhury 
Designation  Juniour Resident 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department Of Anaesthesia and Intensive Care, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  8910858049  
Fax    
Email  sankhochoudhury12@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive Care 
Address  Postgraduate Institute of Medical Education and Research, Chandigarh, India 160012 
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 Sandhya Yaddanapudi  Postgraduate Institute of Medical Education and Research, PGIMER  APC OT, Level 6, Advanced Paediatric Centre
Chandigarh
CHANDIGARH 
9872005576

sandhya.yaddanapudi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z75||Problems related to medical facilities and other health care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children belonging to ASA I and II
Children with English and/or Hindi speaking parents
Children posted for ambulatory/ day care study 
 
ExclusionCriteria 
Details  Children with developmental delay or neurocognitive disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the incidence of behavioural changes on postoperative day 1, 7 and 14 using post-hospitalisation behavioural questionnaire - ambulatory surgery (PHBQ-AS)  1, 7 and 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
To identify risk factors associated with post-operative behavioural changes  1, 7 and 14 days 
 
Target Sample Size   Total Sample Size="217"
Sample Size from India="217" 
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)   01/06/2020 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Background - Hospitalisation, particularly surgery is a major cause of stress for children. It may impact his/her psychological and social development or may affect the response to subsequent medical care in the future. 
Aim of study - To assess the incidence and pattern of behavioural changes in children undergoing ambulatory surgery and to identify the risk factors associated with post-operative behavioural changes.
Primary objective - To quantify the incidence of behavioural changes on post-operative day 1, 7 and 14 using post hospitalisation behavioural questionnaire (PBHQ-AS).
Secondary objective - To identify risk factors associated with post operative behavioural changes.
Materials and methods - A prospective cohort observational study will be conducted in Paediatric OT, Advanced Paediatric Centre, PGIMER, Chandigarh. Demographic characteristics, child’s and parents education, socio-economic status of family, child’s temperament (EASI scale), pre-operative anxiety (mYPAS scale), induction compliance checklist (ICC) prior to anaesthesia, emergence delirium (PAED scale) will be recorded which have been considered risk factors in previous studies. Following surgery the parents will be interviews via phone call on post-operative day 1, 7 and 14 to assess the child’s post-operative pain measure (PPPM scale) and post-operative behaviour (PHBQ-AS).
Analysis - Based on the above mentioned characteristics the study will aim to assess the incidence and risk factors related to behaviour changes on Indian children and the impact it has on the future outcome related to hospitalisation and surgery. This will be helpful in guiding us towards improvements in our approach toward paediatric population who are taken up for surgical procedures in the future.

 
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