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
|
|
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
|
|
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
|
|
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
|
|
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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