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CTRI Number  CTRI/2017/10/009980 [Registered on: 03/10/2017] Trial Registered Retrospectively
Last Modified On: 18/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [GAMES AND TOYS FOR CHILDREN BEFORE ANAESTHESIA]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Measuring Anxiety and Stress before and after heart surgery undergoing children and their parents 
Scientific Title of Study   Perioperative anxiety and stress in children and parents undergoing congenital cardiac surgery: Effect of brief intervention 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K Ashok Kumar 
Designation  DM student 
Affiliation  All India Institute Of Medical Sciences(AIIMS) DELHI 
Address  Dept of Cardiac Anaesthesia 7th floor CN center AIIMS

New Delhi
DELHI
110029
India 
Phone  8860121602  
Fax    
Email  ashok.medickaramsi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sambhunath Das 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences(AIIMS) DELHI 
Address  Dept of Cardiac Anaesthesia 7th floor CN center AIIMS

New Delhi
DELHI
110029
India 
Phone  9868398105  
Fax    
Email  sambhu@aiims.ac.in  
 
Details of Contact Person
Public Query  
Name  K Ashok Kumar 
Designation  DM student 
Affiliation  All India Institute Of Medical Sciences(AIIMS) 
Address  Dept of Cardiac Anaesthesia 7th floor CN center AIIMS

New Delhi
DELHI
110029
India 
Phone  8860121602  
Fax    
Email  ashok.medickaramsi@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences, Ansari Nagar, New Delhi- 110029 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences 
Address  CN Center Ansari Nagar New Delhi- 110029 
Type of Sponsor  Research institution and hospital 
 
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 
K Ashok Kumar  All India Institute Of Medical Sciences(AIIMS)  Dept of Cardiac Anaesthesia 7th floor CN center
New Delhi
DELHI 		 8860121602

ashok.medickaramsi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee For Postgraduate Research, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Children with cardiac disease undergoing surgery and their parents,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  games and toys for children before anaesthesia for 5 minutes and hospital education for parents for 5 minutes  children were given toys and games before anaesthesia till going to sleep approximately it takes 5 minutes, and their parents were given hospital education explaining about environment and procedure for about 5minutes  
Comparator Agent  games and toys not given to children and no education about hospital for parents  only anxiety and stress scales will be applied for both parents and children. no intervention  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children undergoing elective cardiac surgery, aged between 5 to 15 years will be included in this study along with their parents 
 
ExclusionCriteria 
Details  emergency surgery, redo surgery, off pump cardiac surgeries, preoperative diagnosed psychiatric illness, patients with hearing and vision defects 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Effect of video, games and toys on relieving stress, anxiety, pain and improving mood in children undergoing cardiac surgery.
2. Effect of information, education and counselling on stress and anxiety of children and parents

 		 Five days before surgery to one month after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of stress and anxiety in parents and children undergoing cardiac surgery
2. Risk factors associated with stress and anxiety in parents and children undergoing cardiac surgery
 		 Five days before surgery to one month after surgery 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/11/2016 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT DONE 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Intoduction: Major advances in surgical treatment have improved outcomes for children with congenital heart disease. More attention is now being placed on the developmental and psychological outcomes of these children, realizing that any form of cardiac surgery is a major stress for children and their families. Children and their parents develop significant behavioral stress and anxiety before  surgery.
Methodoly: This study includes 60 children with CHD undergoing elective cardiac surgery in the age group 5 to 15 years. Parents will be selected from their respective children for this study. Study includes three time assessments of both children and parents. intervention in the form of games and toys given for children before anaesthesia and hospital education for respective children in intervention group of the study. Assessment of stress, anxiety and mood will be assessed for both child and parent. Pain will be assessed in child. Serum cortisol levels will be measured in children before and after surgery.

 
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