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CTRI Number  CTRI/2019/01/017058 [Registered on: 14/01/2019] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Parental Anxiety in children undergoing surgery a question based study.  
Scientific Title of Study   Parental Anxiety in children undergoing surgery, an observational study 
Trial Acronym  PAICS Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alok Kumar Sahoo 
Designation  Assistant Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE 
Address  Room no 508, I block, 5th Floor, Sijua, AIIMS

Khordha
ORISSA
751019
India 
Phone  09438884160  
Fax    
Email  alokks108@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alok Kumar Sahoo 
Designation  Assistant Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE 
Address  Department of Anaesthesiology, Room No 508,Sijua, AIIMS

Khordha
ORISSA
751019
India 
Phone  09438884160  
Fax    
Email  alokks108@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alok Kumar Sahoo 
Designation  Assistant Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE 
Address  Department of Anaesthesiology, Room No 508,Sijua, AIIMS

Khordha
ORISSA
751019
India 
Phone  09438884160  
Fax    
Email  alokks108@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,Sijua, AIIMS, Bhubaneswar 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Sijua, Bhubaneswar 
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 
alok kumar sahoo  AIIMS  Department of Anaesthesiology, Room No 508,Sijua, AIIMS
Khordha
ORISSA 
9438884160

alokks108@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
institutional ethics committee  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  parents of the child undergoing surgery 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All the parents whose children undergoing elective surgery. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Prevalence of preoperative anxiety among parents whose child is undergoing surgery.   preoperative 24hr period  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1- To measure the education status of parents & its relation with the level of
anxiety.
2- to measure socioeconomic status of parents & its relation with the level of anxiety.

3- to see the association of preop & postop anxiety WITH
-duration, magnitude of surgery
-sex, age & number of children.
-waiting time for surgery & order of surgery
 
perioperative period till 3 days or discharge 
 
Target Sample Size
Modification(s)  
Total Sample Size="216"
Sample Size from India="216" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/01/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Surgery and Hospitalisation of a child and has a very stressful consequence for the child and their parents. Perioperative anxiety is a common phenomenon and it starts from the admission till child get discharged cured.   [2,3]. Various literature described a high level of parental anxiety in the child’s preoperative period. Mothers are more prone to experience anxiety before their child’s surgery than fathers are and divorced parents and parents with lower educational levels rate themselves as significantly more anxious preoperatively. The parental anxiety usually transferred to the child, which leads to the stressful and very anxious child before surgery. 4   Increased preoperative anxiety in children has been shown to correlate with increased postoperative pain, analgesic requirements and long-lasting psychological effects on the child’s response to subsequent medical care and interference with normal development .4

 

Education plays important role in controlling anxiety with low education level was significantly associated with anxiety and depression.5 Furthermore, some study also shows that Parental anxiety levels did not correlate with civil or educational status 4.

Cultural and ethnic background influences the anxiety of parents and children. Apart from this, there are almost negligible Indian data or studies available about the parental anxiety in preop area.

 

Hence, we plan this study to identify the prevalence of level of anxiety in parents of children who will undergo various surgeries and their relationship with the education level, financial status of parent, age & sex of the child in the preoperative area.

 
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