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CTRI Number  CTRI/2025/11/097479 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Anxiety in children 
Scientific Title of Study   Occurrence And Predictors Of Pre-Operative Anxiety In Pediatric Patients Undergoing Surgery: A Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinushree R 
Designation  Post Graduate student 
Affiliation  K S Hegde Medical Academy 
Address  5th floor, Anaesthesia And Operation Theatre Technology, K S Hegde Medical Academy, Deralakatte, Mangalore
Deralakatte, Mangaluru 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  7204497664  
Fax    
Email  chinnuvinugowda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prathima 
Designation  Assistant Professor And Co-ordinator 
Affiliation  K S Hegde Medical Academy 
Address  5th floor, Anaesthesia And Operation Theatre Technology, K S Hegde Medical Academy, Deralakatte, Mangalore
Deralakatte, Mangaluru 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845277289  
Fax    
Email  prathima603@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prathima 
Designation  Assistant Professor And Co-ordinator 
Affiliation  K S Hegde Medical Academy 
Address  5th floor, Anaesthesia And Operation Theatre Technology, K S Hegde Medical Academy, Deralakatte, Mangalore
Deralakatte, Mangaluru 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845277289  
Fax    
Email  prathima603@gmail.com  
 
Source of Monetary or Material Support  
Justice K S Hegde Charitable Hospital, Nithyanananda nagar, Deralakatte, Manglore, Dakshina Kannada district, 575018 Karnataka, India 
 
Primary Sponsor  
Name  Justice K S Hegde charitable hospital 
Address  Deralakatte, Mangaluru 575018 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Self  Deralakatte, Manglore 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vinushree R  Justice K S Hegde charitable hospital  1st floor, Operation Theatre, Department of Anaesthesiology and critical care, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru 575018
Dakshina Kannada
KARNATAKA 		 7204497664

chinnuvinugowda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
K S Hegde Medical Academy Institutional Ethics Committe   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Pediatric patients of age group 2-12 years and their parents
2. Pediatric patients with American Society of Anesthesiologists (ASA) grade I and II
 
 
ExclusionCriteria 
Details  1. Denial of consent
2. Emergency of surgery
3. Pediatric patients with neurological and psycological illness
4. Parents with known psychological illness
5. Parents having language barriers 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Occurrence and severity of pre-operative anxiety  3 time points
1. At baseline (the day before surgery during preoperative evaluation – Anxiety 1)
2. On the day of surgery in the preoperative holding area – Anxiety 2
3. During induction of anaesthesia – Anxiety 3 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the risk factors associated with pre-operative anxiety in pediatric patients  3 time points
1. At baseline (the day before surgery during preoperative evaluation – Anxiety 1)
2. On the day of surgery in the preoperative holding area – Anxiety 2
3. During induction of anaesthesia – Anxiety 3 
 
Target Sample Size   Total Sample Size="147"
Sample Size from India="147" 
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)   25/11/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 pediatric patients is a significant concern, as it can negatively impact both the perioperative experience and post-operative outcomes. High levels of anxiety in children can lead to increased physiological stress responses, resulting in physiological disturbances and delayed recovery. Despite its known impacts, pre-operative anxiety in pediatric patients remains under-researched, especially with regard to identifying specific risk factors and the influence of caregiver anxiety. This study is essential to bridge the existing knowledge gap, enhance understanding and guide targeted interventions for managing pre-operative anxiety in pediatric patients.
 
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