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CTRI Number  CTRI/2025/08/093114 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   This study looks at how epilepsy affects the way children aged 6 to 15 feel about themselves, their friendships, and their overall well-being, using both interviews and questionnaires at AIIMS Gorakhpur. 
Scientific Title of Study   The Impact of Epilepsy on Stigma Peer Relationship and Health Related Quality of Life among Children 6 to 15 Years A Mixed Method Approach at AIIMS Gorakhpur Uttar Pradesh 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Richa Singh 
Designation  M.Sc. Nursing Student  
Affiliation  College of Nursing, AIIMS Gorakhpur, Uttar Pradesh 
Address  College of Nursing MNC Building AIIMS Gorakhpur Uttar Pradesh 273008 India

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  6307847009  
Fax    
Email  richasingh08014@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Seema S Chavan 
Designation  Associate Professor 
Affiliation  College of Nursing, AIIMS Gorakhpur, Uttar Pradesh 
Address  College of Nursing MNC Building AIIMS Gorakhpur Uttar Pradesh 273008 India

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9353437981  
Fax    
Email  seemaschavan23@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Seema S Chavan 
Designation  Associate Professor 
Affiliation  College of Nursing, AIIMS Gorakhpur, Uttar Pradesh 
Address  College of Nursing MNC Building AIIMS Gorakhpur Uttar Pradesh 273008 India


UTTAR PRADESH
273008
India 
Phone  9353437981  
Fax    
Email  seemaschavan23@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Richa Singh 
Address  Nurses Girls Hostel AIIMS Gorakhpur Uttar Pradesh 273008 India 
Type of Sponsor  Other [Self] 
 
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 
Richa Singh  ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS) GORAKHPUR  Pediatric Inpatient Department (Pediatric IPD) and Pediatric Intensive Care Unit (PICU) Department of Pediatrics All India Institute of Medical Sciences (AIIMS) Gorakhpur Uttar Pradesh 273008 India
Gorakhpur
UTTAR PRADESH 		 6307847009

richasingh08014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Human Ethics Committee, AIIMS Gorakhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G409||Epilepsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1 Children diagnosed with paediatric epilepsy
2 Patients between the age of 6 and 15 years
3 Those who are willing to participate and provide informed consent from parents or guardians
 
 
ExclusionCriteria 
Details  1 Severe cognitive or developmental disabilities
affecting communication
2 Comorbid neurological or psychiatric disorders
such as autism severe intellectual disability
or psychosis
3 Patients who cannot communicate in English or
Hindi
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the impact of epilepsy on stigma, peer relationships, and health-related quality of life among children aged 6–15 years using standardized tools.
 		 Time Point
Baseline (single assessment at the time of enrolment) 
 
Secondary Outcome  
Outcome  TimePoints 
To explore the lived experiences of children with epilepsy regarding stigma, peer relationships, and quality of life through in-depth interviews.
 		 At the time of interview during hospital stay.
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/09/2025 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This study aims to assess and explore the impact of epilepsy on stigma, peer relationships, and health related quality of life among children aged 6 to 15 years. A sequential explanatory mixed method approach will be used. In the quantitative phase, data will be collected using standardized tools including the Epilepsy Self Stigma Scale, Peer Relationship Questionnaire, and Quality of Life in Childhood Epilepsy Questionnaire 16 (QOLCE 16). These tools will help measure the levels of self stigma, social interaction patterns, and overall quality of life in children with epilepsy. In the qualitative phase, in depth interviews will be conducted with selected participants to explore their lived experiences and perspectives related to stigma, peer support, and daily life challenges. The study seeks to generate evidence that can guide family, clinical, and community based interventions to support children living with epilepsy. 
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