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CTRI Number  CTRI/2025/03/082997 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the Impact of Epilepsy and Its Treatment on Childrens Lives in Coastal Karnataka 
Scientific Title of Study   Impact of epilepsy and antiepileptic drugs on quality of life of children in a tertiary care hospital of coastal Karnataka 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Bindali 
Designation  student 
Affiliation  Prasanna School of Public Health 
Address  Department of Healthcare and Hospital Management, No division room LH 3, Tiger circle road, Madhav Nagar, Manipal, Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  8296025260  
Fax    
Email  neha1.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Khamat 
Designation  Assistant Professor- Senior Scale 
Affiliation  Manipal Academy of Higher education  
Address  Department of Healthcare and Hospital Management, No division room ,65CADEMY Tiger circle road, Madhav Nagar, Manipal, Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  7760218342  
Fax    
Email  rajeshkamath82@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Khamat 
Designation  Assistant Professor- Senior Scale 
Affiliation  Manipal Academy of Higher education  
Address  Department of Healthcare and Hospital Management, No division room ,65CADEMY Tiger circle road, Madhav Nagar, Manipal, Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  7760218342  
Fax    
Email  rajeshkamath82@gmail.com  
 
Source of Monetary or Material Support  
Assessing impact of epilepsy on quality of life of children is conducted infrastructural provided by Kasturba Hospital, Manipal, Karnataka 576104, India  
 
Primary Sponsor  
Name  Neha Bindali  
Address  Tiger circle road, Madhav Nagar, Manipal India 576104 
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 
Dr Rajesh Kamath  Kasturba Hospital, Manipal Karnataka 576104, India  Department of Pediatrics, Women and Child block. Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA 
7760218342

rajeshkamath82@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College Kasturba Hospital Institutional Ethics Committee-2  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 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Patients between age of 4yrs-18yrs who have been under antiepileptic medicines for past 6 months 
 
ExclusionCriteria 
Details  Patients with any physical and mental growth delay like ADHD, autism, GDD 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
55 Questions categorized into 4 category which tell about the overall quality of life of children  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Critical determinants of quality of life will be identified, including seizure characteristics, AED adherence, family dynamics, and psychosocial factors such as anxiety and depression.   2 weeks 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "88"
Final Enrollment numbers achieved (India)="88" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/03/2025 
Date of Study Completion (India) 15/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/04/2025 
Estimated Duration of Trial   Years="0"
Months="0"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

This six-month cross-sectional observational study aims to assess the quality of life (QOL) in children with epilepsy (CWE) and explore the influence of sociodemographic factors on their overall well-being. The study is conducted at a tertiary care teaching hospital in coastal Karnataka, with participants aged 4–18 years who have been diagnosed with epilepsy and on treatment for at least six months. Children with intellectual disabilities, developmental delays, or other chronic conditions are excluded. Using non-probability sampling, data will be collected through the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55), which evaluates cognitive, emotional, social, and physical aspects of QOL. The study aims to assess the quality of life in CWE, examine the relationship between sociodemographic factors (such as gender, parental education, and socioeconomic status) and QOL, and identify key predictors of QOL that can guide clinical and social interventions for improving their overall well-being. Statistical analysis will be performed using Spearman correlation, Chi-square tests, t-tests, ANOVA, and multivariable regression to determine significant associations. Ethical considerations include Institutional Ethics Committee (IEC) approval, ensuring patient confidentiality and adherence to ethical guidelines. The findings from this study are expected to provide valuable insights into the social determinants of QOL in CWE, helping develop targeted interventions, healthcare policies, and support systems for affected children and their families in India.

 
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