| 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
|
|
|
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
|
|
|
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. |