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临床试验/CTRI/2025/03/082997
CTRI/2025/03/082997已完成不适用

Impact of epilepsy and antiepileptic drugs on quality of life of children in a tertiary care hospital of coastal Karnataka

Neha Bindali1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年3月23日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
55 Questions categorized into 4 category which tell about the overall quality of life of children

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
4.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Patients between age of 4yrs-18yrs who have been under antiepileptic medicines for past 6 months.

排除标准

  • Patients with any physical and mental growth delay like ADHD, autism, GDD.

结局指标

主要结局

55 Questions categorized into 4 category which tell about the overall quality of life of children

时间窗: 4 weeks

次要结局

  • 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)

研究者

发起方
Neha Bindali
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Neha Bindali

Prasanna School of Public Health

研究点 (1)

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