The Effect of a Kolcaba's Comfort Theory-Based Educational Intervention on the Quality of Life of Patients With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of Life in Patients with Epilepsy (QOLIE-31)
研究概览
简要总结
This study is a two-arm controlled interventional study designed to evaluate the effect of a Kolcaba's Comfort Theory-based educational intervention on the quality of life of patients with epilepsy. Eligible participants will be assigned to either an intervention group or a control group. Participants in the intervention group will receive a structured educational program developed according to the principles of Kolcaba's Comfort Theory in addition to routine care, whereas participants in the control group will receive routine care only. Quality of life assessments will be conducted at baseline and after the intervention period using validated measurement instruments. The primary objective is to determine whether the theory-based educational intervention improves the quality of life of patients with epilepsy compared with routine care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 years of age or older
- •Having a diagnosis of epilepsy for at least 6 months
- •Being able to read and write in Turkish
- •Having access to a reachable telephone for communication
- •Clinical diagnosis and hospital records will be used to confirm eligibility criteria, along with participant self-report
排除标准
- •Presence of psychiatric disorders affecting cognitive processes (e.g., dementia, schizophrenia)
- •Having chronic diseases other than epilepsy
- •Being pregnant
- •Willingness to withdraw from the study at any stage
研究组 & 干预措施
Intervention Group
Participants in the intervention group will receive a structured educational program based on Kolcaba's Comfort Theory in addition to routine clinical care. The education will be delivered through planned sessions focusing on improving comfort, self-management, and quality of life in patients with epilepsy. The content includes physical, psychospiritual, sociocultural, and environmental comfort dimensions.
干预措施: Kolcaba Comfort Theory-Based Educational Program (Behavioral)
Control Group
Participants in the control group will receive routine clinical care only. No structured educational intervention will be provided during the study period. Outcomes will be assessed at baseline and after the study period using the same measurement tools as the intervention group.
结局指标
主要结局
Quality of Life in Patients with Epilepsy (QOLIE-31)
时间窗: Baseline and post-intervention (8-12 weeks)
The primary outcome is the quality of life of patients with epilepsy. Quality of life will be assessed using a validated epilepsy-specific quality of life scale before and after the Kolcaba Comfort Theory-based educational intervention. Changes in quality of life scores between baseline and post-intervention measurements will be analyzed.
次要结局
未报告次要终点
研究者
Neşe Aykut
PhD Student
Ataturk University