The Effect of a Kolcaba's Comfort Theory-Based Educational Intervention on the Quality of Life of Patients With Epilepsy
2026年9月14日 更新者：Neşe Aykut、Ataturk University
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.
研究概览
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Neşe AYKUT
- 电话号码：+90 536 052 37 58
- 邮箱：naykut@agri.edu.tr
学习地点
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Ağrı
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Ağrı、Ağrı、土耳其（türkiye）、04100
- Ağrı Eğitim ve Araştırma Hastanesi
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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This intervention consists of a structured educational program based on Kolcaba's Comfort Theory.
The program is designed to improve comfort and quality of life in patients with epilepsy.
It includes planned educational sessions addressing physical, psychospiritual, sociocultural, and environmental comfort needs.
The education is delivered by the researcher in addition to routine clinical care.
其他名称：
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无干预：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Life in Patients with Epilepsy (QOLIE-31)
大体时间：Baseline and post-intervention (8-12 weeks)
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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.
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Baseline and post-intervention (8-12 weeks)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月30日
初级完成 (估计的)
2026年11月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年9月14日
首先提交符合 QC 标准的
2026年9月14日
首次发布 (实际的)
2026年9月18日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.