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NCT Number: NCT07827248

The Effect of a Kolcaba's Comfort Theory-Based Educational Intervention on the Quality of Life of Patients With Epilepsy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ağrı Eğitim ve Araştırma Hastanesi

Ağrı, 04100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kolcaba Comfort Theory-Based Educational Program

Behavioral

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.

Other names: Kolcaba Comfort Theory-Based Educational Intervention, Epilepsy Education Program Based on Kolcaba Theory

Primary outcomes

  1. Quality of Life in Patients with Epilepsy (QOLIE-31)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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