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

NCT07827248 | Not Yet Recruiting

• 2 other identifiers: B.30.2.ATA.0.01.00/952TDK-2026-17230
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and post-intervention (8-12 weeks)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Kolcaba Comfort Theory-Based Educational Program

Control Group

NO INTERVENTION

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.

Interventions

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.

Also known as: Kolcaba Comfort Theory-Based Educational Intervention, Epilepsy Education Program Based on Kolcaba Theory

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ağrı Eğitim ve Araştırma Hastanesi

Ağrı, Ağrı, 04100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Neşe AYKUT

CONTACT

+90 536 052 37 58; naykut@agri.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

TU (1)