EpilepsyNCT07827248
The Effect of a Kolcaba's Comfort Theory-Based Educational Intervention on the Quality of Life of Patients With Epilepsy
A study testing Kolcaba Comfort Theory-Based Educational Program in people with Epilepsy, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Kolcaba Comfort Theory-Based Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ağrı Eğitim ve Araştırma Hastanesi
Ağrı, Ağrı, 04100
About this study
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
- Being tested
- Kolcaba Comfort Theory-Based Educational Program
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kolcaba Comfort Theory-Based Educational ProgramBehavioural
Also called Kolcaba Comfort Theory-Based Educational Intervention, Epilepsy Education Program Based on Kolcaba Theory
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention (8-12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neşe Aykut, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827248
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/952
- Other IDs
- TDK-2026-17230
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Kolcaba's Comfort Theory-Based Educational Intervention on the Quality of Life of Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT07827248
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/952
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Kolcaba Comfort Theory-Based Educational ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kolcaba Comfort Theory-Based Educational ProgramAlso: Kolcaba Comfort Theory-Based Educational Intervention, Epilepsy Education Program Based on Kolcaba TheoryThis 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. | Behavioural | Intervention Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kolcaba Comfort Theory-Based Educational Program in people with Epilepsy, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neşe AYKUT (+90 536 052 37 58, naykut@agri.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life in Patients with Epilepsy (QOLIE-31) (time frame: Baseline and post-intervention (8-12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.