- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07827248
The Effect of a Kolcaba's Comfort Theory-Based Educational Intervention on the Quality of Life of Patients With Epilepsy
14. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Neşe AYKUT
- Telefonnummer: +90 536 052 37 58
- E-mail: naykut@agri.edu.tr
Studiesteder
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Ağrı
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Ağrı, Ağrı, Tyrkiet (Türkiye), 04100
- Ağrı Eğitim ve Araştırma Hastanesi
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
Andre navne:
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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of Life in Patients with Epilepsy (QOLIE-31)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. september 2026
Primær færdiggørelse (Anslået)
1. november 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
14. september 2026
Først indsendt, der opfyldte QC-kriterier
14. september 2026
Først opslået (Faktiske)
18. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B.30.2.ATA.0.01.00/952
- TDK-2026-17230 (Andet bevillings-/finansieringsnummer: Ataturk University)
Plan for individuelle deltagerdata (IPD)
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