- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07768020
Effect of Eye Mask Use on Sleep Quality and Delirium After CABG Surgery (EYE-CABG)
The Effect of Eye Mask Use on Sleep Quality and Delirium Levels in Patients Following Coronary Artery Bypass Graft Surgery
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Patients undergoing coronary artery bypass graft surgery may experience substantial disruption of their normal sleep-wake cycle during the postoperative period. Physical symptoms such as pain, dyspnea, and nocturia; psychological factors such as anxiety and depression; and environmental factors such as noise and continuous light exposure may contribute to poor sleep. Disrupted sleep may delay recovery, reduce quality of life, and increase susceptibility to postoperative delirium.
Non-pharmacological interventions are increasingly used to promote sleep while avoiding medication-related adverse effects. Reducing ambient light during nighttime sleep may support circadian regulation and facilitate sleep initiation and maintenance. Eye masks provide a simple, safe, inexpensive, and readily applicable method of limiting light exposure in clinical settings.
This study will evaluate whether postoperative eye mask use improves sleep quality and reduces delirium levels in patients undergoing coronary artery bypass graft surgery. The findings may provide evidence for incorporating eye mask use into routine postoperative nursing care following cardiac surgery.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Nilgün SÖYLEMEZ, PhD
- Telefonnummer: +905439790424
- E-post: nilgunsoylemez@munzur.edu.tr
Studiesteder
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Erzurum
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Erzurum, Erzurum, Tyrkia (Türkiye), 25040
- Ataturk University Research Hospital
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Ta kontakt med:
- Nilgün SÖYLEMEZ, PhD
- Telefonnummer: +905439790424
- E-post: nilgunsoylemez@munzur.edu.tr
-
Hovedetterforsker:
- Beyzanur KIZILOĞLU AĞGÜN, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Aged 18 years or older
- Scheduled to undergo elective coronary artery bypass graft surgery
- Conscious, cooperative, and oriented
- No diagnosed cognitive impairment that would prevent informed consent or completion of the study assessments
- Able to communicate in Turkish
- Baseline Nursing Delirium Screening Scale (Nu-DESC) score below 2
- Able and willing to use an eye mask
- Voluntarily agreed to participate and provided written informed consen
Exclusion Criteria:
- Diagnosed sleep disorder
- Regular use of sleep medication
- Habitual use of an eye mask during sleep
- Severe visual impairment or an ocular, facial, or skin condition preventing the safe use of an eye mask
- Severe communication impairment preventing completion of the data collection instruments
- Undergoing emergency coronary artery bypass graft surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Eye Mask Group
Participants in this group will wear an eye mask during nighttime sleep following coronary artery bypass graft surgery in addition to routine postoperative care.
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A light-blocking eye mask will be used during nighttime sleep to reduce exposure to ambient light and support sleep.
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Ingen inngripen: Control Group
Participants in this group will receive routine postoperative care without the use of an eye mask.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Sleep Quality Assessed Using the Richards-Campbell Sleep Questionnaire
Tidsramme: Postoperative day 5, postoperative day 7, and the day of hospital discharge(postoperative day 8-10)
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Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire.
The total score ranges from 0 to 100, with higher scores indicating better sleep quality.
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Postoperative day 5, postoperative day 7, and the day of hospital discharge(postoperative day 8-10)
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Postoperative Delirium Assessed Using the Nursing Delirium Screening Scale
Tidsramme: Postoperative day 5, postoperative day 7, and the day of hospital discharge (postoperative day 8-10)
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Postoperative delirium will be assessed using the Nursing Delirium Screening Scale (Nu-DESC).
The scale consists of five items, each scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater delirium severity, and a total score of 2 or higher indicates the presence of delirium.Postoperative day 5, postoperative day 7, and the day of hospital discharge (postoperative day 8-10)
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Postoperative day 5, postoperative day 7, and the day of hospital discharge (postoperative day 8-10)
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Psykiske lidelser
- Postoperative komplikasjoner
- Patologiske prosesser
- Hjertesykdommer
- Forvirring
- Nevroatferdsmanifestasjoner
- Nevrokognitive lidelser
- Søvnvåkenforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Arteriosklerose
- Arterielle okklusive sykdommer
- Koronar sykdom
- Myokardiskemi
- Delirium
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Emergence Delirium
- Søvninitiering og vedlikeholdsforstyrrelser
- Koronararteriesykdom
Andre studie-ID-numre
- EYEMASK
Plan for individuelle deltakerdata (IPD)
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