- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Nilgün SÖYLEMEZ, PhD
- Telefonnummer: +905439790424
- E-post: nilgunsoylemez@munzur.edu.tr
Studieorter
-
-
Erzurum
-
Erzurum, Erzurum, Turkiet (Türkiye), 25040
- Ataturk University Research Hospital
-
Kontakt:
- Nilgün SÖYLEMEZ, PhD
- Telefonnummer: +905439790424
- E-post: nilgunsoylemez@munzur.edu.tr
-
Huvudutredare:
- Beyzanur KIZILOĞLU AĞGÜN, PhD
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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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Inget ingripande: Control Group
Participants in this group will receive routine postoperative care without the use of an eye mask.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative Sleep Quality Assessed Using the Richards-Campbell Sleep Questionnaire
Tidsram: 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
Tidsram: Postoperative day 5, postoperative day 7, and the day of hospital discharge (postoperative day 8-10)
|
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)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Mentala störningar
- Postoperativa komplikationer
- Patologiska processer
- Hjärtsjukdom
- Förvirring
- Neurobehavioral manifestationer
- Neurokognitiva störningar
- Vakna sömnstörningar
- Sömnstörningar, inneboende
- Dyssomni
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Kranskärlssjukdom
- Myokardischemi
- Delirium
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Emergence Delirium
- Sömninitiering och underhållsstörningar
- Kranskärlssjukdom
Andra studie-ID-nummer
- EYEMASK
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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