- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nilgün SÖYLEMEZ, PhD
- Phone Number: +905439790424
- Email: nilgunsoylemez@munzur.edu.tr
Study Locations
-
-
Erzurum
-
Erzurum, Erzurum, Turkey (Türkiye), 25040
- Ataturk University Research Hospital
-
Contact:
- Nilgün SÖYLEMEZ, PhD
- Phone Number: +905439790424
- Email: nilgunsoylemez@munzur.edu.tr
-
Principal Investigator:
- Beyzanur KIZILOĞLU AĞGÜN, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
A light-blocking eye mask will be used during nighttime sleep to reduce exposure to ambient light and support sleep.
|
|
No Intervention: Control Group
Participants in this group will receive routine postoperative care without the use of an eye mask.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Sleep Quality Assessed Using the Richards-Campbell Sleep Questionnaire
Time Frame: Postoperative day 5, postoperative day 7, and the day of hospital discharge(postoperative day 8-10)
|
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.
|
Postoperative day 5, postoperative day 7, and the day of hospital discharge(postoperative day 8-10)
|
|
Postoperative Delirium Assessed Using the Nursing Delirium Screening Scale
Time Frame: 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)
|
Postoperative day 5, postoperative day 7, and the day of hospital discharge (postoperative day 8-10)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Heart Diseases
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Ischemia
- Delirium
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Emergence Delirium
- Sleep Initiation and Maintenance Disorders
- Coronary Artery Disease
Other Study ID Numbers
- EYEMASK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.