NCT07768020

Brief Summary

Coronary artery bypass graft (CABG) surgery is an effective treatment for coronary artery disease; however, sleep disturbances and delirium are common during the postoperative period and may adversely affect recovery. Environmental factors, particularly light exposure, can disrupt the sleep-wake cycle and contribute to poor sleep quality. Eye masks offer a simple, safe, and non-pharmacological method of reducing light exposure and supporting sleep. This study aims to determine the effect of eye mask use on sleep quality and delirium levels in patients following CABG surgery.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

August 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 6, 2026

Last Update Submit

August 11, 2026

Conditions

Keywords

Coronary Artery Bypass GraftingEye MaskSleep QualityPostoperative DeliriumCardiac SurgeryNon-Pharmacological InterventionPostoperative Nursing Care

Outcome Measures

Primary Outcomes (2)

  • Postoperative Sleep Quality Assessed Using the Richards-Campbell Sleep Questionnaire

    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

    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)

Study Arms (2)

Eye Mask Group

EXPERIMENTAL

Participants in this group will wear an eye mask during nighttime sleep following coronary artery bypass graft surgery in addition to routine postoperative care.

Other: Eye Mask

Control Group

NO INTERVENTION

Participants in this group will receive routine postoperative care without the use of an eye mask.

Interventions

A light-blocking eye mask will be used during nighttime sleep to reduce exposure to ambient light and support sleep.

Eye Mask Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Research Hospital

Erzurum, Erzurum, 25040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery DiseaseSleep Initiation and Maintenance DisordersEmergence Delirium

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive Disorders

Central Study Contacts

Nilgün SÖYLEMEZ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PhD, Department of Surgical Nursing

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 17, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

August 17, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations