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Not yet recruitingNCT06752980Updated Jun 17, 2026

The Effect of Eye Mask and Earplugs on Sleep Quality and Delirium in Coronary Artery Bypass Graft Patients: A Randomized Controlled Study

An interventional study of Eye mask and Earplugs in Cardiovascular Surgical Procedures, sponsored by Necmettin Erbakan University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by Necmettin Erbakan University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

Coronary artery bypass grafting is the most commonly performed surgical procedure among cardiovascular diseases. Nursing care for patients undergoing cardiac surgery involves a process that includes preoperative preparation and subsequent close monitoring of neurological, cardiac, respiratory, vascular status, kidney function, and pain. Sleep disturbances are observed after cardiac surgery. Sleep plays a critical role in the body's maintenance, repair, and renewal processes. Improved sleep can reduce patient agitation and decrease the risk of delirium. The presence of delirium leads to increased care requirements and prolonged hospital stays, which in turn raises hospital costs. Enhancing sleep quality and preventing delirium after surgery have positive effects on clinical patient outcomes. This study is designed to determine the effects of using eye masks and/or earplugs on sleep quality and delirium in patients undergoing coronary artery bypass grafting during nighttime sleep. This research is a randomized controlled clinical trial.

02

Conditions studied

  • Cardiovascular Surgical Procedures

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Keywords

  • Cardiovascular surgical procedures, Delirium, Sleep
03

In context

Delirium

933 studies on the registry are indexed under Delirium; 190 are open to participants now.

This study's planned enrollment of 128 is above the median of 112 across 550 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Necmettin Erbakan University is the lead sponsor of 201 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-Patients who voluntarily agree to participate in the study

  • Those who have undergone coronary artery bypass graft surgery
  • Those between the ages of 18-79
  • Those who are cooperative and oriented
  • Those who are literate
  • Those who speak Turkish
  • Those whose initial delirium scale score (Nu-DECS) is less than 2
  • Those whose Glasgow coma scale score is >13 will be included in the study.

Exclusion criteria

Exclusion Criteria:

    • Patients diagnosed with sleep disorders,

      • Those using sleeping pills,
      • Those who have a habit of using an eye patch while sleeping,
      • Those who were not transferred to the clinic on the first day after surgery and whose treatment continues in the intensive care unit,
      • Those who develop complications and/or need to be re-operated,
      • Those who need treatment other than routine treatment,
      • Patients with hearing or vision problems will be excluded.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    Eye Mask and Earplugs

    On the 1st, 2nd and 3rd postoperative day, the experimental group will be given the intervention reserved during their night sleep, using eye patches and earplugs. On the 2nd, 3rd and 4th postoperative day, repeated monitoring will be performed using RCUÖ and Nu-DESC. Patients who wish to leave the study at any stage, do not receive the reserved intervention or die during the monitoring will be excluded from the study.

  • Experimental
    Earplugs

    The reserved intervention will be applied during the night sleep with earplugs on the 1st, 2nd and 3rd day group after the surgery. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after the surgery. Patients who want to leave at any stage of the study, do not receive the reserved intervention or die during the monitoring will be excluded from the study.

  • Experimental
    Eye Mask

    The intervention allocated during night sleeps with Eye Mask applied on the 1st, 2nd and 3rd days after the surgery will be applied. Repeated monitoring will be done using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after the surgery. Patients who want to leave at any stage of the study, do not perform the allocated intervention or die during the follow-up will be excluded from the study.

    Other: Eye mask

  • No intervention
    no mask no earblugs

    No intervention will be performed on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed on the 2nd, 3rd and 4th postoperative day using RCUÖ and Nu-DESC. Patients who wish to leave the study at any stage, who do not perform the intervention, or who die during follow-up will be excluded from the study.

Interventions

  • OtherEye mask

    The three experimental groups (eye patch group, earplug group, eye patch and earplug group applied together) will be given a separate intervention during their night sleep on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th postoperative days.

  • OtherEarplugs

    The three experimental groups (eye patch group, earplug group, eye patch and earplug group applied together) will be given a separate intervention during their night sleep on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th postoperative days.

  • OtherEye Mask and Earplugs

    The three experimental groups (eye patch group, earplug group, eye patch and earplug group applied together) will be given a separate intervention during their night sleep on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th postoperative days.

06

What researchers measure

Primary outcomes

  1. Richards-Campbell Sleep Scale

    The RCUS was developed by Richards and colleagues (1987) to assess sleep. The RCUS includes six items (sleep depth, time to fall asleep, frequency of awakenings, time to remain awake when awakened, quality of sleep, and ambient noise level). Each item is rated using a 0-100 visual analog scale. The total score is obtained by dividing the individual items by their numbers: 0 represents the worst sleep, 100 the best sleep. As the score obtained from the scale increases, the sleep quality of the patients also increases. The RCUS provides a short, applicable, comprehensive, and simple tool for assessing sleep quality in the intensive care unit and is the most common. The Cronbach α value of the scale was found to be 0.82. The validity and reliability study of the scale in our country was conducted by Karaman Özlü and Özer (2015). The Cronbach Alpha internal consistency coefficient of the scale was found to be 0.91.

    Time frame: Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.

  2. Nursing Delirium Screening Scale- Nu-DESC

    The scale consists of five items. These are; disorientation, inappropriate behavior, inappropriate communication, illusion-hallucination and slowness in psychomotor behavior. It is critical that all subtypes can be detected in an effective delirium diagnosis. Among the items in Nu-DESC, it is thought that hypoactive delirium is detected more successfully with the item that evaluates psychomotor slowness. Each item in the scale takes a value between 0 and 2 points and the total score varies between 0 and 10. Two points and above indicate delirium. The evaluation time is approximately one minute.

    Time frame: Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.

07

Study locations

1 site
  • Necmettin Erbakan Universıty
    Selçuklu, Konya 42208, Turkey (Türkiye)
08

References and documents

Publications

  • Kilic G, Kav S. Effect of using eye masks and earplugs in preventing delirium in intensive care patients: A single-blinded, randomized, controlled trial. Nurs Crit Care. 2023 Sep;28(5):698-708. doi: 10.1111/nicc.12901. Epub 2023 May 3. PubMed 37138379 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06752980
Responsible party
Zeliha Birer (Nurse, Necmettin Erbakan University) — Principal investigator
First posted
Dec 31, 2024
Start date
Sep 7, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Jun 17, 2026

Study contacts

Saide Faydalı
Contact
sdfydl@gmail.com
+905056652357
zeliha Birer
Contact
+95308753846
Saide Faydalı
study director · Necmeetin Erbakan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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