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NCT Number: NCT06752980

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan Universıty

Selçuklu, Konya, 42208, Turkey (Türkiye)

Location contact

zeliha Birer

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • • 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.

Treatment and study plan

Eye mask

Other

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.

Earplugs

Other

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.

Eye Mask and Earplugs

Other

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.

Primary outcomes

  1. Richards-Campbell Sleep Scale

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

    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.

  2. Nursing Delirium Screening Scale- Nu-DESC

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Saide Faydalı

CONTACT

[email protected]

+905056652357

zeliha Birer

CONTACT

+95308753846

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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