Cardiovascular Surgical ProceduresNCT06752980
The Effect of Eye Mask and Earplugs on Sleep Quality and Delirium in Coronary Artery Bypass Graft Patients: A Randomized Controlled Study
A study testing Eye mask, Earplugs and Eye Mask and Earplugs in people with Cardiovascular Surgical Procedures, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Cardiovascular Surgical Procedures
- What is being tested?
- Eye mask, Earplugs and Eye Mask and Earplugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Sep 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
zeliha Birer contact
Turkey (Türkiye)1 site
Necmettin Erbakan Universıty
Selçuklu, Konya, 42208
zeliha.birer.48@gmail.com
zeliha Birer
About this 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.
- Conditions
- Cardiovascular Surgical Procedures
- Being tested
- Eye mask, Earplugs, Eye Mask and Earplugs
- Keywords
- Cardiovascular surgical procedures, Delirium, Sleep
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye maskOther
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.
EarplugsOther
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 EarplugsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Eye Mask and Earplugs | Experimental | 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. |
| Earplugs | Experimental | 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. |
| Eye Mask | Experimental | 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. Receives: Other: Eye mask |
| no mask no earblugs | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.
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.
Measured: Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start7 Sep 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha Birer, Necmettin Erbakan University
- Investigators
- Saide Faydalı, Study director, Necmeetin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752980
- Sponsor's protocol ID
- NecmettinEU-SBF-ZB-01
- Status last verified
- Jun 2026
- First submitted
- 21 Dec 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eye Mask and Earplugs on Sleep Quality and Delirium in Coronary Artery Bypass Graft Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06752980
- Acronym / sponsor ID
- NecmettinEU-SBF-ZB-01
- Conditions
- Cardiovascular Surgical Procedures
- Keywords
- Cardiovascular surgical procedures, Delirium, Sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eye Mask and Earplugs | Experimental | –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. |
| Earplugs | Experimental | –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. |
| Eye Mask | Experimental | Other: Eye maskThe 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. |
| no mask no earblugs | No intervention | –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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -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
Key exclusion criteria (7 listed)
- • Patients diagnosed with sleep disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye maskThe 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. | Other | Eye Mask |
| EarplugsThe 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. | Other | – |
| Eye Mask and EarplugsThe 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. | Other | – |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 37138379Kilic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
zeliha Birer contact
Saide Faydalı study director
Necmeetin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye mask, Earplugs and Eye Mask and Earplugs in people with Cardiovascular Surgical Procedures, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saide Faydalı (+905056652357, sdfydl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06752980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.