Sleep QualityNCT07100002
Comparing the Efficacy of Earplugs and Eye Masks on Pain and Sleep Quality
A study testing Earplug Group and Eye mask Group in people with Sleep Quality and Pain, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
Objective: To determine the superiority of earplugs and eye masks to each other and their efficacy in pain and sleep quality. Methods: The study was a three-arm randomised controlled trial. After a baseline assessment, participants were randomly assigned in three groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality, Pain, Intensive Care Medicine
- What is being tested?
- Earplug Group and Eye mask Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and older,
- Having undergone first and elective cardiac surgery, literate, and having no verbal communication skills.
- The participants who stayed in the ICU for 48 hours after surgery, had an ASA (American Society of Anesthesiologists) Score of I or II, and had no visual or audial problems were also included in the study.
Who cannot join
- Exclusion criteria for the study participants were refusing to use an eye mask or earplug, having early complications or re-surgery history, having reintubation after extubation, having any intra-aortic balloon pump or cardiac pacemaker, and taking inotropic drugs in the ICU.
- Patients refusing to use an eye mask or earplugs were also excluded from the study. Additionally, patients who had a history of chronic pain, alcohol or drug dependency, psychiatric disease, chronic sleep disorders, anxiolytic or sleeping medication use, and claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Efficacy of Earplugs and Eye Masks on Pain and Sleep Quality in Cardiovascular Intensive Care Unit Patients: A Three-Arm Randomized Controlled Trial
Objective: To determine the superiority of earplugs and eye masks to each other and their efficacy in pain and sleep quality.
Methods: The study was a three-arm randomised controlled trial. After a baseline assessment, participants were randomly assigned in three groups. The random assignment was performed by using a computer program (Microsoft Excel 2016). Afterward, participants were categorized into three subgroups. Group 3 patients in this group did not receive any treatment to improve pain and sleep quality during the study period. Routine postoperative care was applied in the clinic (n = 25). Group 2 was applied the earplug (n = 25), whereas Group 1 was applied the eye mask (n = 24).
Read the detailed description
Cardiovascular diseases are among the most common and leading causes of death worldwide. Surgical methods such as coronary artery bypass graft surgery (CABG) provide successful results in this process. (1) Patients who are faced with these disturbing life-threatening experiences try to cope with many problems until the discharge process. The most common of these problems in the postoperative period is pain. Incision in the sternal region, saphenous vein grafting and the presence of chest and mediastinal tubes are reported to cause pain in patients following cardiac surgery (2,3) Pain is an inevitable condition for many patients after surgery. Inappropriate pain control leads to activation of the sympathetic nervous system and increased hormonal responses to stress. It may also lead to decreased patient satisfaction, delayed mobilization and increased risk of deep vein thrombosis and pulmonary thromboembolism (2) Inadequate pain management causes sleep deprivation, exhaustion and disorientation as well as agitation, which are common in critically ill patients (4,5).It has been reported that adult patients receiving treatment in the intensive care unit (ICU)often complain of difficulty sleeping or frequent awakenings (6). Excessive noise, bright lights, frequent medical procedures, routine monitoring of vital signs, invasive devices, medications, pain, and anxiety in the ICU contribute to a reduction in sleep quality (7,8). Many systematic reviews provide evidence that earplugs and eye masks impact sleep quality and the incidence of delirium. However, the literature highlights a lack of high-quality studies to confirm these findings (6,14). It was also determined that there were studies to determine the effect of eyemask and earplugs on sleep and pain level (10,11,12), however, there are no studies examining the superiority of earplugs or eye masks over each other. For this reason, the research was carried out to determine the superiority of earplugs and eye masks to each other.
- Conditions
- Sleep Quality, Pain, Intensive Care Medicine, Cardiac Surgery
- Being tested
- Control Group, Earplug Group, Eye mask Group
- Keywords
- Cardiac surgery, earplug, eye-mask, intensive care unit
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupDevice
Patients in this group did not receive any treatment to improve pain and sleep quality during the study period. Routine postoperative care was applied in the clinic.
Earplug GroupDevice
Patients who met the inclusion criteria were fitted with standard earplug of the same brand by the researcher at night. The researcher applied the earplug from 01:00 AM to 05:00 AM. The reason for this is that the procedures performed on the patients within the clinical routine ended at 01:00 AM and the patients' uninterrupted sleep hours coincided with these hours.
Eye mask GroupDevice
Patients who met the inclusion criteria were fitted with standard eye masks of the same brand by the researcher at night. The researcher applied the eye mask from 01:00 AM to 05:00 AM. The reason for this is that the procedures performed on the patients within the clinical routine ended at 01:00 AM and the patients' uninterrupted sleep hours coincided with these hours.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Device: Control Group |
| Earplug Group | Experimental | Patients who met the inclusion criteria were fitted with standard earplug of the same brand by the researcher at night. The researcher applied the earplug from 01:00 AM to 05:00 AM. The reason for this is that the procedures performed on the patients within the clinical routine ended at 01:00 AM and the patients' uninterrupted sleep hours coincided with these hours. Receives: Device: Earplug Group |
| Eye mask Group | Experimental | Patients who met the inclusion criteria were fitted with standard eye masks of the same brand by the researcher at night. The researcher applied the eye mask from 01:00 AM to 05:00 AM. The reason for this is that the procedures performed on the patients within the clinical routine ended at 01:00 AM and the patients' uninterrupted sleep hours coincided with these hours. Receives: Device: Eye mask Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative sleep quality
Sleep quality was assessed using the Richard Campbell Sleep Questionnaire.
Measured: 6 month
Postoperative pain severty
Pain was assessed using the Visual Analyses Scale.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Jan 2024
- Primary completion1 Jul 2024
- Study completion1 Jan 2025
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 Sleep QualityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Three-Arm Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ozkan, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100002
- Sponsor's protocol ID
- Giresun Üniversitesi
- Status last verified
- Jul 2025
- First submitted
- 22 Feb 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozkan E, Yaman Aktas Y, Surmeli S. Comparing the Efficacy of Earplugs and Eye Masks on Pain and Sleep Quality in Cardiovascular Intensive Care Unit Patients: A Three-Arm Randomised Controlled Trial. Nurs Crit Care. 2026 May;31(3):e70432. doi: 10.1111/nicc.70432.
PubMed 41920084
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Earplugs and Eye Masks on Pain and Sleep Quality in Cardiovascular Intensive Care Unit Patients: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07100002
- Acronym / sponsor ID
- Giresun Üniversitesi
- Conditions
- Sleep Quality, Pain, Intensive Care Medicine, Cardiac Surgery
- Keywords
- Cardiac surgery, earplug, eye-mask, intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 1 Aug 2025 (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.
Objective: To determine the superiority of earplugs and eye masks to each other and their efficacy in pain and sleep quality.
Methods: The study was a three-arm randomised controlled trial. After a baseline assessment, participants were randomly assigned in three groups. The random assignment was performed by using a computer program (Microsoft Excel 2016). Afterward, participants were categorized into three subgroups. Group 3 patients in this group did not receive any treatment to improve pain and sleep quality during the study period. Routine postoperative care was applied in the clinic (n = 25). Group 2 was applied the earplug (n = 25), whereas Group 1 was applied the eye mask (n = 24).
Detailed description
Cardiovascular diseases are among the most common and leading causes of death worldwide. Surgical methods such as coronary artery bypass graft surgery (CABG) provide successful results in this process. (1) Patients who are faced with these disturbing life-threatening experiences try to cope with many problems until the discharge process. The most common of these problems in the postoperative period is pain. Incision in the sternal region, saphenous vein grafting and the presence of chest and mediastinal tubes are reported to cause pain in patients following cardiac surgery (2,3) Pain is an inevitable condition for many patients after surgery. Inappropriate pain control leads to activation of the sympathetic nervous system and increased hormonal responses to stress. It may also lead to decreased patient satisfaction, delayed mobilization and increased risk of deep vein thrombosis and pulmonary thromboembolism (2) Inadequate pain management causes sleep deprivation, exhaustion and disorientation as well as agitation, which are common in critically ill patients (4,5).It has been reported that adult patients receiving treatment in the intensive care unit (ICU)often complain of difficulty sleeping or frequent awakenings (6). Excessive noise, bright lights, frequent medical procedures, routine monitoring of vital signs, invasive devices, medications, pain, and anxiety in the ICU contribute to a reduction in sleep quality (7,8). Many systematic reviews provide evidence that earplugs and eye masks impact sleep quality and the incidence of delirium. However, the literature highlights a lack of high-quality studies to confirm these findings (6,14). It was also determined that there were studies to determine the effect of eyemask and earplugs on sleep and pain level (10,11,12), however, there are no studies examining the superiority of earplugs or eye masks over each other. For this reason, the research was carried out to determine the superiority of earplugs and eye masks to each other.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A Three-Arm Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Control Group |
| Earplug Group | Experimental | Device: Earplug GroupPatients who met the inclusion criteria were fitted with standard earplug of the same brand by the researcher at night. The researcher applied the earplug from 01:00 AM to 05:00 AM. The reason for this is that the procedures performed on the patients within the clinical routine ended at 01:00 AM and the patients' uninterrupted sleep hours coincided with these hours. |
| Eye mask Group | Experimental | Device: Eye mask GroupPatients who met the inclusion criteria were fitted with standard eye masks of the same brand by the researcher at night. The researcher applied the eye mask from 01:00 AM to 05:00 AM. The reason for this is that the procedures performed on the patients within the clinical routine ended at 01:00 AM and the patients' uninterrupted sleep hours coincided with these hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 and older,
- Having undergone first and elective cardiac surgery, literate, and having no verbal communication skills.
- The participants who stayed in the ICU for 48 hours after surgery, had an ASA (American Society of Anesthesiologists) Score of I or II, and had no visual or audial problems were also included in the study.
Key exclusion criteria (2 listed)
- Exclusion criteria for the study participants were refusing to use an eye mask or earplug, having early complications or re-surgery history, having reintubation after extubation, having any intra-aortic balloon pump or cardiac pacemaker, and taking inotropic drugs in the ICU.
- Patients refusing to use an eye mask or earplugs were also excluded from the study. Additionally, patients who had a history of chronic pain, alcohol or drug dependency, psychiatric disease, chronic sleep disorders, anxiolytic or sleeping medication use, and claustrophobia.
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 |
|---|---|---|
| Control GroupPatients in this group did not receive any treatment to improve pain and sleep quality during the study period. Routine postoperative care was applied in the clinic. | Device | Control Group |
| Earplug GroupPatients who met the inclusion criteria were fitted with standard earplug of the same brand by the researcher at night. The researcher applied the earplug from 01:00 AM to 05:00 AM. The reason for this is that the procedures performed on the patients within the clinical routine ended at 01:00 AM and the patients' uninterrupted sleep hours coincided with these hours. | Device | Earplug Group |
| Eye mask GroupPatients who met the inclusion criteria were fitted with standard eye masks of the same brand by the researcher at night. The researcher applied the eye mask from 01:00 AM to 05:00 AM. The reason for this is that the procedures performed on the patients within the clinical routine ended at 01:00 AM and the patients' uninterrupted sleep hours coincided with these hours. | Device | Eye mask Group |
Primary outcome
Postoperative sleep quality
Time frame: 6 month
Sleep quality was assessed using the Richard Campbell Sleep Questionnaire.
Postoperative pain severty
Time frame: 6 month
Pain was assessed using the Visual Analyses Scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Derived from this study: PubMed 41920084Ozkan E, Yaman Aktas Y, Surmeli S. Comparing the Efficacy of Earplugs and Eye Masks on Pain and Sleep Quality in Cardiovascular Intensive Care Unit Patients: A Three-Arm Randomised Controlled Trial. Nurs Crit Care. 2026 May;31(3):e70432. doi: 10.1111/nicc.70432.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Earplug Group and Eye mask Group in people with Sleep Quality and Pain, run by Giresun 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative sleep quality (time frame: 6 month). 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 NCT07100002, 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 1 Aug 2025.