Comparing the Efficacy of Earplugs and Eye Masks on Pain and Sleep Quality

July 28, 2025 updated by: Esra Ozkan, Giresun University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Piraziz
      • Giresun, Piraziz, Turkey, 28000
        • Giresun Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
Device: Control Group
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.
Experimental: Earplug Group
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.
Device: Earplug Group
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.
Experimental: Eye mask Group
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.
Device: Eye mask Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative sleep quality
Time Frame: 6 month
Sleep quality was assessed using the Richard Campbell Sleep Questionnaire.
6 month
Postoperative pain severty
Time Frame: 6 month
Pain was assessed using the Visual Analyses Scale.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Giresun University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Giresun Üniversitesi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Control Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings