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

Not Applicable

Completed

• Conditions: Sleep Quality; Pain; Intensive Care Medicine; Cardiac Surgery

• Registration Number: NCT07100002
• Lead Sponsor: Giresun University

Brief 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. 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 Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-07-01
• Study Completion: 2025-01-01
• Study First Submitted: 2025-02-22
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative sleep quality	6 month	Sleep quality was assessed using the Richard Campbell Sleep Questionnaire.
Postoperative pain severty	6 month	Pain was assessed using the Visual Analyses Scale.

Trial Locations

Locations (1)

Giresun Universitesi; 🇹🇷 Giresun, Piraziz, Turkey