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

NCT07100002 | Completed

• 1 other identifier: Giresun Üniversitesi
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep Quality; Pain; Intensive Care Medicine; Cardiac Surgery

Keywords

Cardiac surgery, earplug, eye-mask, intensive care unit

Outcome Measures

Primary Outcomes (2)

• Postoperative sleep quality

  Sleep quality was assessed using the Richard Campbell Sleep Questionnaire.

  6 month

• Postoperative pain severty

  Pain was assessed using the Visual Analyses Scale.

  6 month

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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.

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.

Device: Eye mask Group

Interventions

Control Group DEVICE

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.

Control Group

Earplug Group DEVICE

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.

Earplug Group

Eye mask Group DEVICE

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.

Eye mask Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun Universitesi

Giresun, Piraziz, 28000, Turkey (Türkiye)

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Model Details: A Three-Arm Randomized Controlled Trial

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: August 1, 2025
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

TU (1)