MedTrace Logo

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

NCT07100002 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-08-01

No results posted yet for this study

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Giresun University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-07-01
Completion
2025-01-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100002 on ClinicalTrials.gov