The Effect of Eye Masks and Earplugs In Intensive Care Unit Patients

November 5, 2024 updated by: onur çetinkaya, PhD, Osmaniye Korkut Ata University

The Effect of Eye Masks and Earplugs on Sleep Quality and Life Findings In Intensive Care Unit Patients

This study was planned as a randomized controlled and experimental study to evaluate the effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research will be conducted with 60 patients hospitalized in the intensive care units of a state hospital. Research data will be collected with a questionnaire, vital signs follow-up form, insomnia severity index, and Richards-Campbell Sleep Quality Scale. Patients will be divided into intervention and control groups. Eye mask and ear plugs will be applied to the intervention group for 3 days, and the control group will receive routine care. The study will be terminated after 3 days of follow-up for each patient.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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
    • Merkez
      • Osmaniye, Merkez, Turkey, 80000
        • Osmaniye Public Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years and over,
  • Able to answer all questions and communicate,
  • Those who agreed to participate in the research
  • Being in the category of insomnia, moderate insomnia, or severe insomnia according to the insomnia severity index,
  • Not sedating
  • Not connected to a ventilator
  • No hearing problem
  • Glasgow Coma Score of 15

Exclusion Criteria:

  • Connecting to the ventilator during operation
  • Sedation during the study
  • Wanting to leave the research during the study
  • Being in the intervention group and removing the eye patch or earplug during sleep
  • GCS falling below 15

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No application will be made to the participants. Participants will receive routine care.
Other: intervention group
In addition to routine care, participants will be given eye masks and ear plugs for 3 days.
Other: Eye masks and ear plugs
Eye masks and ear plugs will be applied to patients for 3 days between 22:00 and 06:00.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal questionnaire
Time Frame: Only one times. At the first meeting (up to one day).
It is a form consisting of 22 questions in order to investigate the sociodemographic characteristics and health status of the patients.
Only one times. At the first meeting (up to one day).
Vital signs follow-up form
Time Frame: up to 3 days
It will be used to measure patients' fever, pulse, respiration, blood pressure and sPO2 values. It will be applied to patients at 22, 02, 06 hours. Also, the daily average hour will be calculated at the end of each day.
up to 3 days
Insomnia Severity Index
Time Frame: up to 3 days
It will be used to measure the severity of insomnia in patients. It consists of 7 questions and each question can receive points between 0 and 4. A maximum score of 28 and a minimum score of 0 are obtained on the scale, and as the score increases, the severity of insomnia increases.
up to 3 days
Richards-Campbell Sleep Scale
Time Frame: up to 3 days
The scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.
up to 3 days

Collaborators and Investigators

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

Sponsor

Osmaniye Korkut Ata University

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)

September 1, 2023

Primary Completion (Actual)

January 15, 2024

Study Completion (Actual)

January 16, 2024

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OKU-SHMYO-OC-01

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 Sleep Quality

Clinical Trials on Eye masks and ear plugs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe