The Use of Eye Patches and Earplugs in Intensive Care in Cases of Craniotomy.

August 16, 2023 updated by: Taksim Egitim ve Arastirma Hastanesi

The Effect of Use of Eye Bands and Earplugs on Sleep Quality, Anxiety and Comfort Level in Patients Undergoing Craniotomy Surgery

This study aims to evaluate the effects of using eye patch and earplugs on anxiety, patient comfort, and sleep quality after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed as a non-drug clinical study with 2 randomly selected groups to evaluate the effect of eye patch and earplug use on sleep quality, anxiety and comfort level in patients hospitalized in the intensive care unit after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.

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
      • Istanbul, Turkey
        • Gaziosmanpaşa Training and Research 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients scheduled for elective craniotomy and intensive care for at least 48 hours
  • Glasgow Coma Scale score = 15
  • Turkish literate

Exclusion Criteria:

  • Diagnosis of sleep disorder
  • Hearing and/or vision loss
  • Hearing aid use
  • Pregnant women
  • Communication and/or cooperation problem
  • Chronic pain medication

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
Intervention / Treatment
Experimental: Intervention group
An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00
Device: eye patch and earplug
The use of eye patch and ear plugs in post-operative intensive care in craniotomy cases.
No Intervention: Control group
Standard care procedure will be applied to the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Richards-Campbell Sleep Questionnaire
Time Frame: On the 1 day of craniotomy
Sleep quality levels of the craniotomy cases
On the 1 day of craniotomy
The Richards-Campbell Sleep Questionnaire
Time Frame: Post-operative second day of craniotomy
Sleep quality levels of the craniotomy cases
Post-operative second day of craniotomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Hospital Anxiety and Depression Scale
Time Frame: On the 1 day of craniotomy
Anxiety levels of the craniotomy cases
On the 1 day of craniotomy
The Hospital Anxiety and Depression Scale
Time Frame: Post-operative second day of craniotomy
Anxiety levels of the craniotomy cases
Post-operative second day of craniotomy
The General Comfort Questionnaire
Time Frame: Post-operative second day of craniotomy
General comfort levels of the craniotomy cases
Post-operative second day of craniotomy

Collaborators and Investigators

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

Sponsor

Taksim Egitim ve Arastirma Hastanesi

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)

July 10, 2021

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

June 17, 2023

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TaksimEğitim

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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