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

NCT ID: NCT04959968

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-10

Study Completion Date

2023-06-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Craniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

eye patch and earplug

Intervention Type DEVICE

The use of eye patch and ear plugs in post-operative intensive care in craniotomy cases.

Control group

Standard care procedure will be applied to the control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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eye patch and earplug

The use of eye patch and ear plugs in post-operative intensive care in craniotomy cases.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taksim Egitim ve Arastirma Hastanesi

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gaziosmanpaşa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TaksimEğitim

Identifier Type: -

Identifier Source: org_study_id

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