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

NCT ID: NCT05970614

Last Updated: 2024-11-07

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

2023-09-01

Study Completion Date

2024-01-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Quality Vital Signs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial with control and intervention groups
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Only participants were blinded in the study.

Study Groups

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Control group

No application will be made to the participants. Participants will receive routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention group

In addition to routine care, participants will be given eye masks and ear plugs for 3 days.

Group Type OTHER

Eye masks and ear plugs

Intervention Type OTHER

Eye masks and ear plugs will be applied to patients for 3 days between 22:00 and 06:00.

Interventions

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Eye masks and ear plugs

Eye masks and ear plugs will be applied to patients for 3 days between 22:00 and 06:00.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osmaniye Korkut Ata University

OTHER

Sponsor Role lead

Responsible Party

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onur çetinkaya, PhD

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Osmaniye Public Hospital

Osmaniye, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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OKU-SHMYO-OC-01

Identifier Type: -

Identifier Source: org_study_id

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