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

Study Overview
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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.

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

Conditions
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Sleep Quality, Vital Signs

Intervention / Treatment
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* Other: Eye masks and ear plugs


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial with control and intervention groups
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal questionnaire | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep quality, vital signs, intensive care, ear plugs, eye masks