Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care Patients

Study Overview
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Brief Summary
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This study was conducted as a pre-test and post-test randomized controlled single center study to evaluate the effect of ear plugs and eye mask application on sleep quality in patients hospitalized in the intensive care unit. 120 patients who received inpatient treatment in Siirt State Hospital general intensive care unit constitute the sample of the study. The sample consist of four groups: ear plug group (n=30), eye mask group (n=30), earplug-eye mask group (n=30) and control group (n=30). Data were collected using the Patient Identification Form, Glasgow Coma Skale, Visual Analog Scale, Richards-Campbell Sleep Questionnaire (RCSQ), ear plug and eye mask. As a preliminary test, RCSQ was applied in the morning of the second day after the first night sleep of the patients. Then, according to the group they were assigned to, the patients were allowed to sleep by applying only ear plug, eye mask only and simultaneous ear plug-eye mask between 22:00-06:00. As a final test, RCSQ was readministered to patients on the morning of the third day after the second night's sleep. During the analysis of the data, frequency, number, mean, Student t test and/or Mann- Whitney U test, ANOVA and/or Kruskal- Wallis test, t test or Wilcoxon Sign test, chi-square test were used.

Official Title
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Evaluation of the Effect of Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care patıents: Randomized Controlled Study

Conditions
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Sleep Quality

Intervention / Treatment
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* Other: eye mask and ear plug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being 18 years or older Being literate No hearing impairment Ability to communicate verbally Receiving inpatient treatment in the GICU for at least 3 days Have 15 Glasgow Coma Scale (GCS) scores (Minimum scores will be as follows. 3 points from eye response; 5 points from motor response; 2 points from verbal response) Agreeing to participate in the research Exclusion Criteria: Having a Visual Analog Scale (VAS) score above 7 Using sleeping pills or sedative drugs Being treated with a diagnosis of sleep disorder Being on mechanical ventilation Having an active ear or eye infection Having a diagnosed psychiatric illness

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ear plug group<br> | Other: eye mask and ear plug<br>* black eye mask and silicon ear plug<br>|
| Experimental: Eye mask group<br> | Other: eye mask and ear plug<br>* black eye mask and silicon ear plug<br>|
| Experimental: Eye mask+Ear plug group<br> | Other: eye mask and ear plug<br>* black eye mask and silicon ear plug<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Richards Campbell Sleep Scale | RCSS is a six-item scale that evaluates the depth of night sleep, the time to fall asleep, the frequency of waking, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. | Three day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | The scale developed by Price et al. in 1983 measures the severity of the patient's pain. | Three day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing, intensive care unit, ear plug, eye mask, sleep quality