The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients

Study Overview
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Brief Summary
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Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being, and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory disengagement from the external environment. Critically ill patients experience poor sleep quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many physiological, psychological and environmental factors contribute to the incidence of sleep disruption for the ICU patients. The primary physiologic factors documented in the literature are pain, medications and illness.The primary psychological factors documented in the literature are stress and worry. Environmental factors include noise, patient care activities and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of effective interventions like use of ear plugs and eye mask on decreasing light exposure and promoting sleep in ICU patients.

Detailed Description
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50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).

Official Title
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The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients

Conditions
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Sleep

Intervention / Treatment
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* Other: ear plug
* Other: eye mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years old. Mechanically ventilated patient. Conscious patient. No hearing problems. No eye disease. Not receiving narcotic drugs five to six hours before sleep time at night. No underlying disease that is affecting sleep such as rheumatoid arthritis and migraine. Exclusion Criteria Head injury. Psychiatric disease. Shocked patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Active Comparator: ear plug and eye mask<br>The patients will not receive the intervention in the first night (N1) from 9 pm to 6 am The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am. The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am. The patients will receive the intervention (eye mask and ear plug) in the fourth night (N4) from 9 pm to 6 am. | Other: ear plug<br>* The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.<br>* Other names: eastnova ear plug;Other: eye mask<br>* The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.<br>* Other names: Sleeping mask;|
| No Intervention: control<br>The researcher will assess and observe the patients who are receiving the routine hospital nursing care during the four nights. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality . | to assess sleep quality by using quality of sleep questionnaire or the Richards-Campbell Sleep Questionnaire (RCSQ) (measured by Units on a Scale) | four days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Melatonin | as urine Melatonin ( pg/mL) | four days | 
| Cortisol level | stress hormone as cortisol level (nmol/L) | four days | 
| Delirium assessment | Assessment of delirium by using NEECHAM confusion scale or Nursing delirium screening scale (measured by Units on a Scale) | four days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Ear Plug, Eye Mask, Mechanical ventilation, Sleep