The Effect of Applying Multidisciplinary Bundle Intervention on the Delirium Incidence in Critically Ill Patients

Study Overview
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Brief Summary
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The patients will exposed to different intervention through three nights (ear plug, eye mask). 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).

Detailed Description
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The multicomponent bundle of interventions is designed to be multidisciplinary, and included measures taken to reduce noise, light and iatrogenic sleep disturbance, as well as attempts to modify risk factors for delirium. The patients will exposed to different intervention through three nights (ear plug, eye mask) grouping of nursing activity to be delivered before the 23:00 or delay their completion until after 08:00 where possible. Orientate patients regarding time, place and date every eight hours.

Official Title
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The Effect of Applying Multidisciplinary Bundle Intervention on the Delirium Incidence in Critically Ill Patients

Conditions
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Delirium

Intervention / Treatment
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* Other: Ear plug
* Other: Eye mask
* Other: Mixed intervention (ear plug and eye mask)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years old. No hearing problems. No eye disease. 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First intervention (ear plug)<br>Other: ear plug Other Name: eastnova ear plug | Other: Ear plug<br>* The patients will receive the first intervention (ear plug) in the third night (N3) from 9 pm to 6 am.and the patient will complete the sleep questionnaire sheet and delirium scale.<br>* Other names: eastnova ear plug;|
| Other: Second intervention (eye mask)<br>Other: eye mask The patients will receive the second intervention (eye mask) in the second night (N2) from 9 pm to 6 am. Other Name: Sleeping mask | Other: Eye mask<br>* The patients will receive the second intervention (eye mask) in the second night (N2) from 9 pm to 6 am.and the patient will complete the sleep questionnaire sheet and delirium scale<br>* Other names: Sleeping mask;|
| Other: Ear plug and eye mask<br>The patients will receive the mixed intervention (eye mask) and (ear plug ) in the first night (N1) from 9 pm to 6 am. | Other: Mixed intervention (ear plug and eye mask)<br>* The patients will receive the intervention (eye mask and ear plug) in the first night (N1) from 9 pm to 6 am.and the patient will complete the sleep questionnaire sheet and delirium scale<br>* Other names: ear plug and eye mask;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease delirium incidence | the patients will exposed to multi-component bundle | 8 month |