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

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ClinicalTrials.gov Identifier: NCT02637882
Recruitment Status : Unknown
Verified December 2015 by Ghada Shalaby, Assiut University.
Recruitment status was:  Enrolling by invitation
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Ghada Shalaby, Assiut University

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Delirium Other: Ear plug Other: Eye mask Other: Mixed intervention (ear plug and eye mask) Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Applying Multidisciplinary Bundle Intervention on the Delirium Incidence in Critically Ill Patients
Study Start Date : December 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arms and Interventions
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Arm Intervention/treatment
Experimental: First intervention (ear plug)

Other: ear plug

Other Name: eastnova ear plug

 Other: Ear plug
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.
Other Name: eastnova ear plug
Second intervention (eye mask)

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
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
Other Name: Sleeping mask
Ear plug and eye mask
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)
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
Other Name: ear plug and eye mask


Outcome Measures
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Primary Outcome Measures :
  1. decrease delirium incidence [ Time Frame: 8 month ]
    the patients will exposed to multi-component bundle


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years old.
  • No hearing problems.
  • No eye disease.

Exclusion Criteria:

  • Head injury.
  • Psychiatric disease.
  • Shocked patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637882


Locations
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Egypt
Assuit university hospital
Assuit, Egypt, 088
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Ghada Sh Khalaf, Lecturer faculty of nursing ,Assuit university
More Information
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Publications:
Dave K, Ashia Qureshi, L.Gopichandran, Usha Kiran. Effects of Earplugs and Eye Masks on Perceived Quality of Sleep during Night among Patients in Intensive Care Units. International Journal of Science and Research (IJSR) ISSN (Online): 2319-7064 Index Copernicus Value (2013): 6.14 | Impact Factor (2013): 4.438.

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Responsible Party: Ghada Shalaby, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT02637882    
Other Study ID Numbers: Ghada 021
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the patient's assessment sheet will be used to collect the data,the researcher will interview with the patient to complete the sleeping quality sleeping questionnaire and delirium scale
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders