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

NCT ID: NCT02637882

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

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.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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First intervention (ear plug)

Other: ear plug

Other Name: eastnova ear plug

Group Type EXPERIMENTAL

Ear plug

Intervention Type OTHER

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.

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

Group Type OTHER

Eye mask

Intervention Type OTHER

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

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.

Group Type OTHER

Mixed intervention (ear plug and eye mask)

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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eastnova ear plug Sleeping mask ear plug and eye mask

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Shalaby

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ghada Sh Khalaf, Lecturer

Role: PRINCIPAL_INVESTIGATOR

faculty of nursing ,Assuit university

Locations

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Assuit university hospital

Asyut, Assuit, Egypt

Site Status

Countries

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Egypt

References

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Hellstrom A, Willman A. Promoting sleep by nursing interventions in health care settings: a systematic review. Worldviews Evid Based Nurs. 2011 Sep;8(3):128-42. doi: 10.1111/j.1741-6787.2010.00203.x. Epub 2010 Oct 12.

Reference Type BACKGROUND
PMID: 21040451 (View on PubMed)

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.

Reference Type BACKGROUND

Rivosecchi RM, Smithburger PL, Svec S, Campbell S, Kane-Gill SL. Nonpharmacological interventions to prevent delirium: an evidence-based systematic review. Crit Care Nurse. 2015 Feb;35(1):39-50; quiz 51. doi: 10.4037/ccn2015423.

Reference Type BACKGROUND
PMID: 25639576 (View on PubMed)

Other Identifiers

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Ghada 021

Identifier Type: -

Identifier Source: org_study_id