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

Phase 2

• Conditions: Delirium
• Interventions: Other: Ear plug; Other: Mixed intervention (ear plug and eye mask); Other: Eye mask

• Registration Number: NCT02637882
• Lead Sponsor: Assiut University

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).

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 Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-20
• Last Update Submitted: 2015-12-20
• Study First Posted: 2015-12-22
• Last Update Posted: 2015-12-22
• Primary Completion: 2016-05
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Head injury.
• Psychiatric disease.
• Shocked patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First intervention (ear plug)	Ear plug	Other: ear plug Other Name: eastnova ear plug
Ear plug and eye mask	Mixed intervention (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.
Second intervention (eye mask)	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

Primary Outcome Measures

Name	Time	Method
decrease delirium incidence	8 month	the patients will exposed to multi-component bundle

Trial Locations

Locations (1)

Assuit university hospital; 🇪🇬 Assuit, Egypt