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

A

Assiut University

Status and phase

Unknown
Phase 2

Conditions

Delirium

Treatments

Other: Mixed intervention (ear plug and eye mask)
Other: Eye mask
Other: Ear plug

Study type

Interventional

Funder types

Other

Identifiers

NCT02637882
Ghada 021

Details and patient eligibility

About

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).

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Head injury.
  • Psychiatric disease.
  • Shocked patients

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

50 participants in 3 patient groups

First intervention (ear plug)
Experimental group
Description:
Other: ear plug Other Name: eastnova ear plug
Treatment:
Other: Ear plug
Second intervention (eye mask)
Other group
Description:
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
Treatment:
Other: Eye mask
Ear plug and eye mask
Other group
Description:
The patients will receive the mixed intervention (eye mask) and (ear plug ) in the first night (N1) from 9 pm to 6 am.
Treatment:
Other: Mixed intervention (ear plug and eye mask)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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