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

December 20, 2015 updated by: Ghada Shalaby, Assiut University
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assuit, Egypt, 088
        • Assuit University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Head injury.
  • Psychiatric disease.
  • Shocked patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • eastnova ear plug
Other: 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 Names:
  • Sleeping mask
Other: 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 Names:
  • ear plug and eye mask

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ghada Sh Khalaf, Lecturer, faculty of nursing ,Assuit university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

December 20, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 20, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ghada 021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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