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

Primary Purpose

Delirium

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Ear plug

Eye mask

Mixed intervention (ear plug and eye mask)

About this trial

This is an interventional supportive care trial for Delirium

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Head injury.
Psychiatric disease.
Shocked patients

Sites / Locations

Assuit university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

First intervention (ear plug)

Second intervention (eye mask)

Ear plug and eye mask

Arm Description

Other: ear plug Other Name: eastnova ear plug

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

The patients will receive the mixed intervention (eye mask) and (ear plug ) in the first night (N1) from 9 pm to 6 am.

Outcomes

Primary Outcome Measures

decrease delirium incidence

the patients will exposed to multi-component bundle

Secondary Outcome Measures

Full Information

NCT ID

NCT02637882

First Posted

December 17, 2015

Last Updated

December 20, 2015

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT02637882

Brief Title

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

Acronym

Ghada

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delirium

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

First intervention (ear plug)

Arm Type

Experimental

Arm Description

Other: ear plug Other Name: eastnova ear plug

Arm Title

Second intervention (eye mask)

Arm Type

Other

Arm 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

Arm Title

Ear plug and eye mask

Arm Type

Other

Arm Description

The patients will receive the mixed intervention (eye mask) and (ear plug ) in the first night (N1) from 9 pm to 6 am.

Intervention Type

Other

Intervention Name(s)

Ear plug

Other Intervention Name(s)

eastnova ear plug

Intervention Description

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

Intervention Name(s)

Eye mask

Other Intervention Name(s)

Sleeping mask

Intervention Description

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

Intervention Name(s)

Mixed intervention (ear plug and eye mask)

Other Intervention Name(s)

ear plug and eye mask

Intervention Description

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

Primary Outcome Measure Information:

Title

decrease delirium incidence

Description

the patients will exposed to multi-component bundle

Time Frame

8 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >18 years old. No hearing problems. No eye disease. Exclusion Criteria: Head injury. Psychiatric disease. Shocked patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ghada Sh Khalaf, Lecturer

Organizational Affiliation

faculty of nursing ,Assuit university

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assuit university hospital

City

Assuit

ZIP/Postal Code

088

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

21040451

Citation

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.

Results Reference

background

Citation

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.

Results Reference

background

PubMed Identifier

25639576

Citation

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.

Results Reference

background

Learn more about this trial

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

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