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

NCT02637882 | Unknown Phase 2 DMC

• 1 other identifier: Ghada 021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• decrease delirium incidence

  the patients will exposed to multi-component bundle

  8 month

Study Arms (3)

First intervention (ear plug)

EXPERIMENTAL

Other: ear plug Other Name: eastnova ear plug

Other: Ear plug

Second intervention (eye mask)

OTHER

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

Ear plug and eye mask

OTHER

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)

Interventions

Ear plug 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.

Also known as: eastnova ear plug

First intervention (ear plug)

Eye mask 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

Also known as: Sleeping mask

Second intervention (eye mask)

Mixed intervention (ear plug and eye mask) 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

Also known as: ear plug and eye mask

Ear plug and eye mask

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Head injury.
• Psychiatric disease.
• Shocked patients

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university hospital

Asyut, Assuit, 088, Egypt

Location

Related Publications (3)

• 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.

  PMID: 21040451 BACKGROUND

• 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.

  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.

  PMID: 25639576 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ghada Sh Khalaf, Lecturer

  faculty of nursing ,Assuit university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 22, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 22, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)