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

Delirium Clinical Trial

— Ghada  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02637882
• Other study ID #: Ghada 021
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: December 17, 2015
• Last updated: December 20, 2015
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age >18 years old.

• No hearing problems.

• No eye disease.

Exclusion Criteria:

• Head injury.

• Psychiatric disease.

• Shocked patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness
• Delirium

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
Egypt	Assuit university hospital	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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.

Hellström 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease delirium incidence	the patients will exposed to multi-component bundle	8 month	Yes