Determining the effect of nursing care on delirium prevention in patients admitted to intensive care units
Design
This study is a randomized controlled clinical trial that will be done on 60 patients.
Settings and conduct
The aim of this study is to evaluate the effect of nursing care on Delirium prevention in patients admitted to the intensive care unit of Shahid Beheshti Hospital in Hamadan. In the intervention group, educational interventions for the prevention of delirium will be lectures and booklets for nurses. Also, the posters for training on prevention of delirium and its evaluation in the department will be installed. There is no action in the control group, and ICU's usual care will be taken in the past.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, GCS score higher than 12
Exclusion criteria: Having drug addiction, Having chronic underlying disease
Intervention groups
In the intervention group, educational interventions for the prevention of delirium will be delivered as lectures and booklets for nurses. Also, the posters for training on prevention of delirium and its evaluation in the unit will be installed. There is no action in the control group, and ICU's usual care will be taken in the past.
Main outcome variables
Delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N11
Registration date:2018-04-13, 1397/01/24
Registration timing:registered_while_recruiting
Last update:2018-04-13, 1397/01/24
Update count:0
Registration date
2018-04-13, 1397/01/24
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of nursing interventions on prevention of delirium in patients admittd to intensive care unit
Public title
effects of nursing interventions on prevention of delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Satisfaction to participate in the study
GCS score higher than 12
Exclusion criteria:
Having Drug Addiction
Having chronic underlying disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly, 60 patients are selected. Then, using simple randomization method , they will be divided equally in to two groups of intervention and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Approval date
2017-11-28, 1396/09/07
Ethics committee reference number
IR.UMSHA.REC.1396.587
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Delirium
Timepoint
Before and after intervention
Method of measurement
CAM-ICU Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, nursing care for the prevention of delirium, which consists of three components, professional, environmental and related to the patient, will be carried out. The components of the professional component include training the personnel in relation to the definition and causes of the delirium ICU, the method of examining and diagnosis of delirium, and how to deal with a patient with delirium and ways to prevent delirium in ICU patients, first training in a two-hour session The lectures are provided for nurses and then the materials are provided in the form of a booklet. Also, the poster for the training of Delirium Prevention and Delirium Step-by-Step Assessment and Detection will be also provided. In the area of environmental interventions, such as setting the clock and the patient's view of the calendar, encouraging the patient to increase mobility, listening to radio and music, using proper day and night lighting, putting glasses and hearing aids at the patient's disposal, and Encouraging staff to engage more with the patient to inform the patient about time, place and recent events.
Category
Prevention
2
Description
Control group: In the control group, ICU routine care will be taken.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti
Full name of responsible person
Reza Borzou
Street address
Beheshti St, Beheshti hospital, Hamadan
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
borzou@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., University of Medical Sciences, Hamadan
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 1646
Email
Borzou@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sepideh Radfar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sepidradfar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sepideh Radfar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
sepidradfar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available