Determining the effect of nursing care on the prevention of complications of sensory stimulation in patients admitted to ICU.
Design
Randomized clinical trial will be performed on 88 patients admitted to the ICU.
Settings and conduct
This study will be preformed in Besat hospital intensive care unit. Patients and researchers will not be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients admitted to the intensive care unit; Patients aged 20-70 years
Exclusion criteria: Patient death; Change in the treat process or transfer to another medical center
Intervention groups
The intervention will take place for 7 nights and from the second night of admission. In the intervention group for patients, the blindfold and earplugs are used from 10 am to 6 am at the same time and there will be no intervention in the control group and only routine care will be provided. For 7 days, daily, using the RASS scale of restlessness and using the CAM-ICU scale, the incidence of delirium by the researcher will be measured in the morning shift in both groups.
Main outcome variables
Delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N9
Registration date:2018-02-12, 1396/11/23
Registration timing:registered_while_recruiting
Last update:2018-02-12, 1396/11/23
Update count:0
Registration date
2018-02-12, 1396/11/23
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
2017-12-31, 1396/10/10
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nursing care on prevention of sensory overload stimulation in patients admitted to the intensive care unit
Public title
Effect of nursing care on prevention of sensory overload
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients admitted in intensive care unit
aged 20 to 70 years
dont have RASS score between -4 and -5
Exclusion criteria:
death
change in treatment process or transport to another ward
Age
From 20 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly, 88 patients are selected. Then, using random blocks, 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 Hamedan University of Medical Sciences
Street address
Shahid Fahmida St., Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.UMSHA.REC.1396.621
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 7 days after intervention
Method of measurement
Questionnaire and checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention will take place for 7 nights and from the second night of admission. In the intervention group, the blindfold and earplugl are used for patients from 10am to 6am at the same time.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Gholam hosein falahinia
Street address
Shahid Fahmida St., Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
falahinia@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 Fahmida St., Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 1646
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of Research and Technology of 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
Gholam hosein falahinia
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmida St., Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
falahinia@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Gholam hosein falahinia
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmida St., Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
falahinia@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi molavi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmida St., Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@umsha.ac.ir
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available