This controlled clinical trial study will conduct to determine the effectiveness of sensory modification on delirium incidence and cognitive status in patients of open heart surgery intensive care unit at Amiralmomenin Medical and Educational Center in Kordkuy city in 2015. 120 eligible patients undergoing CABG will be selected via convenience sampling, and then patients will be allocated into two intervention and control groups by using stratified random allocation. Patients in both groups will receive routine nursing care. Furthermore, in intervention group multidimensional intervention for sensory modification will be done including the use of blindfold and earplugs from 12 at night to 6 in the next morning from two to five days after surgery. In addition, family members will visit their patient daily (from 18 to 18:30) to touch and talk them and to orient them to time, place, and person. In both groups delirium incidence will be determined using the Neacham scale and cognitive status will be assessed using the MMSE checklist. Before intervention and 4 consecutive days after intervention (from 2 to 5 days after operation) cognitive status and incidence of delirium will be assessed by trained nurses once in each shift. The data will be analyzed in SPSS-16 software using descriptive, χ2 and Kruskal–Wallis tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121517237N6
Registration date:2015-10-29, 1394/08/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-29, 1394/08/07
Registrant information
Name
Mahnaz Modanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 6900
Email address
modanloo.mahnaz@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Golestan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of sensory modification on delirium incidence and cognitive status in open heart surgery intensive care unit's patients
Public title
The effects of sensory modification on delirium incidence and cognitive status in open heart surgery intensive care unit's patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age between 18 and 65 years old
2. The lack of known visual disturbances
3. The lack of known hearing impairment
4. Absence of known psychiatric disorders
5. The lack of known motor disorders in limbs
6. Lack of delirium at baseline
7. Without preoperative cognitive impairment
Exclusion criteria:
1. Patients who will be discharged or died during the study
2. The need for CPR during study
3. Patients dissuade for continuing to work with researchers
4. The need for re-operation
Age
From 17 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization strategies: Considering age and gender, patients will be allocated into two intervention and control groups. Allocation will be achieved using stratified random allocation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Postal code
4934174515
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
ir.goums.rec.1394.86
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05.8
ICD-10 code description
Other delirium (Postoperative delirium)
Primary outcomes
1
Description
Delirium
Timepoint
Before and two days after intervention
Method of measurement
Using the NeaCham scale
Secondary outcomes
1
Description
Cognitive status
Timepoint
From two to five days after operation
Method of measurement
By using the MMSE instrument
Intervention groups
1
Description
Intervention group: In addition to routine care, multidimensional intervention for sensory modification will be done including the use of blindfold (made of black cloth), earplugs (Mark Elvex Quattro four-step model, lace) from 12 at night to 6 in the next morning from two to five days after surgery. In addition, family members will visit their patient daily (from 18 to 18:30) to touch and talk them and to orient them to time, place, and person.
Category
Prevention
2
Description
Control group: without any intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Medical & Educational Center
Full name of responsible person
Gholam Ali Riahi
Street address
Amiralmomenin Medical & Educational Center, Mirza Kochak Khan street, Kordkuy
City
Kordkuy
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Golestan University of Medical Sciences
Full name of responsible person
Masood KhoshNia
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan Gorgan
City
Gorgan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Golestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
MS Student of Critical Nursing Care
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Bulvar, Gorgan
City
Gorgan
Postal code
4917136536
Phone
+98 17 3436 8856
Fax
Email
mostafa.darzi@yahoo.com
Web page address
www.goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mahnaz Modanloo
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Bulvar, Gorgan
City
Gorgan
Postal code
4917136536
Phone
+98 17 3242 6900
Fax
+98 17 3242 5171
Email
modanloo.mahnaz@goums.ac.ir; modanloo1@yahoo.com
Web page address
http://goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
MS Student of Critical Nursing Care
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Bulvar, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3436 8856
Fax
Email
mostafa.darzi@yahoo.com
Web page address
http://goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)