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Influence of a multifactor-adjusted intervention based on NICE's guidline on prevention of delirium Patients admitted for open heart surgery

Protocol summary

Summary
This research studies the influence of a multifactor-adjusted intervention based on NICE's guideline on prevention of delirium Patients admitted for open heart surgery of Imam Khomine hospital at 2014. In this semi-experimental clinical trial, 88 recruit patients are divided in two intervention and control groups. Inclusion criteria are who has no alcohol, addiction, Dementia, psychotropic drugs. Patients are removed required emergency surgery. Intervention is overcome cognitive disorders, dehydration, constipation, and infection, pain and sleep disorders. Demographic, sleep information are completed by questioners. The incidence of delirium is recorded by CAM-ICU.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201403138286N5
Registration date: 2014-05-27, 1393/03/06
Registration timing: na

Last update:
Update count: 0
Registration date
2014-05-27, 1393/03/06
Registrant information
Name
Fatemeh Bahramnezhad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
fatemeh_bahramnezhad@yahoo.com
Recruitment status
Not enough for processing
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-07-16, 1393/04/25
Expected recruitment end date
2014-07-10, 1393/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of a multifactor-adjusted intervention based on NICE's guidline on prevention of delirium Patients admitted for open heart surgery
Public title
Multifactor-adjusted intervention based and delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; no cognitive disorders such as dementia; no loss of hearing and vision; lack of mental disorders such as psychosis and depression; no delirium during the study; no alcoholism; open heart surgery during the study; no use drug. Exclusion criteria: unwillingness to participate in the study; require emergency open heart surgery; need for reoperation.
Age
From 65 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethical Review Commiitee of Tehran University of Medical Sciences
Street address
Central Building, Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2014-05-20, 1393/02/30
Ethics committee reference number
93/د/130\406

Health conditions studied

1

Description of health condition studied
Delirium
ICD-10 code
F05.0
ICD-10 code description
Delirium, not induced by alcohol and other psychoactive substances

Primary outcomes

1

Description
Delirium
Timepoint
Every12hours
Method of measurement
CAM-ICU questioner

Secondary outcomes

1

Description
Pain
Timepoint
During painful procedure
Method of measurement
Critical care pain observation tool

2

Description
Quality of sleep
Timepoint
Daily
Method of measurement
Pittsburgh questionnaire

Intervention groups

1

Description
Intervention group: NICE guideline order (removed cognitive disorder, Dehydration, Pain, Constipation)
Category
Prevention

2

Description
Control group: Delirium of survey by CAM-ICU twice in day
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
MohammadAli cheraghi
Street address
Dr Garib St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Younesian
Street address
Central Building, Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Hazaryan
Position
Master of nursing
Other areas of specialty/work
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq.,
City
Tehran
Postal code
Phone
+98 21 2166 9271
Fax
Email
m.hazaryan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
Ph.D
Other areas of specialty/work
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq.,
City
Tehran
Postal code
Phone
+98 21 2566 3349
Fax
Email
bahramnezhad@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Hazaryan
Position
Master of Nursing
Other areas of specialty/work
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq.,
City
Tehran
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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