Protocol summary

Summary
This study is conducted to determine the effectiveness of Nursing interventions on the Incidence of delirium in hospitalized patients in the intensive cardiac care units, of Shiraz hospitals. In this clinical trial 120 CCU admitted patients will enroll, inclusion criteria: age older than 18 years; conscious on admission; absence underlying cognitive impairment; and informed consent. exclusion criteria: hearing and vision loss; alcohol and drug dependence; history of psychoactive drug; and CCU stay less than 24 hours. The samples randomly will divide into experimental and control groups. interventions include: listening to the radio, and also meeting with family members twice a day, Interventions, will continue to discharge patients for up to one week, and control group receive routine ward's care. During the study, mental status evaluation will do twice a day, using standardized questionnaire mini mental status examination (MMSE) in all samples, and the incidence of delirium in suspected cases, will confirm by observation of DSM-IV-TR criteria.Then incidence of delirium and cognitive scores in each subjects, before and after the intervention will compare with each other and with control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012073110468N1
Registration date: 2012-10-05, 1391/07/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-10-05, 1391/07/14
Registrant information
Name
Amene Rahimi Koushki
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences And Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
amenerahimi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University Of Medical Sciences And Health Services
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study The Effectiveness Of Nursing Interventions On The Incidence Of Delirium in Hospitalized Patients In The Cardiac Care Units Of Hospitals in Shiraz, 2012
Public title
Study The Effectiveness Of Nursing Interventions On The Incidence Of Delirium in Hospitalized Patients In The Cardiac Care Units Of Hospitals in Shiraz, 2012
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: fluency in persian; older than 18 years; Conscious on admission (in patients who undergo CPR during the study , behavioral observations and clinical interviews will be postponed for at least 5 hours after resuscitation, according the previous studies). Exclusion criteria: hearing and vision loss; alcohol and drug dependence; history of cognitive impairments or psychiatric disorders; history of psychoactive drugs; and CCU stay less than24 hours.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Sadoughi University Of Medical Sciences And Health Services
Street address
Central Organization Of Shahid Sadoughi University Of Medical Sciences And Health Services, Shahid Dr Bahonar square
City
Yazd
Postal code
8916978477
Approval date
2012-06-05, 1391/03/16
Ethics committee reference number
35009/1/17/p

Health conditions studied

1

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

Primary outcomes

1

Description
Delirium Incidence
Timepoint
Duringe the hospitalization untill discharge twice a day
Method of measurement
Using standardized questionnaire mini mental status examination (MMSE) and symptoms observation according to DSM-IV-TR

Secondary outcomes

empty

Intervention groups

1

Description
Meeting with family members twice a day
Category
Prevention

2

Description
Listening to the radio programs three times a day, for 30 minutes each time
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospitals in Shiraz
Full name of responsible person
Amene Rahimi
Street address
Shahid Beheshti hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council Of Shahid Sadoughi University Of Medical Sciences And Health Services
Full name of responsible person
Zohre Kalani
Street address
Shahid Sadoughi Faculty Of Nursing And Midwifery
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council Of Shahid Sadoughi University Of Medical Sciences And Health Services
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
Shahid Beheshti Hospital
Full name of responsible person
Amene Rahimi
Position
Nurse
Other areas of specialty/work
Street address
Shahid Beheshti Hospital
City
Shiraz
Postal code
Phone
+98 71122411614
Fax
Email
Rahimi.ameneh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences And Health Services
Full name of responsible person
Zohre Kalani
Position
Master Of Science In Medical Surgical Nursing
Other areas of specialty/work
Street address
Shahid Sadoughi Faculty Of Nursing And Midwifery
City
Yazd
Postal code
89168-77443
Phone
+98 35 1824 1751
Fax
+98 35 1824 9705
Email
kalani _ z @ yahoo . com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Amene Rahimi
Position
Nurse
Other areas of specialty/work
Street address
Shahid Beheshti Hospital
City
Shiraz
Postal code
Phone
+98 71122411614
Fax
Email
Rahimi.ameneh@gmail.com
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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