This study is conducted to determine The Effectiveness of Equilibrate Of Sensory Stimuli On Delirium Reduction In Hospitalized Patient's In the Cardiac Care Unit In Sabzevar Vaseei Hospital. In this clinical trial 80 CCU admitted patients will enroll, inclusion criteria: age older than 18 years; conscious on admission; absence underlying cognitive; Sensory and Structural brain impairment's and CCU stay More than 48 hours. exclusion criteria: hearing and vision loss; history of psychoactive drug In the last six months; and CCU stay less than 48 hours. A first group studied and after completion of the sample, the next group will be studied. interventions include: Put the clock and calendar visibility and familiarity with the environment and explain alarm devices also meeting with family members twice a day and control group receive routine ward's care. During the study, mental status; Functional and physiologic evaluation will do twice a day for three days, using standardized questionnaire Neecham and Richmond(RASS) in all samples, and the incidence of delirium in suspected cases, will confirm by observation of DSM-IV-TR criteria and psychiatrist. The incidence of delirium and cognitive scores in each of the two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101424536N1
Registration date:2016-01-28, 1394/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-28, 1394/11/08
Registrant information
Name
Moslem Mansoori
Name of organization / entity
Sabzevar University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 4424 5510
Email address
mansurim92@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University Of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Equilibrate Of Sensory Stimuli On Delirium Reduction In Hospitalized Patient's In the Cardiac Care Unit In Sabzevar Vaseei Hospital
Public title
Cotrol Of Delirium In CCU
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 years, at least two days of hospitalization in CCU, patients with heart problems are at CCU, have the ability to understand and speak Farsi, patients without sensory defects
Exclusion criteria: patients with delirium or loss of consciousness, patients with cerebrovascular syndromes and cerebrovascular problems, sensory and cognitive disorders and using Psychoactive drugs in the past six months.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Sabzevar University Of Medical Sciences
Street address
University of Medical Science Sabzevar, Sabzevar, Khorasan e Razavi
City
Sabzevar
Postal code
9613873136
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.MEDSAB.REC.1394.81
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
Incidence of Delirium
Timepoint
Twice Per Day During 3 Day’s
Method of measurement
Neecham And Reechmond Scales
Secondary outcomes
1
Description
Times Of Hospitaized
Timepoint
Times Of Discharge
Method of measurement
Patient's Document
Intervention groups
1
Description
Aware of the time and place with the clock and calendar
Category
Prevention
2
Description
Making a phone call from the patient and his family
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Vaseei Hospital
Full name of responsible person
Moslem Mansoori
Street address
Sabzevar Vaseei Hospital, Bolvar e Tohidshahr, Sabzevar, Khorasan e Razavi
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University Of Medical Sciences
Full name of responsible person
Dr Alireza Moslem
Street address
University of medical science sabzevar, Sabzevar, Khorasan e Razavi
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar Vaseei Hospital
Full name of responsible person
Moslem Mansoori
Position
Nurse
Other areas of specialty/work
Street address
Sabzevar Vaseei Hospital, Bolvar e Tohidshahr, Sabzevar, Khorasan e Razavi
City
Sabzevar
Postal code
9617747431
Phone
+98 57144653864
Fax
+98 51 4465 3867
Email
mansurim92@medsab.ac.irmoslemmansoori98@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Medical Science Sabzevar
Full name of responsible person
Mohsen Kooshan
Position
MA
Other areas of specialty/work
Street address
University of medical science sabzevar, Sabzevar, Khorasan e Razavi
City
Sabzevar
Postal code
9617913114
Phone
+98 51 4444 6070
Fax
Email
mkoushan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar Vaseei Hospital
Full name of responsible person
Moslem Mansoori
Position
Nurse
Other areas of specialty/work
Street address
Sabzevar Vaseei Hospital, Bolvar e Tohidshahr, Sabzevar, Khorasan e Razavi
City
Sabzevar
Postal code
9617913114
Phone
+98 51 4444 6070
Fax
Email
mansurim92@medsab.ac.irmoslemmansoori98@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)