Determining the Effect of Multidimensional Nursing Interventions on Delirium Prevention and Duration of Patients' Residence in Cardiac Care Units
Design
Clinical trial with non-random sampling control group
Settings and conduct
In cardiac care unit of Imam Reza hospital of Omidiyeh, First control group will be selected using available sampling method up to 55 people and they will be assessed regarding delirium and then after the discharge of last one in this group, the intervention group will be selected using non-randomized available sampling method up to 55 people and the interventions will be done. The amount of delirium onset will be measured using MMSE questionnaire and duration of hospitalization will be documented using a checklist. First the patient will be assessed regarding the level of consciousness using Glasgow coma scale and if he/she obtained the score of 15 will enter the study. One of the nurses from cardiac care unit as a researcher assistant will be taught how to work with the MMSE questionnaire. Delirium will be assessed two times a day in morning and afternoon using MMSE questionnaire.
Participants/Inclusion and exclusion criteria
Age over 18 years
Complete consciousness
Having no previous mental illness
Not having previous admissions in specialty
Not having a delirium at the time of admission
Intervention groups
At first, a training package is provided in a two-hour session for Nurses of the intensive care unit by lecture method, and the contents are provided as a booklet. A poster in the form of a multichannel nursing program is implemented in the form of a protocol.
Main outcome variables
Delirium
Multidisciplinary nursing care
Duration of stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181005041234N1
Registration date:2019-02-05, 1397/11/16
Registration timing:retrospective
Last update:2019-02-05, 1397/11/16
Update count:0
Registration date
2019-02-05, 1397/11/16
Registrant information
Name
samaneh dehghany
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4224 9587
Email address
dehghani.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
2018-09-22, 1397/06/31
Actual recruitment end date
2018-12-20, 1397/09/29
Trial completion date
2018-12-20, 1397/09/29
Scientific title
The effect of multicomponent nursing interventions on prevention of delirium and duration of patient hospitalization in cardiac care unit.
Public title
Prevention of delirium in special heart care wards
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
have a full consciousness
not having a previous mental illness
Lack of prior treatment history in cardiac special care
There is no delirium in the study .
Exclusion criteria:
Move the patient to another medical ward
The deterioration of the patient
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Actual sample size reached:
110
Randomization (investigator's opinion)
Not 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
Ethics committee of Shiraz University of Medical Sciences
Street address
Golestan University of Medical Sciences Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6373174715
Approval date
2018-09-15, 1397/06/24
Ethics committee reference number
IR.AJUMS.REC.1397.393
Health conditions studied
1
Description of health condition studied
delirium
ICD-10 code
R25.9
ICD-10 code description
Unspecified abnormal involuntary movements
Primary outcomes
1
Description
delirium
Timepoint
quarter
Method of measurement
MMSE questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Multifaceted intervention to prevent delirium based on protocol
Category
Prevention
2
Description
Control group: Routine care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
The Intensive Care Unit of Imam Reza Hospital
Full name of responsible person
Marzieh Asadi Zaker
Street address
Golestan University of Medical Sciences Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6373174715
Phone
+98 71 4224 9587
Email
marziyehasadizaker@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Golestan St, Medical Sciences Blvd,Ahvaz, Khuzestan Province, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6373174715
Phone
+98 71 4224 9587
Fax
+98 61 3336 1544
Email
marziyehasadizaker@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Ahvaz University of Medical Sciences
Full name of responsible person
Marzieh Asadi Zaker
Position
Faculty of Nursing and Head of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan St, Medical Sciences Blvd,Ahvaz, Khuzestan Province, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6373174715
Phone
+98 71 4224 9587
Email
marziyehasadizaker@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzieh Asadi Zaker
Position
Head of Nursing and Midwifery Faculty of Ahvaz
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan St, Medical Sciences Blvd,Ahvaz, Khuzestan Province, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6373174715
Phone
+98 71 4224 9587
Email
marziyehasadizaker@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzieh Asadi Zaker
Position
Head of Nursing and Midwifery Faculty of Ahvaz
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan St, Medical Sciences Blvd,Ahvaz, Khuzestan Province, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6373174715
Phone
+98 71 4224 9587
Email
marziyehasadizaker@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total of the potential data is beyond the un of individuals .
When the data will become available and for how long
Starting accession period 6 months after the results are published
To whom data/document is available
The researchers will be available in academic and academic institutions .
Under which criteria data/document could be used
to use data or documents for applied research
From where data/document is obtainable
Samaneh.dehghany68@gmail.com
What processes are involved for a request to access data/document