Determining the effect of liaison nurse on family anxiety of the discharged patients from the intensive care unit
Design
Randomized clinical trail with control and test groups,32 Participants in each group, Random assignment to two groups
Settings and conduct
Patients are randomly divided into intervention and control groups. Before the intervention, the hospital's anxiety questionnaire is completed by self-reporting for the main caregiver at home. In the intervention group one day prior to the transfer of the patient to the home, a trained nurse will be introduced as the patient nurse and the family, and follow the patient for two weeks after transplanting the patient through the telephone. At the end of the second week, the anxiety questionnaire is completed again. The results are then analyzed. This study is carried out at Shahid Mohammadi Hospital in Bandar Abbas
Participants/Inclusion and exclusion criteria
The criteria for entering a patient to study:
Age older than 18 years; first admission to the ICU; at least 72 hours admitted to the ICU; history of physical illness and mental illness known prior to admission to the ICU; clearance from the intensive care unit to the general public or home
The patient's family entry criteria for study:
Family member of patient, aged over 18; ability to speak and read Persian language
Patient exit criteria from the study:
Patients transmitted unexpectedly between 8 pm and 8 am ICU to department
Exit criteria of the patient's family from the study:
Responsibility for other patient care
Intervention groups
In the intervention group, in addition to the timing training, a nurse trained as a nurse will follow the patient for two weeks and lead the caregiver in the field of nursing care.
In the control group, the patient is discharged with training that is given to the main caretaker at the time of discharge.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039317N1
Registration date:2018-07-09, 1397/04/18
Registration timing:retrospective
Last update:2018-07-09, 1397/04/18
Update count:0
Registration date
2018-07-09, 1397/04/18
Registrant information
Name
Zahra sadat keshmiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 7719
Email address
zahrakeshmiri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the role of liaison nurse on family patient's anxiety discharged from intensive care unit.
Public title
The effect of the role of liaison nurse on family patient's anxiety discharged from intensive care unit.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age is over 18
The first admission is at ICU
At least 72 hours have been admitted to the ICU
There is no history of physical illness and psychiatric illness known prior to admission to the ICU
Discharge from intensive care for public or home
A member of the family of a patient (wife, child,father,mother, sister, or brother)
Ability to speak and read Persian
Exclusion criteria:
Transferred patients between 8 pm to 8 am ICU to department
Responsibility for other patient care
Patients are transferred unexpectedly from the ICU to the department
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed simply; randomization unit was individual;the random allocation software was used.
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 in Shahid Sadoughi University of Medical Sciences Yazd
Street address
Bahonar Square., Central Building of Yazd University of Medical Sciences
City
yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
IR.SSU.REC.1396.92
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and one week and two weeks after the discharge
Method of measurement
Anxiety and depression scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group one day prior to the transfer of the patient to the home, a nurse trained as a nurse will be referred to the patient and family and will follow the phone for two weeks after transplanting the patient through the telephone.
Category
Other
2
Description
Control group: Lack of nurse interface and routine
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi hospital in Bandar Abbas
Full name of responsible person
Zahra sadat Keshmiri
Street address
Shahid mohammadi hospital., Boundary St
City
Bandar Abbas
Province
Hormozgan
Postal code
7914813937
Phone
+98 76 3334 7001
Email
zahra64nurse@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masuood Mirzaee
Street address
Deputy for research., Central Building of Shahid Sadoughi University of Medical Sciences., Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1755
Email
mmirzaei@ssu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Yazd University of Medical Sciences
Full name of responsible person
khadijeh Nasiriani
Position
Nursing PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery., Buali St., Safaieh
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
nasiriani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery., Buali street., Safaieh
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
nasiriani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
zahra sadaat keshmiri
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Forough Alley 5.,Qods Quarter
City
bandar abbas
Province
Hormozgan
Postal code
7914813931
Phone
+98 936 363 9872
Email
zahrakeshmiri@ssu.ac.ir
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Potential data is sharable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academic centers
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
Zahra Keshmiri;zahra64nurse@gmail.com
What processes are involved for a request to access data/document
Data is sent through an official request and by email