Evaluating the effect of familiarizing the patient and family members with the cardiac intensive care unit environment on their perception of peripheral stressors in this unit
Determining the effect of introducing the cardiac intensive care unit environment to patients and their family members on their perception of stress
Design
Generally 90 patients and 90 family members were selected.
No healthy family member is involved among the number of patients but they are accounted in the total number of sample sizes.
Therefore, 180 samples and 90 patients are correct.
Settings and conduct
In Tehran, Bank Melli Hospital, CCU Ward
Selection Type: The patients and their families are selected by non-random and available sampling. For avoiding any interference between the intervention and control groups, after 1 week of control group’s discharge, the intervention group was chosen by non-random and available sampling and intervention is done for them.
Participants/Inclusion and exclusion criteria
Patients who are hospitalized for the first time in cardiac intensive care unit, with a family member of each patient.
Intervention groups
The control group receives only routine care provided in the CCU, but intervention group receives the program of introducing the intensive care unit environment.
Main outcome variables
Stress caused by intensive care unit environment
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20180228038902N1
Registration date:2018-06-13, 1397/03/23
Registration timing:registered_while_recruiting
Last update:2018-06-13, 1397/03/23
Update count:0
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Mehrnoosh Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 4368
Email address
mehrnooshyousefi48@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-09-23, 1397/07/01
Trial completion date
empty
Scientific title
Evaluating the effect of familiarizing the patient and family members with the cardiac intensive care unit environment on their perception of peripheral stressors in this unit
Public title
The effect of the familiarizing the patient and family members with the cardiac intensive care unit environment on their perception of stress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's inclusion criteria: Complete consciousness and lack of sensory disorders; Lack of severe forms of anxiety problems; Speaking in Farsi language; No history of hospitalization in ICU; No employment in the healthcare team. Family member inclusion criteria: 18 to 65 years old; Being relative with patient; No employment in the healthcare team; no caregiver of another patient; Speaking in Farsi language; No history of hospitalization in ICU.
Exclusion criteria:
Patient exclusion criteria: Unwilling to participate in the study; Death; Discharge or transfer from cardiac intensive care unit earlier than three days; Inability to cooperate in the study due to his or her bad heath status. Family member exclusion criteria: Unwilling to participate in the study; Causing disorder in the care unit; Causing disorder in health care program.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Determining the effect of familiarizing the patient and family member with cardiac intensive care unit environment on their stress
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences - Faculty of Nursing and Midwifery
Street address
Nosrat Street , Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-07-16, 1396/04/25
Ethics committee reference number
IR.TUMS.FNM.REC1396-4525
Health conditions studied
1
Description of health condition studied
Stress caused in cardiac intensive unit environment for patient and family member
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stress perception
Timepoint
Before familiarizing program, first 24 hours of hospitalization and 72 hours after hospitalization
Method of measurement
Questionnaire score
Secondary outcomes
empty
Intervention groups
1
Description
a program to introduce the intensive cardiac unit environment to the patients and their family members by the researcher in face to face form
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac Intensive Care Unit of National Bank Hospital
Full name of responsible person
Hosean Taheri
Street address
Ferdowsi Street
City
Tehran
Province
Tehran
Postal code
1419733176
Phone
+98 21 2661 8711
Email
hossean_658@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Keshavarz Blvd- Ghods Street., Research Deputy of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733173
Phone
+98 21 6691 4368
Email
mehrnooshyousefi48@yahoo.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnoush Yousefi
Position
Master of Nursing – Intensive Care
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tohid Square - Nosrat Street
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6691 4368
Email
seylanikh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tehran University of Medical Sciences - Faculty of Nursing and Midwifery
Position
Master of Nursing – Intensive Care
Latest degree
Medical doctor
Other areas of specialty/work
Nursery
Street address
Tohid Square - Nosrat Street
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6691 4366
Email
Kh-seylani@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tehran University of Medical Sciences - Faculty of Nursing and Midwifery
Position
master Student of Intensive Nursing Care
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tohid Square - Nosrat Street
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 66914368009821
Email
Mehrnooshyousefi48@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
All information rights belong to Tehran University of Medical Sciences
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data is shared after identification of subjects' characteristics
When the data will become available and for how long
Accessible six months after the results are published
To whom data/document is available
All researchers
Under which criteria data/document could be used
Use in systematic review studies
From where data/document is obtainable
Use in systematic review studies
What processes are involved for a request to access data/document
Tehran University of Medical Sciences
Comments
Presenting the request and receiving the University approval letter