Determining the effects of family members presence on the incidence of delirium in patients who admitted in cardiac intensive care unit (CICU)
Design
Clinical trial with control group with parallel groups, without blindness, randomized
Settings and conduct
In this study, 100 patients with acute coronary syndrome admitted to the coronary Care Unit of Imam Hossein Hospital in Shahroud will be selected based on the criteria of the researcher and will be randomized in the intervention and control group
Participants/Inclusion and exclusion criteria
Age over 60 years, Ability to speak and understand Persian language, Not having a sedative drug for a long time, Lack of sleep disorders like sleep apnea, The availability of first-degree relatives of the patient (including the father, mother, sister, spouse and child of the patient)
Intervention groups
Intervention group: In the intervention group, the time of visiting the first-degree relatives of the patient will be increased from one hour per day to two hours per day (one hour evening and one hour in the early hours of the night). Control group: The control group will not receive intervention and will only receive routine care and care at the hospital and discharge time.
Main outcome variables
patient's delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100114003064N10
Registration date:2018-06-30, 1397/04/09
Registration timing:registered_while_recruiting
Last update:2018-06-30, 1397/04/09
Update count:0
Registration date
2018-06-30, 1397/04/09
Registrant information
Name
Hossein Bagheri
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
bagheri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
empty
Scientific title
Evaluating the effects of family members presence on the incidence of delirium in Patients who admitted in cardiac intensive care unit (CICU)
Public title
Family members presence and delirium of Patients in cardiac intensive care unit (CICU)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Ability to speak and understand Persian language
The availability of first-degree relatives of the patient (including the father, mother, sister, spouse and child of the patient)
Exclusion criteria:
Those who are health care workers
Having sleep disorders like sleep apnea
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by block of 4: A (family members’ presence) and B (control group). The allocation will be done concealment. In this way, there will be 70 envelopes, each with A and B codes. The envelopes will be numbered. Individuals will be coded according to their entry into the study, and will be allocated an envelope for each patient to the group
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 Shahroud University of Medical Sciences
Street address
Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2017-10-30, 1396/08/08
Ethics committee reference number
Ir.Shmu.rec.1396.111
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05.9
ICD-10 code description
Delirium, unspecified
Primary outcomes
1
Description
Score of delirium incidence based on Neecham and RASS score
Timepoint
Assessment of patients' delirium in the admission as well as on the second, third and fourth days of admission
Method of measurement
Neecham and RASS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the time of visiting the first-degree relatives of the patient will be increased from one hour per day to two hours per day (one hour evening and one hour in the early hours of the night).
Category
Prevention
2
Description
Control group: The control group will not receive intervention and will only receive routine care and care at the hospital and discharge time.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Hossein Bagheri
Street address
28-meter Touhidi, Imam Khomeini Street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Hassan Emamian
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Web page address
http://research.shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Ph.D in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir square
City
Shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
3617753917
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
36147753917
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
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