This study investigates the effect of a family-centered care on the anxiety of family members in the first week of patient hospitalization in the intensive care unit. Eighty family members of the patients are selected through a consecutive sampling in the intensive care units of Sina hospital in Tehran. They are allocated in trial and control groups by stratified randomization. The participant anxiety is assessed in the second and the sixth day of patients᾿ hospitalization using Hospital Anxiety and Depression Scale. In trial group, the family members are allowed to be present at the bedside on the evening shift from the second till the sixth day. Oral information about the equipments and regulations as well as a daily information card consisting of the treatments and care activities, vital signs and patient level of consciousness are presented to the participants and their questions are answered. The control group can see the patient across the window according to the ward routine. The mean anxiety scores as well as the frequencies of high anxiety are compared in two groups in the second and the sixth day.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081823670N1
Registration date:2015-09-17, 1394/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-17, 1394/06/26
Registrant information
Name
Farzaneh Golaghaie
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3524
Email address
golaghaei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Arak University of Medical Sciences
Expected recruitment start date
2014-10-20, 1393/07/28
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of family-centered care on the anxiety of the familiy members of patients hospitalized in intensive care units
Public title
Effects of family-centered care on the anxiety of the familiy members of patients hospitalized in intensive care units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Less than 24 hours past from the patient admission ; being the first degree family member; introduced as the representative of the family on behalf of the other members; having at least fifth grade of primary education; not having health care related jobs; not having previous psychiatric disease or disorder.
Exclusion criteria: Not willing to continue participation in the study; patient transport or death before the sixth day.
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:
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
Ethics Committee of Arak University of Medical Sciences
Street address
Academic site of Payambar A᾿zam, Basij Square
City
Arak
Postal code
6941738481
Approval date
2014-10-20, 1393/07/28
Ethics committee reference number
1-169-93
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Family member anxiety
Timepoint
the second and the sixth day of patient hospitalization
Method of measurement
Hospital Anxiety and Depression Scale
Secondary outcomes
empty
Intervention groups
1
Description
In trial group, the family members are allowed to be present at the bedside on the evening shifts from the second to the sixth day. Oral information about the equipments and the regulations as well as a daily information card consisting of treatment and care activities, vital signs and the patient level of consciousness are delivered to the participants and their questions are answered.
Category
Other
2
Description
In control group, the family members can see the patient across the window according to the ward routines.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Malihe Vafaie
Street address
Sina Hospital, Hasanabad square, Imam Khomeini street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Ghazavi
Street address
Academic Site of Payambar A᾿zam, Basij Suare
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Farzaneh Golaghaie
Position
Faculty Member/ Ph.D
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery , Academic site of Payambar A᾿zam, Basij Square
City
Arak
Postal code
6941738481
Phone
+98 86 3417 3524
Fax
Email
fgolaghaie@gmail.com; golaghaei@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Farzaneh Golaghaie
Position
Faculty member/Ph.D
Other areas of specialty/work
Street address
Facuty of Nursing and Midwifery, Academic site of Payambar A᾿zam, Basij square
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
Email
fgolaghaie@gmail.com; golaghaei@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Farzaneh Golaghaie
Position
Faculty member/ Ph.D
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Academic site of Payambar A᾿zam, Basij square
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
Email
fgolaghaie@gmail.com; golaghaei@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)