Hospitalization in intensive care unit patients not only brings anxiety for them but can be stressful for their families. These sever anxieties result in negative effects for patient's family. Since, change in patient caring role is among the effective factors in family's anxiety level this study deals with the effects of family member's participation in ICU care plan on their stress and anxiety level.
Methods: This study is a quasi-experimental study design before and after. Family members of ICU-hospitalized patient in Ayatollah Mousavi Hospital of Zanjan city and Amin hospital of Esfahan will randomly selected and divided in two groups of experimental and control to reach the relevant numbers. The family members of experimental group appeared the patients ' bedside to participate in patients' pre-health cares for two hours a day from the 3rd day to the 7th day hospitalization. Control group will treated according to ward routine. Both groups of experimental and group will filled in stress and anxiety pre-test and post-test DASS-21 questionnaires. The data will be analyzed with SPSS-16 software and t-test and paired t-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206279664N4
Registration date:2012-08-14, 1391/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-14, 1391/05/24
Registrant information
Name
Mitra Payami Bousari
Name of organization / entity
Zanjan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6962
Email address
payami@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences and health services
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of family members participation in icu patients care plan on their stress and anxiety level
Public title
Effects of family members participation in icu patients care plan on their stress and anxiety level
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1- brother/sister / parents /children or spouse
2- Having the ability of verbal communication
3- Having the ability for doing primary care
4- Anxiety trait level not more than 60
5-no past history of self or any family member’s hospitalization in ICU
6- Participants age range: 18- 65
7- Patients age range: 20-40
8- Patients without multiple traumas or severe injuries
9-participants with no any physical or mental known disease
Exclusion criteria:
1- Disregarding from continuing participating in study
2- Disturbing ward regulations by participants
3- Doesn’t follow care protocol by participants
4- If patient dies along with intervention period time
5- If patient discharge before seventh days after admission
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The family members of experimental group appeared the patients ' bedside to participate in patients' pre-health cares for two hours a day from the 3rd day to the 7th day hospitalization. Control group was treated according to ward routine. Both groups of experimental and group filled in stress and anxiety pre-test and post-test DASS-21 questionnaires.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of medical sciences and health services
Street address
Zanjan University of medical sciences and health services,Azadi Square
City
Zanjan
Postal code
4515411447
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
8912311
Health conditions studied
1
Description of health condition studied
Stress and Anxiety
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders
Primary outcomes
1
Description
Stress
Timepoint
second and seventh day after admissinon in icu
Method of measurement
stress part of DASS 21 inventory
2
Description
Anxiety
Timepoint
second and seventh day after admissinon in icu
Method of measurement
Anxiety part of DASS21 inventory
Secondary outcomes
1
Description
family satisfactin from participating in patient care
Timepoint
seventh days after admission in icu
Method of measurement
researcher made quessionare
Intervention groups
1
Description
intervention group:
The family members of experimental group appeared the patients ' bedside to participate in patients' pre-health cares for two hours a day from the 3rd day to the 7th day hospitalization.
Category
Other
2
Description
Control group will be treated according to ward routine.participants are not allowed visited patients inspite of meeting days from out doors.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mousavi hospital of Zanjan University of Medical Sciences and Amin Hospital of Esfahan
Full name of responsible person
Zahra Sadeghi
Street address
zanjan, Nursing and midwifery faculty of Zanjan University of Medical Sciences, Parvin Etesami Ave,
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research of Zanjan university of medcial sciences and health services
Full name of responsible person
Dr. Alireza Biglari
Street address
Zanjan,Zanjan University of Medical Sciences and Health Services, Research
City
Zanjan
Grant name
بودجه طرحهای تحقیقاتی - پایان نامه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research of Zanjan university of medcial sciences and health services
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
Zanjan University of Medical sciences and health services
Full name of responsible person
Zahra Sadeghi
Position
students of master of science of intensive care nursing
Other areas of specialty/work
Street address
Nursing and midwifery faculty of Zanjan University of Medical sciences and health services, Parvin Etesami Ave,
City
Zanjan
Postal code
4515786339
Phone
+98 24 1727 2514
Fax
+98 982417270305
Email
z.sadeghi.d@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan university of medical sciences and health services
Full name of responsible person
Mitra Payami Bousari
Position
Phd, assistant professor
Other areas of specialty/work
Street address
Zanjan, Nursing and Midwifery faculty of Zanjan University of Medical Sciences and Health Services, Parvin Etesami Ave.
City
Zanjan
Postal code
4515786339
Phone
+98 24 1727 2057
Fax
+98 982417270305
Email
payami@zums.ac.irmitra_payami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of medical sciences and health services
Full name of responsible person
Mitra Payami Bousari
Position
Phd, assisstant professor
Other areas of specialty/work
Street address
Zanjan, Nursing and Midwifery faculty of Zanjan University of medical sciences , Parvin Etesami Ave.,
City
Zanjan
Postal code
4515786339
Phone
+98 24 1727 2514
Fax
+98 982417270305
Email
payami@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)