Protocol summary

Summary
This study is a befor-after randomized clinical trial.We want to evaluate the effects of family centered care on family satisfaction in intensive care unit.The statistical research community was the relatives of hospitalised patients in neurosurgery intensive care unit and surgery intensive care unit of shahid rahnemoon hospital, yazd, iran. The sample size are 84 patients. The patient and his family member should be older than 18 years and the patient to be hospitalized at least 7 days in ICU.The exclusion criteria is a family member with diagnosed mental disease. Family satisfaction will measured in the third day of hospitalization of the patients in ICU by a questionnaire. In cotrol group will perform rutine care. researcher in intervention group will educate the ICU rules, equipments and unit patient and patient diagnose to family member. she let the family help the patient in some cases of the public health(such as shaving, hand and foot massage, mouth care, eye care and giving food). The patient family member will contacted if there is a significant change in the patient condition.The patient family member family will involved in the new decisions about the patient. Family satisfaction will measured in both groups after 4 days.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013091014613N1
Registration date: 2013-11-27, 1392/09/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-11-27, 1392/09/06
Registrant information
Name
Leili Fooladi
Name of organization / entity
Shahid Sadoghi University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 2522 3001
Email address
fooladi.leili@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahid Sadoghi University of Medical Science
Expected recruitment start date
2013-10-04, 1392/07/12
Expected recruitment end date
2014-02-01, 1392/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness Of Family Centered Care On Family Satisfaction In Intensive Care Unit
Public title
Family Centered Care
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:The patient and his family member to be older than 18 years, to be hospitalized at least 7 days in ICU, willing to participate in the study, having the power to speak and write in Farsi. Exclusion criteria: Family member not to be eligible if they have diagnosed psychoatric illness
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
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
Shahid Sadoughi University of Medical Sciences
Street address
yazd- shahid bahonar square-shahid sadoughi university of medical sciences
City
yazd
Postal code
8916978477
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
79754

Health conditions studied

1

Description of health condition studied
Injury, Neoplasm
ICD-10 code
I60, I61,
ICD-10 code description
Subarachnoid haemorrhage, Intracerebral haemorrhage, Other nontraumatic intracranial haemorrhage, Cerebral infarction, Malignant neoplasm of brain, Malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system, Intracranial i

Primary outcomes

1

Description
family satisfaction
Timepoint
third day and seventh day
Method of measurement
questionnare

Secondary outcomes

empty

Intervention groups

1

Description
In third day of hospitalization, researcher in intervention group will educate the ICU rules, equipments and unit patient and patient diagnose to family member. she let the family help the patient in some cases of the public health(such as shaving, hand and foot massage, mouth care, eye care and giving food). The patient family member will contacted if there is a significant change in the patient condition.The patient family member family will involved in the new decisions about the patient. This will countinue for 4 days.
Category
Other

2

Description
In cotrol group will perform rutine care and family member willnot assisst in patient care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
shahid rahnemoon hospital
Full name of responsible person
Fooladi Leili MS nursing student
Street address
Iran-yazd- shahid rahnemoon hospital , mehriz parastar squar fatemeh alzahra hospital
City
yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoghi University of Medical Science
Full name of responsible person
fatemeh ezzadini
Street address
yazd- shahid bahonar squar-shahid sadoughi university of medical science
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoghi University of Medical Science
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
Shahid Sadoghi University of Medical Science
Full name of responsible person
leili fooladi
Position
master of scince nursing student
Other areas of specialty/work
Street address
yazd- mehriz-hafte tir avenu- parastar squar- fatemeh alzahra hospital
City
mehriz
Postal code
Phone
+98 35 2522 3001
Fax
+98 35 2522 3005
Email
fooladi.leili@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoghi University of Medical Science
Full name of responsible person
farahnaz farnia
Position
phd of nursing
Other areas of specialty/work
Street address
yazd-safaieh-in front of infertility center
City
yazd
Postal code
89168774413
Phone
+98 35 1824 1751
Fax
Email
far.farnia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoghi University of Medical Science
Full name of responsible person
Fooladi Leili
Position
MS nursing student
Other areas of specialty/work
Street address
yazd- mehriz- fatemeh alzahra hospital
City
mehriz
Postal code
Phone
+98 35 2522 3001
Fax
Email
fooladi.leili@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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