The presence of family next to patient in the ICU can cause to reduce family’s anxiety and has positive effect on patient recovery. Therefore this study performed to survey impact of family supportive presence on family anxiety level, nurses satisfaction and patient’s recovery in intensive care units
After randomization patients (head injury -GCS 5 to 10 - age18 to 65 years -...), a family member Of each Patient( first-degree relatives - older than 18 years -...) filled the HADS. In experimental group Family member care the patient, two times a day for 6 days. After intervention, family member filled the HADS in both groups. Then compare Changes in anxiety score between two groups .Mean of patients’ APACHE II scores as recovery criteria, was compared between two groups before and after intervention. Nurses(Bachelor of Nursing - shifts in the intervening hours,…) satisfaction estimated by a questionnaire before and after intervention period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106126776N1
Registration date:2012-03-05, 1390/12/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-05, 1390/12/15
Registrant information
Name
Tooba Hoseini Azizi
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 58 3225 0358
Email address
hoseiniat881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2011-02-14, 1389/11/25
Expected recruitment end date
2011-08-14, 1390/05/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of family supportive presence on family anxiety level, nurses satisfaction and patient’s recovery in intensive care units
Public title
Impact of family supportive presence on family anxiety level, nurses satisfaction and patient’s recovery in intensive care units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria ( patient): -head injury -GCS 5 to 10 - age18 to 65 years -...
Exclusion criteria: -discharge from the ICU before sixth day -...
Inclusion criteria(family members): - first-degree relatives - older than 18 years -...
Inclusion criteria( nurses): - Bachelor of Nursing - Shifts in the intervening hours.
Exclusion criteria: -not complete questionnaire on second time - time off for more than a third of the entire course of study -...
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:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Science
Street address
Daneshgah st. Ghoreishi building
City
Mashhad
Postal code
Approval date
2011-02-14, 1389/11/25
Ethics committee reference number
89487
Health conditions studied
1
Description of health condition studied
Head injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Family anxiety
Timepoint
Before and after intervention
Method of measurement
Hospital anxiety and deppresion scale
2
Description
Patient outcome
Timepoint
Before and after intervention
Method of measurement
APACHE II
3
Description
Nurse satisfaction
Timepoint
Before and after intervention
Method of measurement
Satisfaction questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Family member was present alongside his patient after the necessary training
And care about ( introduction to the patient, informing him of the time, place and the happy memories of the past, reading the Quran and praying, tactile contact with the patient , Cleaning wet lips, nose and eyes of patients with wet gauze, applying soothing cream on the hands and feet of the patient, help staff to change position ,movement hand and foot joints of patients) was performed. Presence of family members twice a day (12 to 13 and 18 to 19) in the first six days of patient admision
Category
Treatment - Other
2
Description
Control group: Routin patient care and forbidden patient visitation
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Kamyab trauma hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Dr. Mohammad Ramezani
Street address
Daneshgah st. Ghoreishi building
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Science
Full name of responsible person
Tooba bi bi Hoseini Azizi
Position
Master student
Other areas of specialty/work
Street address
Imam khomeini st.
City
Bojnourd
Postal code
Phone
+98 58 4225 0358
Fax
Email
hoseini.tooba@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Tooba bi bi Hoseini Azizi
Position
Master student
Other areas of specialty/work
Street address
Imam khomeini st.
City
Bojnourd
Postal code
Phone
+98 58 4225 0358
Fax
Email
hoseini.tooba@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Tooba bi bi Hoseini Azizi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)