The present random clinical trial pursues the goal to outline the effect of family attending Burn ICU inpatients on family anxiety in Sari based Zaare Hospital.The inclusion criteria: all attendants are over 18 yrs؛ conscious;
The exclusion criteria: addiction؛ the patient and the attendant having a record of severe mental disorder, mentally and cognitively impaired; respiratory distress, intubation, wound infection, transfer, regulations, not observing the infection control precautions. Sample: 60 patients will be randomly allocated in to intervention and control groups (each with 30 subjects). Then the training will be presented by the researcher on how to handle patient's open wound, standard infection control precautions, especially for hand washing, and participating in nutrition as the primary care. In the intervention group, the family attends the inpatient for 5 consecutive 1-h session days and before wound dressing from the 4th to the 8 hospitalization day. In the control group, the ward routine is followed (no family attendance).The patient's attendants' anxiety in the two groups will be measured via Spielberg anxiety inventory (the 3rd and 8th hospitalization day).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605017494N18
Registration date:2016-09-08, 1395/06/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-08, 1395/06/18
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2016-03-05, 1394/12/15
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Family Attending Burn ICU Inpatient Influencing Family Anxiety.
Public title
Family Attending Burn ICU Inpatient Influencing Family Anxiety.
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria: all attendants are over 18 yrs؛ conscious;
The exclusion criteria: addiction؛ the patient and the attendant having a record of severe mental disorder ; mentally and cognitively impaired ; respiratory distress; intubation؛ wound infection؛ transfer؛ regulations؛ not observing the infection control precautions.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Mazandaran University of Medical Science
Street address
Sart of valiye asr highway, Imam Square, Sari, Mazandaran
City
Sari
Postal code
4736131167
Approval date
2016-02-23, 1394/12/04
Ethics committee reference number
IR.MAZUMS.REC.95.S 103
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F90-F98
ICD-10 code description
Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
Primary outcomes
1
Description
Anxiety
Timepoint
At the 3th and 8th day of admission
Method of measurement
Spielberger anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
The one-hour-presence of the patient's desired attendant at bedside for five consecutive days before dressing by observing train cases from 4th to 8th hospitalization day
Category
Other
2
Description
Routine control group (without patient's family) to be treated.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Hospital
Full name of responsible person
Masoomeh Koohi
Street address
Zare Hospital,sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr.Ahmadali Enayati
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Masoomeh Koohi
Position
MSC in Critical Care Nursing
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, , Sari
City
Sari
Postal code
48197-53171
Phone
+98 11 3336 7342
Fax
Email
m.koohi61@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masoumeh Bagheri Nesami
Position
PHD in nursing/ faculty member
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Sari, Mazandaran
City
Sari
Postal code
48197-53171
Phone
+98 11 3336 7342
Fax
Email
anna30432003@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)