Objective: Determining the effect of orem self-care program on general health in patients with burn. Main inclusion criteria: 1) having at least 10% body surface area burns 2) after discharge from the hospital to complete rehabilitation 3) no record of certified mental illness and mental retardation, and other chronic diseases. Main exclusion criteria: 1) patients deaths 2) incidence of stressful incident during the research besides the burn 3) participation in any other training or counseling program parallel to the current program. Method: Randomized clinical trial with intervention and control. groups population: Patients with burn referred to burn clinic shiraz university of medical sciences. Sample: 110 Patients (56 of Patients in intervention group and 54 Patients in control group). Intervention: self-care program were held as five 75-90 minutes training sessions based on their self care needs for experiment group and their fellows and program adherence Followed with a phone calling every 15 days and checklist to eight weeks. Study outcome: Primary outcome was general health of the Patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122612129N2
Registration date:2014-01-10, 1392/10/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-10, 1392/10/20
Registrant information
Name
Fatemeh Rahimi dolatabad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4258
Email address
rahimidf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology of Shiraz university of medical sciences
Expected recruitment start date
2012-09-25, 1391/07/04
Expected recruitment end date
2012-12-24, 1391/10/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Orem Self- Care Program on General Health in Patients with Burn
Public title
The Impact of Orem Self- Care Program on General Health in Patients with Burn
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being in the age range 18-60 years; willingness to participate in the research; Persian literacy of reading and writing; no record of certified mental illness and mental retardation, and other chronic diseases (according to doctors records); access to a telephone for follow-up training by the researcher; having at least 10% body surface area burns; after discharge from the hospital to complete rehabilitation; participate in all training sessions Exclusion criteria: patients' deaths; incidence of stressful incident during the research (besides the burn); participation in any other training or counseling program parallel to the current program.
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:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants in the study will randomly be divided into two groups of intervention and control using the table of random numbers and the questionnaires serial numbers. The study will be double blind. The patient and the clinician are unaware of the type of the treatment that has been used.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Seventh floor, Shiraz University of Medical Sciences and Health Services, Next to Red Crescent Organization, Zand blvd
City
Shiraz
Postal code
71345-1978
Approval date
2013-12-16, 1392/09/25
Ethics committee reference number
CT-92-6812
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T31
ICD-10 code description
Burns classified according to extent of body surface involved
Primary outcomes
1
Description
General Health
Timepoint
Before, one and two months after the end of study
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: self-care program was set based on the training needs of patients within 75 to 90 minutes 5 times a week in groups of 3-5 people in a group discussion, presentation slides, training manual and ... Was administered to patients and their family members with a phone call every 15 days, and the check list for eight weeks of following the plan were followed.
Category
Rehabilitation
2
Description
Control group: routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Burn Clinic of Ghotb-al-Din-e-Shirazi Hospital
Full name of responsible person
Dr. Mahdi Ayaz
Street address
Ghotb-al-Din-e-Shirazi Burn Hospital
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Seventh floor, Shiraz University of Medical Sciences and Health Services, Zand blvd
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Hashemi
Position
MS in nursing
Other areas of specialty/work
Street address
Zand street, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1646 6560
Fax
Email
Hashemif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Hashemi
Position
MS in nursing
Other areas of specialty/work
Street address
Zand street, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1646 6560
Fax
Email
Hashemif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Hashemi
Position
MS in nursing
Other areas of specialty/work
Street address
Zand street, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1646 6560
Fax
Email
Hashemif@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)