Protocol summary

Summary
Objective: Determining the effect of orem self-care program on self-efficacy and quality of life 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)confirmation of mental illness and mental retardation and other chronic diseases. Main exclusion criteria: 1)patients deaths 2)a stressful event during the study except burns 3)participate in any training or consulting other parallel to it. 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 experimental group and their fellows and program adherence Followed with a phone calling every 15 days and checklist to eight weeks. Study outcomes: Primary outcomes was self-efficacy and quality of life Patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013042112129N1
Registration date: 2013-06-03, 1392/03/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-03, 1392/03/13
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 Self-Efficacy and Quality of Life in Patients with Burn Referred to Ghotbedin shirazi Burn Clinic Shiraz-Iran , 2012
Public title
The Impact of Orem Self- Care Program on Self-Efficacy and Quality of Life in Patients with Burn
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being in the age range 18-60; Willing to engage in research; Persian literate enough to read and write; Confirmation of mental illness and mental retardation and other chronic diseases (according to doctor 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; a stressful event during the study (except burns); Participate in any training or consulting other parallel initiatives.
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Shiraz University of Medical Sciences
Street address
Seventh floor, Shiraz University of Medical Sciences and Health Services, Next to Red Crescent Organazation, Zand blvd
City
Shiraz
Postal code
1978-71345
Approval date
2012-10-07, 1391/07/16
Ethics committee reference number
CT-91-6263

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
Self-Efficacy
Timepoint
Before intervention, 1 month and 2 month after intervention
Method of measurement
Questionnaire

2

Description
Quality of Life
Timepoint
Before intervention ,1 month and 2 month after intervention
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 Ghotbedinshirazi Hospital
Full name of responsible person
Dr Mahdi Ayaz
Street address
Ghotbedin 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)
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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