This study is a randomized controlled clinical trial. The intervention will be self-care education (activity and exercise, activity of daily life, care of burned and healed locations of the body, diet, and medications) with CD that will be conducted before patients discharged. Its effect on quality of life will be measured after 3 and 6 months with standardized questionnaire for assessing burn specific health scale-brief. Sample size will be 110 burned patients and participants will be allocated in two groups randomly. Patients in control group will receive routine care. Inclusion criteria are included: patients with 10-45% burn percentage and 1, 2, and 3 burn degree. An exclusion criterion is deterioration of patients’ condition. Before patients discharge, an education session with showing content of CD in a lab top and answer/question method for 30 minutes will be done by a co-researcher in a suitable place.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112920145N1
Registration date:2015-08-24, 1394/06/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-24, 1394/06/02
Registrant information
Name
Fatima Mohaddes Ardebili
Name of organization / entity
Iran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
mohaddes.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-06-20, 1394/03/30
Expected recruitment end date
2015-12-20, 1394/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-care education with multimedia method on quality of life in burned patients
Public title
Self-care education with multimedia method on quality of life in burned patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Age 18 to 65 Years; 10 to 45% burns; Degree burns 1, 2 and 3;
Exclusion criteria are: Death; Worsening condition.
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:
110
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Siences
Street address
Iran University of Medical Sciences, between the Highway Martyr Chamran and Martyr Sheikh Fazlullah Nuri, Martyr Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
Approval date
2014-12-09, 1393/09/18
Ethics committee reference number
93-02-28-24922-106366
Health conditions studied
1
Description of health condition studied
Burn patients, Quality of life
ICD-10 code
T29
ICD-10 code description
Burns and corrosions of multiple body regions
Primary outcomes
1
Description
Quality of life
Timepoint
pre-intervention and 3 and 6 monthes after intervention
Method of measurement
Burn Specific Health Scale – Brief
Secondary outcomes
empty
Intervention groups
1
Description
Before patients discharge, an education session with showing content of CD in a lab top and answer/question method for 30 minutes will be done by a co-researcher in a suitable place. The content of education is about self-care for burned patients.
Category
Other
2
Description
In the control group this educational process will not be performed and they will receive routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahary Hospital
Full name of responsible person
Fatima Mohaddes Ardebili
Street address
Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Syed Ali Javad Mousavi
Street address
Iran University of Medical Sciences, between the Highway Martyr Chamran and Martyr Sheikh Fazlullah Nuri, Martyr Hemmat Highway, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatima Mohaddes Ardebili
Position
Master of Science
Other areas of specialty/work
Street address
Vali Asr Avenue ,Yasami St., School of Nursing and Midwifery
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
s_mohaddes2005@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatima Mohaddes Ardebili
Position
Master of Science
Other areas of specialty/work
Street address
Vali Asr Avenue, Yasami St., School of Nursing and Midwifery
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2818
Fax
Email
s_mohaddes2005@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatima mohaddes Ardebili
Position
Master of science
Other areas of specialty/work
Street address
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
mohaddes.f@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)