The effect of self-care educational software on the quality of life of the patients with hand burns
Design
A randomized controlled trial with control group, parallel, without blinding, using random sequences generated by SPSS software.
Settings and conduct
This study will be conducted in the burn unit of Imam Reza Hospital in Mashhad. Patients in the intervention group will use self-care software for two and half months. In the routine training group, they will be trained by nursing personnel. The questionnaire (BSHS-B) will be completed in both groups.
Participants/Inclusion and exclusion criteria
Inclusion: patients 18-65 years old with deep second or third degree burn in hands, total burn percent less than 25%, lack of deformity and motor disorders of the hands and fingers, having cell phone with internet connection.
Exclusion: Having auditory or visual problems, history of diabetes mellitus, skin allergy, MS disease, malignancy, deformity and motor disorders in the hands and fingers, mental disorders, psychoactive drugs consumption since 6 months ago and positive history of drug abuse.
Intervention groups
Patients in the intervention group will use self-care educational software for two and half months (15 days during hospitalization and 2 months after discharge). Patients of control group will receive routine training program by nursing personnel.
Main outcome variables
Quality of life of burn patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181020041386N1
Registration date:2018-11-24, 1397/09/03
Registration timing:registered_while_recruiting
Last update:2018-11-24, 1397/09/03
Update count:0
Registration date
2018-11-24, 1397/09/03
Registrant information
Name
nayereh kargar kakhki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3217 8589
Email address
kargarn951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care educational software on the quality of life of the patients with hand burns
Public title
The effect of self-care educational software on the quality of life of the patients with hand burns
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be alert
Patients with hand burns (deep second degree or third degree)
Having access to mobile phones (with Android OS)
Having the ability to use cell phone and its Apps.
Having internet access.
Signing the consent form to participate in the study
Age between 18 to 65 years
Total burn percentage is less than 25%
Patients with a thermal burn
Patients reside in Mashhad
Exclusion criteria:
Having auditory (deaf, despite the use of auxiliary equipment) and visual problem (inability to read a newspaper at a distance of 30 centimeters with glasses).
History of diabetes mellitus , skin allergy, MS disease, malignancy, deformity and motor disorders in the hands and fingers.
History of mental disorders, psychoactive drugs consumption since 6 months ago and positive history of drug abuse.
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:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment using random sequence generated by SPSS software is implemented to select patients for intervention and control group.
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 Mashhad University of Medical Sciences
Street address
Daneshgah street, Ghoreyshi building.
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-09-18, 1397/06/27
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.048
Health conditions studied
1
Description of health condition studied
Hand burns
ICD-10 code
T20-T25
ICD-10 code description
Burns and corrosions of external body surface, specified by site
Primary outcomes
1
Description
The quality of life of burn patients
Timepoint
Evaluation of the quality of life of burn patients before, 1 month and two and half months after intervention.
Method of measurement
Burn Specific Health Scale-Brief (BSHS-B) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The self-care educational software will be installed and run after introduction process in the acute phase of burn. Contents of this software will be based of the most updated educational guidelines and a team collaboration of clinicians, surgeons and physiotherapists. After discharge, the software can be used with the healthy hand or healthy fingers of patient or patient's family. The use of the software will continue for two months after the discharge. To ensure the correct running of the software, Event Log and making phone calls will be used.
Category
Rehabilitation
2
Description
Control group: Patients of the control group will receive routine patient education about burn care of hands from nursing personnel.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for burns of Imam Reza Hospital
Full name of responsible person
Ali Ahmadabadi
Street address
Imam Reza Hospital Square, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
Daneshgah Street, Mashhad University of Medical Sciences, Deputy of Research
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
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 Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery. Ebn-e-sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery. Ebn-e-sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nayereh Kargar kakhki
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery. Ebn-e-sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3217 8589
Fax
Email
kargarn951@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD