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IRCT20220404054409N1 IRCT 2022-04-17 Kashan University of Medical Sciences Evaluation of the effectiveness of a smartphone-based educational program on the clinical outcomes of children with severe burns and their caregivers Evaluation of the effectiveness of a smartphone-based educational program on the clinical outcomes of children with severe burns and their caregivers 2022-05-05 anticipated 90 Complete https://irct.ir/trial/62739 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Permuted Block Randomization will be used. First, all blocks of size 4 consisted of two codes A and two codes B, are prepared (6 blocks). Then, using a table of random numbers, random blocks are selected by replacement. These blocks form a sequence of 90 codes A and B, each of which is randomly assigned to one of the control or intervention groups, Blinding description: An interventional study is performed with caregivers and analyst blindness to evaluate the impact of the application on the clinical outcomes of children with severe burns and their caregivers. Caregivers are blinded in such a way that an application is installed on the phones of both intervention and control patients. But the program that is installed for caregivers in the control group only contains online questionnaires that patients must complete and submit at specified intervals. Online questionnaires include some questionnaires used to measure the target variables and include VAS and GAD questionnaires that were answered self-reportedly by caregivers in both groups and as posted online. Also, the VSS questionnaire will also be completed to assess the patient's scar status by the treating physician during the patient examination. But the program installed on the phones of caregivers in the intervention group has all the capabilities of intervention. But caregivers do not know the nature of the program installed on the phones of the opposite group. Numerical codes are also used for the analyst and intervention groups, and the letters A and B will be used for the control and intervention groups when we want to send information for analysis. N/A Burn. Intervention 1: Control group: The control group includes patients who receive their usual treatment. Intervention 2: Intervention group: Group receiving educational smartphone-based application. The intervention includes an application containing instructional text, audio, and video files. Also, reminder programs for medications and visits are set up for caregivers. Yes - There is a plan to make this available What will be shared: Participants' data file, statistical analysis and codes used in the analysis will be available in SPSS file format. Clinical study and protocol will be published by open paper. When: 6 months after study publication To whom: Final results and protocol for all people and data file and statistical file on scientific centers request Conditions: Only scientific centers can send a request for access to data for academic analysis Where to obtain: Kashan University of Medical Sciences, Paramedical School, Department of Health Information Management and Technology, Parissa Bagheri How to obtain: Request must be sent to school by post or sent to follow email: Bagheri-p@nums.ac.ir Comments:
public Dr. Fatemeh Rangraz Jedi
ًQotb-e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715973449 +98 31 5554 0021 frangrazjeddi@yahoo.com Kashan University of Medical Sciences scientific Dr. Mohammad Reza Mobayen
Namjoo street
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Caregivers of children with burns who have an Android-based smartphone and at least a basic education. TBSA >20% No mental illness or mental retardation Start of intervention from the time of discharge to 2 months after discharge. 1 day 18 years Both Children with diabetes, anemia, vascular disorders, hypotension, heart failure, various types of immunodeficiency, and malignancy. Caregivers of children who do not have the knowledge to use a smartphone properly. T20 Burn and corrosion of head, face, and neck Other Behavior Control group: The control group includes patients who receive their usual treatment. Intervention group: Group receiving educational smartphone-based application. The intervention includes an application containing instructional text, audio, and video files. Also, reminder programs for medications and visits are set up for caregivers. Scar recovery rate. Timepoint: First (discharge time), 7, 14, 21, 28, 35, 42, 49, and 56 days after discharge. Method of measurement: Vancouver Scar Scale (VSS), Visual Analogue Scale (VAS) for pain and itch. Child caregivers' anxiety. Timepoint: First (discharge time), 7, 14, 21, 28, 35, 42, 49, and 56 days after discharge. Method of measurement: Generalized anxiety disorder questionnaire (GAD). Kashan University of Medical Sciences Approved 2021-06-26 Research Ethics Committees of Kashan University of Medical Sciences Qotb-e Ravandi Blvd Kashan Isfehan Iran (Islamic Republic of)