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IRCT20230816059164N1 IRCT 2023-08-21 Tehran University of Medical Sciences Design, implementation and evaluation of an educational application for home care after surgery of pediatrics with congenital heart disease Design, implementation and evaluation of an educational application for home care after surgery of pediatrics with congenital heart disease 2023-11-22 anticipated 72 Complete https://irct.ir/trial/72115 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, the block randomization method will be used to determine the control and intervention groups. For this purpose, all blocks of 4 contain two letters A and two letters B, the total number of which is 6 (including AABB, ABAB, BABA, ABBA, BBAA, ABBA). Then 18 blocks are selected using a table of random numbers. These blocks form a sequence of 72 numbers of letters A and B, where the letter A is the symbol of the control group and the letter B is the symbol of the intervention group, and they specify how the samples are placed in the groups, Blinding description: Data collection before and after the intervention will be done by two different people. The assistant researcher will specify the type of group in which the research samples are located with the letters A and B. After collecting the data, both people will send them separately to the statistical analyst. This method of collecting information makes the main researcher and the statistical analyst not aware of the group in which the research samples are located. Also, the assistant researcher will not be aware of the final result and the effectiveness of the application. In this way, the research result is blinded from the point of view of the main researcher and the statistical analyst. The assistant researcher will follow up the samples by phone. N/A Congenital heart disease. Intervention 1: Intervention group: The intervention group will receive the home care education application, which is a guide for the care of children with congenital heart diseases after surgery. The educational content of this application, which will be approved by experts, will include information about how to take medicines, high-risk symptoms, how to perform chest physiotherapy, and other essential information needed by mothers. Quality of life and adherence to treatment of mothers before and one month after the intervention will be measured and compared. ADDIE standard application development protocol will be used to design the application. Educational applications will be developed for mobile phones with the Android operating system. During the research, the samples will be monitored through telephone follow-up. Intervention 2: Control group: For the members of the control group, routine interventions including training during discharge and phone follow-up of the samples will be done and they will not receive any new intervention. Quality of life and adherence to treatment will be measured and compared before and one month after the intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mohammad Mehdi Rajabi
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Sharghi Street, Tohid Square, Tehran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4424 mmehdirajabi1379@gmail.com Tehran University of Medical Sciences scientific Mohammad Mehdi Rajabi
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Sharghi Street, Tohid Square, Tehran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4424 mmehdirajabi1379@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Mothers should have Informed consent to participate in research Mothers should be literate and have the ability to work with mobile phones Having access to a mobile phone with Android operating system The child must have a confirmed diagnosis of congenital heart disease The child should be zero to six years old Mothers should have not received post-surgery training before no limit no limit Female The child has undergone surgery before In addition to heart disease, the child has other underlying problems Q24.9 Congenital malformation of heart, unspecified Other Other Intervention group: The intervention group will receive the home care education application, which is a guide for the care of children with congenital heart diseases after surgery. The educational content of this application, which will be approved by experts, will include information about how to take medicines, high-risk symptoms, how to perform chest physiotherapy, and other essential information needed by mothers. Quality of life and adherence to treatment of mothers before and one month after the intervention will be measured and compared. ADDIE standard application development protocol will be used to design the application. Educational applications will be developed for mobile phones with the Android operating system. During the research, the samples will be monitored through telephone follow-up. Control group: For the members of the control group, routine interventions including training during discharge and phone follow-up of the samples will be done and they will not receive any new intervention. Quality of life and adherence to treatment will be measured and compared before and one month after the intervention. Quality of Life. Timepoint: Before and one month after the intervention. Method of measurement: Quality of Life Questionnaire The 36-Item Short Form Survey (SF-36). Adherence to treatment. Timepoint: Before and one month after the intervention. Method of measurement: Modanlo et al.'s adherence to treatment questionnaire. Tehran University of Medical Sciences Approved 2023-08-16 Research Ethics Committee of Children's Medical Center, Tehran University of Medical Sciences No. 62, Next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., At the end of Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)