Iran Journal of Nursing

Introduction
Congenital heart disease (CHD) refers to the structural problems of a baby’s heart or major blood vessels during fetal growth and development. Over the past 20 years, significant advances in medical treatments and surgical interventions have led to a dramatic increase in the survival rate of children with CHD. However, their all problems cannot be solved by surgery and they still need care and support measures. Parents must be able to take care of the child after the child is discharged from the hospital and should have the necessary skills to manage the care. The physical and psychological burdens of caring for a child with CHD can affect all aspects of the lives of children and their parents, and result in their poor quality of life, particularly for mothers. The quality of life of parents is one of the main predictors of the short-term and long-term consequences of CHD in children, and many studies have indicated the need for investigating the effect of supportive interventions on the quality of life of parents of children with CHD. Another factor affecting the clinical outcomes of these children is parental adherence to treatment regimens. Adherence of the family, especially mothers, to care and treatment recommendations plays a very important role in the recovery of children with CHD. One of the factors affecting the lack of adherence to treatment in parents is their insufficient knowledge and skills. Therefore, interventions that increase parents’ knowledge and care skills are among the appropriate solutions to increase their adherence to treatment recommendations for their children. A suitable educational program that includes care and disease management training can improve the quality of life and self-efficacy of parents in providing care to their children. Children of parents who receive adequate training have better clinical outcomes. 
Despite the importance of parental education and its key role in the care of children with CHD, there are shortcomings in this field in Iran. In this regard, several factors can disrupt the process of parental education, leaving the parents unaware of crucial childcare information. Given the existing shortcomings, identifying an effective solution seems necessary. One of the best ways to solve this problem is the use of e-learning. The use of mobile phones and communication technologies in healthcare and public health has led to the formation of a new concept  named “mHealth”. The mHealth has the potential to enhance healthcare delivery processes and bring significant benefits to individuals. Mobile applications have many benefits, such as being user-friendly, time efficient, flexibility in content delivery, no need for physical mobility, and easy access to information, which have caused them to be effective tools for increasing knowledge and skills. Numerous studies have reported their positive effects. This clinical trial aims to design, implement, and assess an educational mobile application for the mothers of children with CHD in Iran, to improve the mothers’ quality of life and adherence to child treatment

Methods
 The study will be conducted in the surgical ward of a hospital for children in Tehran, Iran. The study population consists of the mothers of children diagnosed with CHD seeking surgical treatment at the children’s medical center. The samples will be 72 mothers who were selected by a convenience sampling method based on the inclusion criteria, and divided into two groups of intervention and control, using the block randomization method. The control group, like the intervention group, will receive standard educational interventions using pamphlets and educational sessions during hospital discharge, administered by nursing staff. The intervention group will receive education using the designed educational mobile application.
The design of the mobile application will be done based on the ADDIE (Analyze, Design, Develop, Implement, and Evaluate) model, a well-established and widely used instructional design framework. Data collection will be done by using three questionnaires. The first questionnaire will be a demographic surveying the mother’s age, education, employment status, the child’s age, gender, and the confirmed diagnosis. The second questionnaire will be the 36-Item Short Form Health Survey (SF-36) with eight domains. The third questionnaire will be Fatemi et al.’s [32] Adherence to Treatment questionnaire, with 40 items and seven subscales. The validity and reliability of this questionnaire will be evaluated in a pilot study. The data will be collected before and one month after the intervention. To avoid the transfer of the application effect to the control group, the app will be installed exclusively on the mother’s phone on the day of discharge from the surgical ward. Furthermore, parents will be requested not to share the application with the control group. The main researcher and the data analyst will be blinded to the study results. The collected data were analyzed in SPSS software, vesion 26. P<0.05 will be considered statistically significant.

Results
The results will show the efficacy of the educational mobile application in enhancing the quality of life and treatment adherence of mothers of children diagnosed with CHD.

Conclusion
The need for educational programs for the parents of children with CHD is evident. Previous studies have reported the favorable effect of educational interventions using mobile applications on various variables, including anxiety, depression, self-efficacy, care burden, and quality of life in patients and their caregivers. This is the first study design a specialized mobile application for the education of the parents of children with CHD in Iran. It will show that the mobile-based educational intervention efficacy in improving the quality of life and treatment adherence of these mothers. 

Ethical Considerations
Compliance with ethical guidelines
This study obtained its ethical approval from the Tehran University of Medical Sciences (Code: IR.TUMS.CHMC.REC.1402.085). The study objectives and methods were explained to the participants, and informed consent was obtained from them. They were assured of the confidentiality of their information and were free to leave the study at any time.

Funding
This article was extracted from a master’s thesis in pediatric nursing, approved by Tehran University of Medical Sciences. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. 

Authors' contributions
Conceptualization: Jamaloddin Begjani, Reza Negarandeh, Mohammad Mehdi Rajabi; Data analysis: Shima Haghani; Approval of final draft: All authors.

Conflict of interest
The authors declare no conflict of interest.

Acknowledgments
The authors would like to thank all the mothers participated in this study for their cooperation.


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