Clinical trial NCT05904197: Effectiveness of Educational Gamified Cards About Nephrotic Syndrome
Official title: Effectiveness of Educational Innovative Gamified Cards About Nephrotic Syndrome for School Age Children on Their Outcomes and Caregivers' Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrotic Syndrome
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A quasi-experimental (one-group pretest-posttest)
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effectiveness of educational innovative gamified cards about nephrotic syndrome for school age children on their outcomes and caregivers' practices

Detailed description: Nephrotic Syndrome (NS) is the most common glomerular disorder in children, globally. Eighty percent of NS cases occur in preschool-aged children (less than 6 years of age). The ratio between boys and girls is approximately 2 to 1. It requires long-term treatment and can be recurrent. Steroid responsiveness is one of the critical determinants of the disease course. It has been reported to be 5% for steroid-sensitive NS and 40%-50% for steroid-resistant NS. Although up to approximately 85% of pediatric NS, patients are reportedly sensitive to steroids, most cases relapse, with around half having frequent relapses or becoming steroid-dependent. NS not only compromises the physical health of patients but also affects their psychological health, daily functioning, general well-being, and social functioning. Children with NS are not happy and not satisfied with their lives when compared with their healthy peers. Furthermore, corticosteroid (CS) therapy can cause behavioral abnormalities in children with NS. There was a strong positive correlation between using CS therapy for a long period and the development of psychiatric disorders such as aggression, anxiety, and depression.

Children with NS have unique nutrition support needs. Children should follow a healthy, age-appropriate diet to meet energy requirements and the daily recommended intake of protein. It is recommended to continue to limit sodium, saturated, and trans-saturated fat; as these have been linked to inflammation. Standardized diet recommendations are needed for the regulation of daily energy, sodium, calcium, and vitamin D intakes. Also, the management of the associated conditions and side effects of corticosteroid treatment should be considered. Studies on self-care in childhood NS are very few especially in developing countries (Eid et al, 2020; Rousselet al., 2019). Child education and self-care empowerment are key, which involve both the ability to care for oneself and the activities necessary to achieve, maintain, or promote one's optimal health. Through self-care, various outcomes may be achieved; for example, improved symptom control, coping with the illness, and quality of life (QoL).

In recent years, there has been a lot of attention given to the trend of including game elements in non-gaming facilities. The usage of gamification in education is a massive benefit for motivation, user interaction, and social effects. Gamification is recognized and implemented in diverse areas such as marketing, politics, industry, information technology, fitness exercise, and health . Health researchers and providers have started using gamification apps to deliver medical education online and through mobile apps. Many studies defined the technical term "gamification", it is a mechanism by which game design components are implemented in non-game environments. There are different studies on educational programs that prove the effectiveness of using technologies and gamification with children to promote healthy habits in the short term. Using game-based education, children experience opportunities to solve problems through analytical thinking and improve specific skills through training and adequate feedback. Engagement is also essential for programs designed to promote healthy behaviors.

The nursing role of a child with NS includes relief from edema, enhanced nutritional status, conservation energy, supplying sufficient information about the disease, considering the importance of compliance with the medication and nutritional therapy, and prevention of infection as well as relapse. The nursing Insufficient knowledge, poor compliance to medications, and health-related advice have diverse effects on children with NS including frequent relapse, drug toxicity, higher rates of complications, increased healthcare cost of NS, and high morbidity and mortality rates. In this study, we use empowering school-age children's and their caregivers' education through gamification to support children's self-care.

Eligibility criteria: Inclusion Criteria:

* Children with confirmed diagnosis of NS.
* School age child aged between 7 to 12 years old of both gender

Exclusion Criteria:

* Children with associated congenital anomalies.
* Children with mental retardation.

Primary outcomes:
measure: Children's knowledge related to nephrotic syndrome interview questionnaire sheet pre/posttest/ follow-up
timeFrame: through study completion, an average of 6 months.
measure: Children's self-reported health-related practices interview questionnaire sheet pre/posttest/ follow-up
timeFrame: through study completion, an average of 6 months.
measure: Caregivers' knowledge related to nephrotic syndrome interview questionnaire sheet pre/posttest/ follow-up
timeFrame: through study completion, an average of 6 months.
measure: Caregivers' self-reported health-related practices interview questionnaire sheet pre/posttest/ follow-up
timeFrame: through study completion, an average of 6 months.
measure: The Pediatric Symptom Checklist-17 (Psc-17) pre / follow up
timeFrame: through study completion, an average of 6 months.
measure: Adherence to Refills and Medications Scale (ARMS) pre / follow up
timeFrame: through study completion, an average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Nursing, Mansoura University, Egypt Republik
Study officials:
affiliation: Faculty of Nursing, Mansoura University, Egypt Republik
name: Fawzia Abusaad, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhimin L. Self-care in Chinese school-age children with nephrotic syndrome. MCN Am J Matern Child Nurs. 2003 Mar-Apr;28(2):81-5. doi: 10.1097/00005721-200303000-00008.
citation: Krishnamurthy K, Selvaraj N, Gupta P, Cyriac B, Dhurairaj P, Abdullah A, Krishnapillai A, Lugova H, Haque M, Xie S, Ang ET. Benefits of gamification in medical education. Clin Anat. 2022 Sep;35(6):795-807. doi: 10.1002/ca.23916. Epub 2022 Jun 8.