The Effect of Self-Efficacy Promoting Program Using Computer Game on Proteinuria in Thai Children With Nephrotic Syndrome

Not Applicable

Completed

• Conditions: Nephrotic Syndrome in Children
• Interventions: Behavioral: Standard nursing care; Behavioral: Self-efficacy promoting program using computer game

• Registration Number: NCT06524986
• Lead Sponsor: Chulalongkorn University

Brief Summary

Nephrotic syndrome is a medical condition where the kidneys release substantial amounts of protein into the urine, resulting in various issues such as tissue swelling and an increased susceptibility to infections. Emphasizing the importance of adequate nutrition and symptom monitoring is crucial in managing urine protein levels and mitigating associated complications.

The purpose of this study was to boost self-efficacy through a computer game-based program, aiding pediatric patients with Nephrotic syndrome in the adoption of healthy eating habits and efficient management of urine protein levels.

Detailed Description

This study was Quasi-experimental Research. Two group pre-test post-test with repeated measures design. Forty school-age children diagnosed with nephrotic syndrome were randomly allocated into two groups, with the participants distributed between an experimental group and a control group, each comprising 20 individuals. The experimental group underwent a program that aimed to enhance self-efficacy through computer games for a duration of 5 weeks, whereas the control group received regular nursing care. Information was gathered through personal record forms, urine protein assessments with test strips, dietary behavior surveys for school-age children with nephrotic symptoms, and self-efficacy surveys related to dietary behavior within the same group. The data underwent analysis using repeated measures analysis of variance. Statistical significance was defined as p \< .05.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-07-30
• Status Verified: 2024-07
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Confirmation of nephrotic syndrome diagnosis by a physician and continuous hospital treatment for a minimum of 3 months.
• Presence of proteinuria levels at 1+ or higher during morning awakening or a urine protein quantity exceeding 30 mg/dL within the past 6 months (verified through medical records).
• Proficient communication skills in the Thai language.
• Ownership of a telephone or device suitable for gaming and internet connectivity.
• Willingness and cooperation from both the family and the child to actively participate in the research.
• Discontinuation of steroid medication by school-age patients.

Exclusion Criteria

• involve symptoms indicative of a critical condition, such as entering a crisis or severe complications like heart failure or pleural effusion.
• school-age patients whose treatment plan has been modified by a physician, including the use of injectable medication instead of oral drugs or those receiving treatment in an inpatient setting.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard nursing care	Standard nursing care	The control group received standard nursing care, which included providing dietary recommendations for pediatric patients. The recommended daily intake consisted of 0.8 grams of protein per kilogram of the child's weight, low-sodium foods, and low-fat options. This personalized guidance was communicated through informational brochures.
Self-efficacy promoting program	Self-efficacy promoting program using computer game	The self-efficacy promotion program, inspired by Bandura's principles (1997, 2001) and employing computer games, extends across 5 weeks with 30-minute sessions conducted 10 minutes.The program involved activities such as motivation, modeling, and enactive mastery experiences. Weekly sessions covered collaborative planning, video demonstrations, interactive gaming, and follow-up calls to ensure active participation and address concerns related to physiological and affective states.

Primary Outcome Measures

Name	Time	Method
Protein levels in the urine	Change from Baseline Protein levels in the urine at 5 weeks, followed by three days of consecutive follow-up calls	Urine dipstick test assessments with COMBI-SCREEN® GP test strips

Trial Locations

Locations (1)

Faculty of Nursing, Chulalongkorn University; 🇹🇭 Pathum Wan, Bangkok, Thailand