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

NCT ID: NCT06524986

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nephrotic Syndrome in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Self-efficacy promoting program

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.

Group Type EXPERIMENTAL

Self-efficacy promoting program using computer game

Intervention Type BEHAVIORAL

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. Activities include: 1) Enactive Mastery Experiences 2) Modeling 3) Verbal Persuasion 4) Physiological and Affective States Assessment

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.

Group Type EXPERIMENTAL

Standard nursing care

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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. Activities include: 1) Enactive Mastery Experiences 2) Modeling 3) Verbal Persuasion 4) Physiological and Affective States Assessment

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Suwimon Rojnawee, PhD, RN

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suwimon Rojnawee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Nursing, Chulalongkorn University

Pathum Wan, Bangkok, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

Leddy J, Green JA, Yule C, Molecavage J, Coresh J, Chang AR. Improving proteinuria screening with mailed smartphone urinalysis testing in previously unscreened patients with hypertension: a randomized controlled trial. BMC Nephrol. 2019 Apr 18;20(1):132. doi: 10.1186/s12882-019-1324-z.

Reference Type RESULT
PMID: 30999886 (View on PubMed)

Jari M, Merrikhi A, Kelishadi R, Ghaffarzadeh Z. The First Report on the Frequency of Asymptomatic Proteinuria in Iranian School-aged Children. Adv Biomed Res. 2018 Feb 21;7:35. doi: 10.4103/2277-9175.225923. eCollection 2018.

Reference Type RESULT
PMID: 29531933 (View on PubMed)

Kato-Lin YC, Kumar UB, Sri Prakash B, Prakash B, Varadan V, Agnihotri S, Subramanyam N, Krishnatray P, Padman R. Impact of Pediatric Mobile Game Play on Healthy Eating Behavior: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 18;8(11):e15717. doi: 10.2196/15717.

Reference Type RESULT
PMID: 33206054 (View on PubMed)

Mishra R, Kumari S, Pathak A, Prasad KN, Malakar J. Risk factors for relapse in pediatric nephrotic syndrome in Ranchi. J Family Med Prim Care. 2023 Feb;12(2):223-226. doi: 10.4103/jfmpc.jfmpc_983_22. Epub 2023 Feb 28.

Reference Type RESULT
PMID: 37090998 (View on PubMed)

Downie ML, Gallibois C, Parekh RS, Noone DG. Nephrotic syndrome in infants and children: pathophysiology and management. Paediatr Int Child Health. 2017 Nov;37(4):248-258. doi: 10.1080/20469047.2017.1374003. Epub 2017 Sep 15.

Reference Type RESULT
PMID: 28914167 (View on PubMed)

Esezobor C, Ademola AD, Adetunji AE, Anigilaje EA, Batte A, Jiya-Bello FN, Furia FF, Muoneke U, McCulloch M, Nourse P, Obiagwu P, Odetunde O, Okyere P, Solarin A, Tannor EK, Noone D, Gbadegesin R, Parekh RS; Human Hereditary and Health in Africa Kidney Disease Research Network. Management of idiopathic childhood nephrotic syndrome in sub-Saharan Africa: Ibadan consensus statement. Kidney Int. 2021 Jan;99(1):59-67. doi: 10.1016/j.kint.2020.07.045. Epub 2020 Aug 29. No abstract available.

Reference Type RESULT
PMID: 32866504 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0814/65

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of Child Injury Based on Data Mining
NCT04528810 NOT_YET_RECRUITING
Effectiveness of Contrast-Enhanced Ultrasound
NCT03473249 ACTIVE_NOT_RECRUITING PHASE4
CEUS for Blunt Abdominal Trauma in Children
NCT03490929 RECRUITING PHASE4