Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders

Not yet recruiting

• Conditions: Asthma in Children; Children, Only; Serious Game
• Interventions: Device: Serious Game (SG)

• Registration Number: NCT05974917
• Lead Sponsor: Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR)

Brief Summary

The main purpose of 'Serious Games' (SG) is to provide opportunities for constructive learning and training. They are well-accepted instruments in therapeutic interventions and have been found to be efficient to improve cognitive areas, social interaction and motor skill function.

The SG is expected to improve asthmatic children's behaviour by providing a positive psychosocial experience with positive effects on asthma outcomes.

Participants will be subjected to SG as part of routine medical care, and researchers will study the effect of SG.

The aim of the study is to evaluate the impact of an innovative SG on neurobehavioural patterns through a randomised controlled pilot study in adolescents with controlled asthma and on the modulation of the expression pattern of CTRA 'Conserved Transcriptional Response to Adversity'.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-06
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03
• Study Start: 2023-09-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• diagnosis of controlled asthma according to GINA recommendations (http://ginasthma.org)

Exclusion Criteria

• flare-ups requiring oral corticosteroids within the last four weeks
• use of leukotriene receptor antagonists or therapy as required in the last four weeks
• respiratory infections within the last four weeks
• immunological, metabolic, cardiac or neurological diseases
• obesity
• preterm birth
• major malformations of the respiratory system
• active smoking
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Serious Game (SG)	with 'Serious Game' to support the asthma treatment plan

Primary Outcome Measures

Name	Time	Method
Pediatric Quality of Life Inventory (PedsQL)	6 months	Questionnaires
Skills and Difficulties Questionnaire (SDQ-Ita)	6 months

Secondary Outcome Measures

Name	Time	Method
Conserved Transcriptional Response to Adversity (CTRA)	6 months