Serious gaMe Come Interventi Emergenti di E-health Per i Giovani Con distuRbi neuroLogici o rEspiratori (SMILER) - Progetto@Cnr
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- Pediatric Quality of Life Inventory (PedsQL)
Study Overview
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'.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •preterm birth
- •major malformations of the respiratory system
- •active smoking
- •pregnancy
Outcomes
Primary Outcomes
Pediatric Quality of Life Inventory (PedsQL)
Time Frame: 6 months
Questionnaires
Skills and Difficulties Questionnaire (SDQ-Ita)
Time Frame: 6 months
Secondary Outcomes
- Conserved Transcriptional Response to Adversity (CTRA)(6 months)