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

I

Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR)

Status

Not yet enrolling

Conditions

Serious Game
Asthma in Children
Children, Only

Treatments

Device: Serious Game (SG)

Study type

Observational

Funder types

NETWORK

Identifiers

NCT05974917
Verbale N° 01/2023

Details and patient eligibility

About

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'.

Enrollment

30 estimated patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Group 1
Description:
with 'Serious Game' to support the asthma treatment plan
Treatment:
Device: Serious Game (SG)
Group 2
Description:
without 'Serious Game' and will follow the standard treatment plan

Trial contacts and locations

0

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Central trial contact

Stefania La Grutta, MD

Data sourced from clinicaltrials.gov

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