The aim of this randomized controlled trial is to evaluate the effectiveness of gamified mobile health (mHealth) applications for airway clearance therapy in children and adolescents with cystic fibrosis. Primary outcomes include Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV₁), adherence to therapy, health-related quality of life (HRQoL), and satisfaction with the intervention. The intervention will consist of 20-minute sessions, performed twice daily over a 24-week period. At least a total of 36 participants aged 8 to 18 years with cystic fibrosis will be randomly assigned to three equally sized groups: the experimental group (gamified mHealth apps: Voice Volume Catcher, Scream Go Hero, and Chicken Scream), the control group (conventional airway clearance techniques: Autogenic Drainage, Active Cycle of Breathing Techniques, and Positive Expiratory Pressure therapy), and the mixed group (10 minutes of gamified mHealth apps combined with 10 minutes of conventional techniques). This study seeks to provide evidence on the feasibility and clinical benefits of integrating gamification into airway clearance therapy to improve respiratory outcomes and patient engagement in pediatric cystic fibrosis care.
Age range
8 Years – 20 Years
Sex
ALL
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Forced Vital Capacity (FVC)
Timeframe: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Forced Expiratory Volume in the first second (FEV₁)
Timeframe: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Adherence to therapy
Timeframe: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Health-related quality of life (HRQoL)
Timeframe: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Satisfaction with the intervention
Timeframe: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.