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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | At least twelve participants will engage in airway clearance therapy using gamified mobile health (mHealth) applications. These apps are designed to promote the control of sound intensity during open-glottis expiratory maneuvers, utilizing the smartphone's integrated microphone to detect vocal output. The sound generated during breathing reflects active respiratory effort and effective glottic control, supporting secretion mobilization and enhancing airway clearance efficacy. |
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| Control Group | Active Comparator | At least twelve participants will undergo treatment with conventional airway clearance techniques. These techniques are designed to promote effective secretion mobilization and improve lung function. Participants will be guided through a series of controlled breathing exercises aimed at optimizing airflow and enhancing secretion clearance. These methods involve active participation to perform specific maneuvers that facilitate the removal of mucus from the airways, improving overall respiratory function. |
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| Mixed Intervention Group | Active Comparator | At least twelve participants will undergo a combined intervention, consisting of 10 minutes of gamified mHealth app use followed by 10 minutes of conventional airway clearance techniques, or the sequence may be reversed. This dual approach will enable participants to benefit from both interactive digital engagement and established respiratory therapies, optimizing mucus clearance and enhancing overall pulmonary function. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamified mobile health applications | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Forced Vital Capacity (FVC) | Total volume of air that can be forcibly exhaled after a full inhalation. It is a key parameter measured during spirometry testing to assess lung function. | This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks. |
| Forced Expiratory Volume in the first second (FEV₁) | The volume of air exhaled during the first second of a forced exhalation after a full inhalation. It is a key parameter measured during spirometry testing to assess airflow and diagnose respiratory conditions. | This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks. |
| Adherence to therapy | The extent to which participants follow the prescribed therapeutic regimen. Adherence will be assessed over time using the gamified mHealth app (experimental group), a stopwatch application (control group), or a combination of both (mixed intervention group), all monitored through the StayFree app. | This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks. |
| Health-related quality of life (HRQoL) | This measure will evaluate the impact of cystic fibrosis on participants' daily lives, including physical, emotional, and social well-being. The age-adapted Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be used. The CFQ-R scores range from 0 to 100, with higher scores indicating better health-related quality of life. Cut-off points may vary depending on the study's context, but scores below 50 are often interpreted as indicating significant impairment in quality of life. | This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks. |
| Satisfaction with the intervention | The outcome will be assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM), adapted for a physical therapy intervention. This tool will measure participants' contentment with the therapy and their overall treatment experience. The TSQM scores range from 0 to 100 for each domain (effectiveness, side effects, convenience, and global satisfaction), with higher scores indicating greater satisfaction. There are no universally established cut-off points, but higher scores typically reflect more positive treatment experiences. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Andaluza de Fibrosis Quística | Seville | Seville | 41013 | Spain |
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| Conventional Airway Clearance Therapy | Other |
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| Combination Treatment | Other | - Gamified mHealth Apps (10 minutes): Voice Volume Catcher Scream Go Hero Chicken Scream - Conventional Airway Clearance Techniques (10 minutes): Autogenic Drainage Active Cycle of Breathing Techniques (ACBT) Positive Expiratory Pressure (PEP) Therapy |
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| This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks. |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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