Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications
- Conditions
- Patient ComplianceInhalation Spacers
- Interventions
- Other: Animated CartoonOther: Black screen
- Registration Number
- NCT02879240
- Lead Sponsor
- Hôpital Necker-Enfants Malades
- Brief Summary
Up to 50% of infants and young children cry during the administration of their inhaled treatment for their asthma. This results in decreased lung deposition, and thus decreased effectiveness of their inhaled treatment.
The objective of this study is to evaluate whether animated cartoons can increase the cooperation of young children with asthma who are not cooperative during the delivery of their ICS therapy through a pMDI/spacer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- Dyad parent-child.
- Parent must be 18 years or older and own a smartphone which can record videos and display animated cartoons.
- Child must be 6-47 months old, and require an inhaled corticosteroid therapy, and use a pressurized metered-dose inhaler and a spacer, and have difficulties in cooperation at least half of the time on the last week.
- Children with a medical history of epilepsy, or visual or hearing impairment not corrected by an appropriate device/treatment.
- Parents not speaking French or English.
- Parents not able to run the mobile application used to record the videos of the child despite repeated explanations.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group black screen - animated cartoon (BA) Animated Cartoon In this group, children will be exposed to a black screen during the delivery of their inhaled treatment twice a day during one week, then they will be exposed to an animated cartoon in the same conditions for one other week. Group animated cartoon-black screen (AB) Animated Cartoon In this group, children will be exposed to a animated cartoon during the delivery of their inhaled treatment twice a day during one week, then they will be exposed to a black screen in the same conditions for one other week. Group animated cartoon-black screen (AB) Black screen In this group, children will be exposed to a animated cartoon during the delivery of their inhaled treatment twice a day during one week, then they will be exposed to a black screen in the same conditions for one other week. Group black screen - animated cartoon (BA) Black screen In this group, children will be exposed to a black screen during the delivery of their inhaled treatment twice a day during one week, then they will be exposed to an animated cartoon in the same conditions for one other week.
- Primary Outcome Measures
Name Time Method Fraction of time during which the child is non-cooperative At the end of the three weeks (day 21) Length of time during which the child is crying or moving outside the mask, divided by the total length of time needed for the delivery of the inhaled treatment
- Secondary Outcome Measures
Name Time Method Fraction of time during which the child is crying At the end of the three weeks (day 21) Length of time during which the child is crying divided by the total length of time needed for the delivery of the inhaled treatment
Fraction of time during which the child is moving outside the mask At the end of the three weeks (day 21) Length of time during which the child is moving outside the mask divided by the total length of time needed for the delivery of the inhaled treatment
Trial Locations
- Locations (3)
Department of pediatrics, Mignot Hospital
🇫🇷Le Chesnay, France
Department of pediatric pulmonology, Hopital Robert Debré
🇫🇷Paris, France
Department of pediatric pulmonology, Necker Hospital
🇫🇷Paris, France