Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Animated Cartoons for Improving Cooperation During the Delivery of Inhaled Treatments to Young Children With Asthma

Conditions
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Patient Compliance, Inhalation Spacers

Intervention / Treatment
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* Other: Animated Cartoon
* Other: Black screen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 47 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group animated cartoon-black screen (AB)<br>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. | Other: Animated Cartoon<br>* An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.<br>Other: Black screen<br>* A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.<br>|
| Other: Group black screen - animated cartoon (BA)<br>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. | Other: Animated Cartoon<br>* An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.<br>Other: Black screen<br>* A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of time during which the child is non-cooperative | 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 | At the end of the three weeks (day 21) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of time during which the child is crying | Length of time during which the child is crying divided by the total length of time needed for the delivery of the inhaled treatment | At the end of the three weeks (day 21) | 
| Fraction of time during which the child is moving outside the mask | 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 | At the end of the three weeks (day 21) |