Patient Compliance, Inhalation Spacers
Conditions
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.
Interventions
OTHERAnimated Cartoon
An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.
OTHERBlack screen
A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.
Sponsors
Hôpital Necker-Enfants Malades
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 47 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| Hetero-evaluation of the cooperation of the child by the parent | At the end of the three weeks (day 21) |
Countries
France
Outcome results
None listed