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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group animated cartoon-black screen (AB) | Other | 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) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Animated Cartoon | Other | An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child. |
|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hetero-evaluation of the cooperation of the child by the parent | At the end of the three weeks (day 21) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Drummond, M.D. | Necker hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of pediatrics, Mignot Hospital | Le Chesnay | 78150 | France | |||
| Department of pediatric pulmonology, Hopital Robert Debré |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16687711 | Background | Guilbert TW, Morgan WJ, Zeiger RS, Mauger DT, Boehmer SJ, Szefler SJ, Bacharier LB, Lemanske RF Jr, Strunk RC, Allen DB, Bloomberg GR, Heldt G, Krawiec M, Larsen G, Liu AH, Chinchilli VM, Sorkness CA, Taussig LM, Martinez FD. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med. 2006 May 11;354(19):1985-97. doi: 10.1056/NEJMoa051378. | |
| 10490528 |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Black screen | Other | A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child. |
|
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) |
| Paris |
| 75015 |
| France |
| Department of pediatric pulmonology, Necker Hospital | Paris | 75015 | France |
| Background |
| Iles R, Lister P, Edmunds AT. Crying significantly reduces absorption of aerosolised drug in infants. Arch Dis Child. 1999 Aug;81(2):163-5. doi: 10.1136/adc.81.2.163. |
| 23011563 | Background | Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25. |