Clinical trial NCT02879240: Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications
Official title: Effectiveness of Animated Cartoons for Improving Cooperation During the Delivery of Inhaled Treatments to Young Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Inhalation Spacers
Lead sponsor: Hôpital Necker-Enfants Malades
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 11
Sex: ALL
Minimum age (years): 6
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fraction of time during which the child is non-cooperative
timeFrame: At the end of the three weeks (day 21)
Secondary outcomes:
measure: Fraction of time during which the child is crying
timeFrame: At the end of the three weeks (day 21)
measure: Fraction of time during which the child is moving outside the mask
timeFrame: At the end of the three weeks (day 21)
Other outcomes:
measure: Hetero-evaluation of the cooperation of the child by the parent
timeFrame: At the end of the three weeks (day 21)
Locations:
city: Le Chesnay
country: France
facility: Department of pediatrics, Mignot Hospital
city: Paris
country: France
facility: Department of pediatric pulmonology, Hopital Robert Debré
city: Paris
country: France
facility: Department of pediatric pulmonology, Necker Hospital
Study officials:
affiliation: Necker hospital
name: David Drummond, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.