Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications (DISTRACT)

Hôpital Necker-Enfants Malades

Status: Completed

Conditions: Inhalation Spacers; Patient Compliance

Treatments: Other: Black screen; Other: Animated Cartoon

Study type: Interventional

Funder types: Other

Identifiers

NCT02879240

Distract01

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 6 to 47 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Group animated cartoon-black screen (AB)

Other group

Description:

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.

Treatment:

Other: Animated Cartoon

Other: Black screen

Group black screen - animated cartoon (BA)

Other group

Description:

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.

Treatment:

Other: Animated Cartoon

Other: Black screen