Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-03-31

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.

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Detailed Description

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Conditions

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Patient Compliance Inhalation Spacers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group animated cartoon-black screen (AB)

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 Type OTHER

Animated Cartoon

Intervention Type OTHER

An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.

Black screen

Intervention Type OTHER

A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.

Group black screen - animated cartoon (BA)

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.

Group Type OTHER

Animated Cartoon

Intervention Type OTHER

An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.

Black screen

Intervention Type OTHER

A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.

Interventions

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Animated Cartoon

An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.

Intervention Type OTHER

Black screen

A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.

Intervention Type OTHER

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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

47 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes