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Completed

NCT Number: NCT02879240

Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications

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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Key information

Conditions

Patient Compliance Behavior Health Behavior Inhalation Spacers Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

6 month–47 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of pediatrics, Mignot Hospital, Le Chesnay, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Animated Cartoon

Other

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

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.

Primary outcomes

  1. Fraction of time during which the child is non-cooperative

    Time frame: 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 outcomes

  1. Fraction of time during which the child is crying

    Time frame: 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

  2. Fraction of time during which the child is moving outside the mask

    Time frame: 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 outcomes

  1. Hetero-evaluation of the cooperation of the child by the parent

    Time frame: At the end of the three weeks (day 21)

Sponsors and collaborators

Lead sponsor

Hôpital Necker-Enfants Malades

Other

Registry information

Official study title

Effectiveness of Animated Cartoons for Improving Cooperation During the Delivery of Inhaled Treatments to Young Children With Asthma

Acronym: DISTRACT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 25, 2016
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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