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

June 5, 2017 updated by: David Drummond, Hôpital Necker-Enfants Malades

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Chesnay, France, 78150
        • Department of pediatrics, Mignot Hospital
      • Paris, France, 75015
        • Department of pediatric pulmonology, Hopital Robert Debré
      • Paris, France, 75015
        • Department of pediatric pulmonology, Necker Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Animated Cartoon
An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.
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.
Other: 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.
Other: Animated Cartoon
An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of the three weeks (day 21)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of the three weeks (day 21)
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
At the end of the three weeks (day 21)

Other Outcome Measures

Outcome Measure
Time Frame
Hetero-evaluation of the cooperation of the child by the parent
Time Frame: At the end of the three weeks (day 21)
At the end of the three weeks (day 21)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Necker-Enfants Malades

Investigators

  • Principal Investigator: David Drummond, M.D., Necker Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Distract01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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