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

Primary Purpose

Patient Compliance, Inhalation Spacers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Animated Cartoon
Black screen
Sponsored by
Hôpital Necker-Enfants Malades
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Patient Compliance

Eligibility Criteria

6 Months - 47 Months (Child)All SexesAccepts 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.

Sites / Locations

  • Department of pediatrics, Mignot Hospital
  • Department of pediatric pulmonology, Hopital Robert Debré
  • Department of pediatric pulmonology, Necker Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group animated cartoon-black screen (AB)

Group black screen - animated cartoon (BA)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Fraction of time during which the child is non-cooperative
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 Outcome Measures

Fraction of time during which the child is crying
Length of time during which the child is crying divided by the total length of time needed for the delivery of the inhaled treatment
Fraction of time during which the child is moving outside the mask
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

Full Information

First Posted
August 16, 2016
Last Updated
June 5, 2017
Sponsor
Hôpital Necker-Enfants Malades
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1. Study Identification

Unique Protocol Identification Number
NCT02879240
Brief Title
Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications
Acronym
DISTRACT
Official Title
Effectiveness of Animated Cartoons for Improving Cooperation During the Delivery of Inhaled Treatments to Young Children With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Necker-Enfants Malades

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Compliance, Inhalation Spacers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group animated cartoon-black screen (AB)
Arm Type
Other
Arm 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.
Arm Title
Group black screen - animated cartoon (BA)
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Animated Cartoon
Intervention Description
An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.
Intervention Type
Other
Intervention Name(s)
Black screen
Intervention Description
A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.
Primary Outcome Measure Information:
Title
Fraction of time during which the child is non-cooperative
Description
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
Time Frame
At the end of the three weeks (day 21)
Secondary Outcome Measure Information:
Title
Fraction of time during which the child is crying
Description
Length of time during which the child is crying divided by the total length of time needed for the delivery of the inhaled treatment
Time Frame
At the end of the three weeks (day 21)
Title
Fraction of time during which the child is moving outside the mask
Description
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
Time Frame
At the end of the three weeks (day 21)
Other Pre-specified Outcome Measures:
Title
Hetero-evaluation of the cooperation of the child by the parent
Time Frame
At the end of the three weeks (day 21)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Drummond, M.D.
Organizational Affiliation
Necker hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of pediatrics, Mignot Hospital
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Department of pediatric pulmonology, Hopital Robert Debré
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Department of pediatric pulmonology, Necker Hospital
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16687711
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.
Results Reference
background
PubMed Identifier
10490528
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.
Results Reference
background
PubMed Identifier
23011563
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.
Results Reference
background

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Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications

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