Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications

Patient Compliance Clinical Trial

— DISTRACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879240
• Other study ID #: Distract01
• Status: Completed
• Phase: N/A
• First received: August 16, 2016
• Last updated: June 5, 2017
• Start date: August 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: June 2017
• Source: Hôpital Necker-Enfants Malades
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 47 Months

Eligibility

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.

Related Conditions & MeSH terms

• Inhalation Spacers
• Patient Compliance

Intervention

Other:
• Animated Cartoon
An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.
• Black screen
A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.

Locations

Country	Name	City	State
France	Department of pediatrics, Mignot Hospital	Le Chesnay
France	Department of pediatric pulmonology, Hopital Robert Debré	Paris
France	Department of pediatric pulmonology, Necker Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Necker-Enfants Malades

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hetero-evaluation of the cooperation of the child by the parent		At the end of the three weeks (day 21)
Primary	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	At the end of the three weeks (day 21)
Secondary	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	At the end of the three weeks (day 21)
Secondary	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	At the end of the three weeks (day 21)