Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications

NCT02879240 | Completed

• 1 other identifier: Distract01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

Patient Compliance; Inhalation Spacers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fraction of time during which the child is crying

  At the end of the three weeks (day 21)

• Fraction of time during which the child is moving outside the mask

  At the end of the three weeks (day 21)

Other Outcomes (1)

• Hetero-evaluation of the cooperation of the child by the parent

  At the end of the three weeks (day 21)

Study Arms (2)

Group animated cartoon-black screen (AB)

OTHER

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; Other: Black screen

Group black screen - animated cartoon (BA)

OTHER

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; Other: Black screen

Interventions

Animated Cartoon OTHER

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

Group animated cartoon-black screen (AB); Group black screen - animated cartoon (BA)

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.

Group animated cartoon-black screen (AB); Group black screen - animated cartoon (BA)

Eligibility Criteria

• Age: 6 Months - 47 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital Necker-Enfants Malades: lead

Study Sites (3)

Department of pediatrics, Mignot Hospital

Le Chesnay, 78150, France

Location

Department of pediatric pulmonology, Hopital Robert Debré

Paris, 75015, France

Location

Department of pediatric pulmonology, Necker Hospital

Paris, 75015, France

Location

Related 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. doi: 10.1056/NEJMoa051378.

  PMID: 16687711 BACKGROUND

• 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.

  PMID: 10490528 BACKGROUND

• 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.

  PMID: 23011563 BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• David Drummond, M.D.

  Necker hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 25, 2016
• Study Start: August 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: June 6, 2017

Record last verified: 2017-06

Locations

FR (3)