Patient ComplianceDISTRACTNCT02879240
Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications
A study testing Animated Cartoon and Black screen in people with Patient Compliance and Inhalation Spacers, run by Hôpital Necker-Enfants Malades at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 47 monthsHealthy volunteers can take part
- Conditions the study is for
- Patient Compliance, Inhalation Spacers
- What is being tested?
- Animated Cartoon and Black screen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesFrance
- Study dates
- Aug 2016to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 47 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Department of pediatrics, Mignot Hospital
Le Chesnay, 78150
Department of pediatric pulmonology, Hopital Robert Debré
Paris, 75015
Department of pediatric pulmonology, Necker Hospital
Paris, 75015
About this study
Official title: 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.
- Conditions
- Patient Compliance, Inhalation Spacers
- Being tested
- Animated Cartoon, Black screen
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animated CartoonOther
An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.
Black screenOther
A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Animated Cartoon; Other: Black screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of the three weeks (day 21)
Secondary outcomes (2)
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
Measured: At the end of the three weeks (day 21)
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
Measured: At the end of the three weeks (day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Necker-Enfants Malades
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Drummond, Hôpital Necker-Enfants Malades
- Investigators
- David Drummond, M.D., Principal investigator, Necker hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879240
- Sponsor's protocol ID
- Distract01
- Acronym
- DISTRACT
- Status last verified
- Jun 2017
- First submitted
- 16 Aug 2016
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16687711Iles 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.
PubMed 10490528Lee 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.
PubMed 23011563
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Animated Cartoons for Improving Cooperation During the Delivery of Inhaled Treatments to Young Children With Asthma
- ClinicalTrials.gov ID
- NCT02879240
- Acronym / sponsor ID
- DISTRACT / Distract01
- Conditions
- Patient Compliance, Inhalation Spacers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hôpital Necker-Enfants MaladesUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group animated cartoon-black screen (AB) | Other | Other: Animated Cartoon, Other: Black screenIn 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. |
| Group black screen - animated cartoon (BA) | Other | Other: Animated Cartoon, Other: Black screenIn 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. |
Who may qualify
- Ages
- 6 to 47 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animated CartoonAn animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child. | Other | Group animated cartoon-black screen (AB), Group black screen - animated cartoon (BA) |
| Black screenA video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child. | Other | Group animated cartoon-black screen (AB), Group black screen - animated cartoon (BA) |
Primary outcome
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
2 secondary outcomes
Fraction of time during which the child is crying
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Background: PubMed 16687711Guilbert 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.
- Background: PubMed 10490528Iles 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.
- Background: PubMed 23011563Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Drummond, M.D. principal investigator
Necker hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animated Cartoon and Black screen in people with Patient Compliance and Inhalation Spacers, run by Hôpital Necker-Enfants Malades at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of time during which the child is non-cooperative (time frame: At the end of the three weeks (day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02879240, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.