Effect of Television Cartoons in Patients Younger Than 3.5 Years During Echocardiography

NCT ID: NCT02498743

Last Updated: 2015-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-05-31

Brief Summary

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The objective of this study is analyze the influence of TV entertainment in children less than 3 years of age during echocardiography in order to achieve a complete and accurate test.

This is an experimental study in children with suspected congenital or acquired cardiac disease. An examination room was prepared with a TV on the ceiling that was positioned in a way that would provide unobstructed viewing for children during the echocardiography procedure.

Detailed Description

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Conditions

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Echocardiography Pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention group with television

Animated cartoons with sound were reproduced during the echocardiography

Group Type EXPERIMENTAL

echocardiography

Intervention Type PROCEDURE

TV was connected to display the cartoon video during the echocardiography: the episode number 125 of 'Dora the Explorer': 'Baby Winky Goes Home!' was reproduced during the echocardiography.

Watching Animated cartoons

Intervention Type BEHAVIORAL

control group with usual care

Echocardiography was performed by using the distractions available at the time of test.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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echocardiography

TV was connected to display the cartoon video during the echocardiography: the episode number 125 of 'Dora the Explorer': 'Baby Winky Goes Home!' was reproduced during the echocardiography.

Intervention Type PROCEDURE

Watching Animated cartoons

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients who were referred to pediatric cardiology consultation.
* Patients younger than 3.5 years.
* Signed informed consent by parents.

Exclusion Criteria

* No signed informed consent by parents.
Minimum Eligible Age

6 Months

Maximum Eligible Age

43 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

OTHER

Sponsor Role lead

Responsible Party

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Francisco Sánchez Ferrer

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Sanchez Ferrer, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Juan de Alicante

Locations

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Francisco Sánchez Ferrer

Sant Joan d'Alacant, Alicante, Spain

Site Status

Countries

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Spain

References

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Mertens L, Friedberg MK. The gold standard for noninvasive imaging in congenital heart disease: echocardiography. Curr Opin Cardiol. 2009 Mar;24(2):119-24. doi: 10.1097/HCO.0b013e328323d86f.

Reference Type BACKGROUND
PMID: 19225295 (View on PubMed)

Mertens L, Seri I, Marek J, Arlettaz R, Barker P, McNamara P, Moon-Grady AJ, Coon PD, Noori S, Simpson J, Lai WW; Writing Group of the American Society of Echocardiography; European Association of Echocardiography; Association for European Pediatric Cardiologists. Targeted Neonatal Echocardiography in the Neonatal Intensive Care Unit: practice guidelines and recommendations for training. Writing Group of the American Society of Echocardiography (ASE) in collaboration with the European Association of Echocardiography (EAE) and the Association for European Pediatric Cardiologists (AEPC). J Am Soc Echocardiogr. 2011 Oct;24(10):1057-78. doi: 10.1016/j.echo.2011.07.014. No abstract available.

Reference Type BACKGROUND
PMID: 21933743 (View on PubMed)

Heistein LC, Ramaciotti C, Scott WA, Coursey M, Sheeran PW, Lemler MS. Chloral hydrate sedation for pediatric echocardiography: physiologic responses, adverse events, and risk factors. Pediatrics. 2006 Mar;117(3):e434-41. doi: 10.1542/peds.2005-1445. Epub 2006 Feb 15.

Reference Type BACKGROUND
PMID: 16481449 (View on PubMed)

American Academy of Pediatrics; American Academy of Pediatric Dentistry; Cote CJ, Wilson S; Work Group on Sedation. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update. Paediatr Anaesth. 2008 Jan;18(1):9-10. doi: 10.1111/j.1460-9592.2007.02404.x. No abstract available.

Reference Type BACKGROUND
PMID: 18095958 (View on PubMed)

Other Identifiers

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2015-01

Identifier Type: -

Identifier Source: org_study_id

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