Clinical trial NCT02498743: Effect of Television Cartoons in Patients Younger Than 3.5 Years During Echocardiography
Official title: Effect of Television Cartoons in Patients Younger Than 3.5 Years During Echocardiography.A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Echocardiography
Pediatrics
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 58
Sex: ALL
Minimum age (years): 6
Maximum age (years): 43
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Echocardiography time
timeFrame: procedure
measure: Quality of technique
timeFrame: procedure
Secondary outcomes:
measure: Parents opinion
timeFrame: procedure
measure: Parents stress
timeFrame: procedure
measure: Blood pressure
timeFrame: procedure
Other outcomes:
Locations:
city: SAn Juan de Alicante
country: Spain
facility: Francisco Sánchez Ferrer
state: Alicante
Study officials:
affiliation: Hospital San Juan de Alicante
name: Francisco Sanchez Ferrer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.