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

Pediatrics Clinical Trial

Official title:

Effect of Television Cartoons in Patients Younger Than 3.5 Years During Echocardiography.A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498743
• Other study ID #: 2015-01
• Status: Completed
• Phase: N/A
• First received: July 10, 2015
• Last updated: July 14, 2015
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 43 Months

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Echocardiography
• Pediatrics

Intervention

Procedure:
• 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.

Behavioral:
• Watching Animated cartoons

Locations

Country	Name	City	State
Spain	Francisco Sánchez Ferrer	SAn Juan de Alicante	Alicante

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (4)

American Academy of Pediatrics; American Academy of Pediatric Dentistry, Coté 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. — View 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. Epub 2006 Feb 15. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiography time	Time used to perform the Echocardiography	procedure	No
Primary	Quality of technique	The quality of echocardiography (1 poor, 2 medium, 3 high)	procedure	No
Secondary	Parents opinion	Parents completed a questionnaire about the use of TV during the test	procedure	No
Secondary	Parents stress	The parent's opinion about the sensation of stress by using a scale from 0 (no stress) to 10 (so much stress	procedure	No
Secondary	Blood pressure	blood pressure of child	procedure	No