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

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatrics; Echocardiography
• Intervention / Treatment: Procedure: echocardiography; Behavioral: Watching Animated cartoons

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • SAn Juan de Alicante, Alicante, Spain, 03550
      • Francisco Sánchez Ferrer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group with television; Animated cartoons with sound were reproduced during the echocardiography	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
No Intervention: control group with usual care; Echocardiography was performed by using the distractions available at the time of test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiography time	Time used to perform the Echocardiography	procedure
Quality of technique	The quality of echocardiography (1 poor, 2 medium, 3 high)	procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parents opinion	Parents completed a questionnaire about the use of TV during the test	procedure
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
Blood pressure	blood pressure of child	procedure

Collaborators and Investigators

• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Investigators: Principal Investigator: Francisco Sanchez Ferrer, MD, Hospital San Juan de Alicante

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2015-01