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

Not Applicable

Completed

• Conditions: Echocardiography; Pediatrics
• Interventions: Procedure: echocardiography; Behavioral: Watching Animated cartoons

• Registration Number: NCT02498743
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-14
• Last Update Submitted: 2015-07-14
• Study First Posted: 2015-07-15
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group with television	Watching Animated cartoons	Animated cartoons with sound were reproduced during the echocardiography
Intervention group with television	echocardiography	Animated cartoons with sound were reproduced during the echocardiography

Primary Outcome Measures

Name	Time	Method
Echocardiography time	procedure	Time used to perform the Echocardiography
Quality of technique	procedure	The quality of echocardiography (1 poor, 2 medium, 3 high)

Secondary Outcome Measures

Name	Time	Method
Blood pressure	procedure	blood pressure of child
Parents opinion	procedure	Parents completed a questionnaire about the use of TV during the test
Parents stress	procedure	The parent's opinion about the sensation of stress by using a scale from 0 (no stress) to 10 (so much stress

Trial Locations

Locations (1)

Francisco Sánchez Ferrer; 🇪🇸 SAn Juan de Alicante, Alicante, Spain