NCT02498743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

July 10, 2015

Last Update Submit

July 14, 2015

Conditions

EchocardiographyPediatrics

Outcome Measures

Primary Outcomes (2)

  • Echocardiography time

    Time used to perform the Echocardiography

    procedure

  • Quality of technique

    The quality of echocardiography (1 poor, 2 medium, 3 high)

    procedure

Secondary Outcomes (3)

  • Parents opinion

    procedure

  • Parents stress

    procedure

  • Blood pressure

    procedure

Study Arms (2)

Intervention group with television

EXPERIMENTAL

Animated cartoons with sound were reproduced during the echocardiography

Procedure: echocardiographyBehavioral: Watching Animated cartoons

control group with usual care

NO INTERVENTION

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

Interventions

echocardiographyPROCEDURE

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 group with television
Watching Animated cartoonsBEHAVIORAL
Intervention group with television

Eligibility Criteria

Age6 Months - 43 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • No signed informed consent by parents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisco Sánchez Ferrer

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

Related Publications (4)

  • 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.

    PMID: 19225295BACKGROUND

  • 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.

    PMID: 21933743BACKGROUND

  • 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.

    PMID: 16481449BACKGROUND

  • 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.

    PMID: 18095958BACKGROUND

Study Officials

  • Francisco Sanchez Ferrer, MD

    Hospital San Juan de Alicante

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 10, 2015

First Posted

July 15, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations

ES(1)