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Behavior Management Using Audiovisual Tools

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Francisco Guinot Jimeno, Universitat Internacional de Catalunya.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643915
First Posted: July 18, 2012
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Francisco Guinot Jimeno, Universitat Internacional de Catalunya
  Purpose
The aim of the study was to assess whether the behavior, anxiety, and pain of pediatric patients during dental treatment improves when a cartoon film is viewed or a videogame is played as methods of distraction.

Condition Intervention
Disruptive Global Behavior During Previous Treatment Visits Behavioral: No distraction method Behavioral: Distraction method

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Behavior Management Using Audiovisual Tools in Pediatric Dental Patients

Further study details as provided by Francisco Guinot Jimeno, Universitat Internacional de Catalunya:

Primary Outcome Measures:
  • Global behavior during the treatment [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Parental perception of patients' anxiety [ Time Frame: 14 days ]
  • Self-reported anxiety during the treatment [ Time Frame: 14 days ]
  • Pain during the treatment [ Time Frame: 14 days ]
  • Heart rate during the treatment measures in different time points [ Time Frame: 14 days ]
  • Degree of acceptance of the distraction method by the pediatric patient [ Time Frame: 14 days ]

Estimated Enrollment: 224
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control group
Patients with conventional treatment. No distraction method during the treatment visits.
Behavioral: No distraction method
Patients with conventional treatment. No distraction method during the treatment visits.
Experimental: Experimental group 1
Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.
Behavioral: Distraction method
Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.
Experimental: Experimental group 2
Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
Behavioral: Distraction method
Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 4-9 years.
  • Patients who required a minimum of 2 visits for restorative treatment.
  • Patients who had previously shown disruptive behavior (Frankl Behavior Rating Scale 1 or 2) during dental restorative treatment or pulp therapy.

Exclusion Criteria:

  • Patients with reduced audiovisual capabilities.
  • Patients with psychological disorders.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643915


Contacts
Contact: Francisco Guinot Jimeno, DDS, MsC 0034 93 504 50 00 fguinot79@hotmail.com

Locations
Spain
Universitat Internacional de Catalunya Recruiting
Sant Cugat del Vallès, Barcelona, Spain, 08195
Contact: Francisco Guinot Jimeno, DDS, MsC    0034 93 5045000    fguinot79@hotmail.com   
Principal Investigator: Francisco Guinot Jimeno, DDS, MsC         
Sponsors and Collaborators
Universitat Internacional de Catalunya
  More Information

Publications:
Responsible Party: Francisco Guinot Jimeno, DDS, MsC, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier: NCT01643915     History of Changes
Other Study ID Numbers: UIC-ODP-2
First Submitted: July 16, 2012
First Posted: July 18, 2012
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Francisco Guinot Jimeno, Universitat Internacional de Catalunya:
Audiovisual distraction
Pediatric dentistry