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Behavior Management Using Audiovisual Tools

This study is not yet open for participant recruitment.
Verified July 2012 by Universitat Internacional de Catalunya
Sponsor:
Information provided by (Responsible Party):
Francisco Guinot Jimeno, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier:
NCT01643915
First received: July 16, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  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: Open Label
Official Title: Behavior Management Using Audiovisual Tools in Pediatric Dental Patients

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Eye Wear
U.S. FDA Resources

Further study details as provided by Universitat Internacional de Catalunya:

Primary Outcome Measures:
  • Global behavior during the treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parental perception of patients' anxiety [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Self-reported anxiety during the treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Pain during the treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Heart rate during the treatment measures in different time points [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Degree of acceptance of the distraction method by the pediatric patient [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2012 (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 first 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 first treatment visit.
Experimental: Experimental group 2
Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the first treatment visit.
 Behavioral: Distraction method
Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the first treatment visit.
Experimental: Experimental group 3
Patients will play with the PlayStation® video game adapted with Rimax® multimedia eyeglasses that occlude the environment partially during the first treatment visit.
 Behavioral: Distraction method
Patients will play with the PlayStation® video game adapted with Rimax® multimedia eyeglasses that occlude the environment partially during the first treatment visit.
Experimental: Experimental group 4
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 5
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.
Experimental: Experimental group 6
Patients will play with the PlayStation® video game adapted with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
 Behavioral: Distraction method
Patients will play with the PlayStation® video game adapted with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

  Eligibility

Ages Eligible for Study:   4 Years to 9 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643915

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

Locations
Spain
Universitat Internacional de Catalunya Not yet 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
Study First Received: July 16, 2012
Last Updated: July 16, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universitat Internacional de Catalunya:
Audiovisual distraction
Pediatric dentistry

ClinicalTrials.gov processed this record on May 22, 2013