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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 Universitat Internacional de Catalunya.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Francisco Guinot Jimeno, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier:
NCT01643915
First received: July 16, 2012
Last updated: May 26, 2014
Last verified: May 2014
  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

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: 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

Ages Eligible for Study:   4 Years to 9 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643915

Locations
Spain
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195
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: May 26, 2014
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 December 09, 2016