Behavior Management Using Audiovisual Tools

May 6, 2021 updated by: Francisco Guinot-Jimeno, Universitat Internacional de Catalunya

Behavior Management Using Audiovisual Tools in Pediatric Dental Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each patient required a minimum of 2 visits for restorative treatment in a mandibular quadrant and had undergone a previous restorative dental experience. All parents or guardians of the children who participated in the study were informed about the study before enrolment, and gave their voluntary consent. Each visit lasted approximately 35 minutes and involved restorative treatment in a mandibular quadrant with an alveolar nerve block. The parents were not present in the operating room during the treatment. The maximum time between the 2 treatment sessions was 2 weeks. Before the start of each treatment session, as a part of the standard process of a paediatric dental visit, the child was given an explanation as to what the visit would comprise, with the aim of interrupting the treatment as little as possible. The children knew at the beginning of the first appointment (control) that they would be able to watch a movie or play a videogame during their next visit.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Universitat Internacional de Catalunya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 9 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 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 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 with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global behavior during the treatment
Time Frame: 14 days
14 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UIC-ODP-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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