Effect of PlayStation Distraction in the Dental Setting

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

Effect of PlayStation Distraction on Children's Behavior and Pain in the Dental Setting

The aim of the study was to assess whether the behavior, anxiety, and dental pain of pediatric patients during dental treatment improves when a video game is played as method of distraction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

global behavior Parental perception of patients' anxiety Patient's anxiety dental pain Heart Rate

Study Type

Interventional

Enrollment (Actual)

34

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 Valles, 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

6 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 6-8 years.
  • Patients who required a minimum of 2 visits for restorative treatment.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
Behavioral: Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
videogame can be considered as a method of distraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global behavior during the treatment
Time Frame: 14 days
we will use the Frankl Scale
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental perception of patient's anxiety
Time Frame: 14 days
we will use the Modified Corah Anxiety Scale Questionnaire
14 days
Self-reported anxiety during the treatment
Time Frame: 14 days
we will use the Venham Picture Test
14 days
Dental pain during the treatment
Time Frame: 14 days
We will use the Wong-Baker Faces Scale
14 days
Heart rate during the treatment measures in different time points
Time Frame: 14 days
We will use the the pulse oximeter
14 days
Degree of acceptance of the distraction method by the pediatric patient
Time Frame: 14 days
"Did you enjoy seeing the cartoon film during the dental visit?" (Yes/No)
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

June 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 2, 2014

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-3

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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