Pain and Anxiety Reducing During Dental Treatment in Children Using Video Game on Tablet Device With Joystick.

January 10, 2022 updated by: Damascus University

Assessing an Active Distracting Technique During Pulpotomy in Primary Mandibular Molar.

The aim of this study is to evaluate the effectiveness of two different distraction techniques (Audio Video Distraction /Video Game Distraction) in the management of anxious pediatric patients during dental treatment.

Group A: pulpotomy in temporary inferior molar will be treated with using video game on tablet device with wireless joystick and wireless headphone

Group B: pulpotomy in temporary inferior molar will be treated with using AV tablet and wireless headphone.

Group C (Control group): pulpotomy in temporary inferior molar will be treated with basic behavior guidance techniques and without using any type of distraction aids.

All of the children who experienced a pulpotomy in temporary inferior molar with/without distraction will be assessed by using a combination of measures: Simplified Wong-Baker faces(self-report), and "HOUPT" Behavior Rating Scale for Movement - Crying - Overall Behavior (nonself-report).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the effectiveness of two types of distraction aids that contain video game on tablet device with wireless (joystick and headphone) along with audio video distraction using tablet device and wireless headphone.

Pain and anxiety will be evaluated during pulpotomy in temporary inferior molar using two behavioral scales, Simplified Wong-Baker faces (self-report), and "HOUPT" Behavior Rating Scale for Movement - Crying - Overall Behavior (nonself-report).

The Behavior Rating Scale "HOUPT" will be measured four times: directly when the patient seated comfortably on the dental chair, after anesthesia, after pulpotomy, and when the treatment completed.

All child patients will ask to choose a face that describe their status from one of the Simplified Wong Baker faces scale in the same four times.

Study Type

Interventional

Enrollment (Actual)

105

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

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 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age between 6 and 10 years.
  2. no previous dental experience.
  3. definitely positive or positive ratings of Frank scale.
  4. Need of pulpotomy in temporary inferior molar.

Exclusion Criteria:

  1. previous dental experience
  2. systematic or mental disorders.
  3. definitely negative or negative ratings of Frankel scale
  4. don't need of pulpotomy in temporary inferior molar

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulpotomy in primary mandibular molars by using video game distraction.
Behavioral: Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment

The child will be provided dental treatment during watching video game.The Behavior Rating Scale "HOUPT" will be measured four times: directly when the patient seated comfortably on the dental chair, after anesthesia, after pulpotomy, and when the treatment completed.

All child patients will ask to choose a face that describe their status from one of the Simplified Wong Baker faces scale in the same four times.
Experimental: Pulpotomy in primary mandibular molars by using audio visual distraction.
Behavioral: Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment

The child will be provided dental treatment during audio video distraction.The Behavior Rating Scale "HOUPT" will be measured four times: directly when the patient seated comfortably on the dental chair, after anesthesia, after pulpotomy, and when the treatment completed.

The child will be provided dental treatment during watching video game. All child patients will ask to choose a face that describe their status from one of the Simplified Wong Baker faces scale in the same four times.
Other: Pulpotomy in primary mandibular molars without using any type of distraction aids
Other: Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids

The child will be provided dental treatment without using any type of distraction aids.The Behavior Rating Scale "HOUPT" will be measured four times: directly when the patient seated comfortably on the dental chair, after anesthesia, after pulpotomy, and when the treatment completed.

The child will be provided dental treatment during watching video game. All child patients will ask to choose a face that describe their status from one of the Simplified Wong Baker faces scale in the same four times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain levels
Time Frame: 20 minutes following the end of the treatment session

Pain levels will be measured by using a self-reported simplified Wong-Baker faces pain scale:

0 no pain - 1 mild pain - 2 moderate pain - 3 worst pain
20 minutes following the end of the treatment session
Anxiety levels
Time Frame: 20 minutes following the end of the treatment session

Anxiety levels will be measured by using the "HOUPT" Behavior Rating Scale for Movement - Crying - Overall Behavior:

For movement: 1 violent movement - 2 continuous movement - 3 controllable movement - 4 no movement.

For crying: 1 hysterical crying - 2 continuous crying - 3 mild crying - 4 no crying.

For overall behavior: 1 no treatment - 2 treatment interrupted, only partial treatment completed - 3 treatment interrupted, but eventually all completed - 4 difficult, but all treatment performed - 5 some limited crying or movement - 6 no crying or movement.
20 minutes following the end of the treatment session

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Principal Investigator: Ekram M Al-sibai, DDs, MSc student in Pedodontics, University of Damascus

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 (Actual)

August 15, 2021

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

November 20, 2021

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-08-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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