search
Back to results

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

Primary Purpose

Pulpotomy, Dental Caries, Primary Teeth

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment
Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment
Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpotomy focused on measuring Children's dental anxiety, video game

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Pulpotomy in primary mandibular molars by using video game distraction.

Pulpotomy in primary mandibular molars by using audio visual distraction.

Pulpotomy in primary mandibular molars without using any type of distraction aids

Arm Description

Outcomes

Primary Outcome Measures

Pain levels
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
Anxiety levels
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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2021
Last Updated
January 10, 2022
Sponsor
Damascus University
search

1. Study Identification

Unique Protocol Identification Number
NCT05191836
Brief Title
Pain and Anxiety Reducing During Dental Treatment in Children Using Video Game on Tablet Device With Joystick.
Official Title
Assessing an Active Distracting Technique During Pulpotomy in Primary Mandibular Molar.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpotomy, Dental Caries, Primary Teeth
Keywords
Children's dental anxiety, video game

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulpotomy in primary mandibular molars by using video game distraction.
Arm Type
Experimental
Arm Title
Pulpotomy in primary mandibular molars by using audio visual distraction.
Arm Type
Experimental
Arm Title
Pulpotomy in primary mandibular molars without using any type of distraction aids
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain levels
Description
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
Time Frame
20 minutes following the end of the treatment session
Title
Anxiety levels
Description
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.
Time Frame
20 minutes following the end of the treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age between 6 and 10 years. no previous dental experience. definitely positive or positive ratings of Frank scale. Need of pulpotomy in temporary inferior molar. Exclusion Criteria: previous dental experience systematic or mental disorders. definitely negative or negative ratings of Frankel scale don't need of pulpotomy in temporary inferior molar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekram M Al-sibai, DDs
Organizational Affiliation
MSc student in Pedodontics, University of Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nada G Bshara, Phd
Organizational Affiliation
Professor of Pedodontics, Department of Pedodontics, University of Damascus
Official's Role
Study Director
Facility Information:
Facility Name
Damascus University
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22730632
Citation
Minute M, Badina L, Cont G, Montico M, Ronfani L, Barbi E, Ventura A. Videogame playing as distraction technique in course of venipuncture. Pediatr Med Chir. 2012 Mar-Apr;34(2):77-83. doi: 10.4081/pmc.2012.64.
Results Reference
background
PubMed Identifier
27222759
Citation
Abdelmoniem SA, Mahmoud SA. Comparative evaluation of passive, active, and passive-active distraction techniques on pain perception during local anesthesia administration in children. J Adv Res. 2016 May;7(3):551-6. doi: 10.1016/j.jare.2015.10.001. Epub 2015 Oct 19.
Results Reference
background
PubMed Identifier
25416522
Citation
Attar RH, Baghdadi ZD. Comparative efficacy of active and passive distraction during restorative treatment in children using an iPad versus audiovisual eyeglasses: a randomised controlled trial. Eur Arch Paediatr Dent. 2015 Feb;16(1):1-8. doi: 10.1007/s40368-014-0136-x. Epub 2014 Nov 22.
Results Reference
background
PubMed Identifier
16972829
Citation
Patel A, Schieble T, Davidson M, Tran MC, Schoenberg C, Delphin E, Bennett H. Distraction with a hand-held video game reduces pediatric preoperative anxiety. Paediatr Anaesth. 2006 Oct;16(10):1019-27. doi: 10.1111/j.1460-9592.2006.01914.x.
Results Reference
background
PubMed Identifier
29253180
Citation
Millett CR, Gooding LF. Comparing Active and Passive Distraction-Based Music Therapy Interventions on Preoperative Anxiety in Pediatric Patients and Their Caregivers. J Music Ther. 2018 Jan 13;54(4):460-478. doi: 10.1093/jmt/thx014.
Results Reference
background
PubMed Identifier
32711948
Citation
Arikan A, Esenay FI. Active and Passive Distraction Interventions in a Pediatric Emergency Department to Reduce the Pain and Anxiety During Venous Blood Sampling: A Randomized Clinical Trial. J Emerg Nurs. 2020 Nov;46(6):779-790. doi: 10.1016/j.jen.2020.05.004. Epub 2020 Jul 22.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs