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

NCT05191836 | Completed

• 1 other identifier: UDDS-Pedo-08-2019
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulpotomy; Dental Caries; Primary Teeth

Keywords

Children's dental anxiety; video game

Outcome Measures

Primary Outcomes (2)

• 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

  20 minutes following the end of the treatment session

• 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.

  20 minutes following the end of the treatment session

Study Arms (3)

Pulpotomy in primary mandibular molars by using video game distraction.

EXPERIMENTAL

Behavioral: Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment

Pulpotomy in primary mandibular molars by using audio visual distraction.

EXPERIMENTAL

Behavioral: Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment

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

OTHER

Other: Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids

Interventions

Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment BEHAVIORAL

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.

Pulpotomy in primary mandibular molars by using video game distraction.

Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment BEHAVIORAL

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.

Pulpotomy in primary mandibular molars by using audio visual distraction.

Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids OTHER

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.

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

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 22730632 BACKGROUND

• 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.

  PMID: 27222759 BACKGROUND

• 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.

  PMID: 25416522 BACKGROUND

• 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.

  PMID: 16972829 BACKGROUND

• 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.

  PMID: 29253180 BACKGROUND

• 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.

  PMID: 32711948 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ekram M Al-sibai, DDs

  MSc student in Pedodontics, University of Damascus

  PRINCIPAL INVESTIGATOR

• Nada G Bshara, Phd

  Professor of Pedodontics, Department of Pedodontics, University of Damascus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 14, 2022
• Study Start: August 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: November 20, 2021
• Last Updated: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)