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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05191836
• Other study ID #: UDDS-Pedo-08-2019
• Status: Completed
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: November 20, 2021

Study information

• Verified date: January 2022
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 20, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Primary Teeth
• Pulpotomy

Intervention

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.
• 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:
• 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.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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