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

NCT ID: NCT05191836

Last Updated: 2022-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2021-11-20

Brief Summary

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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

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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.

Conditions

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Pulpotomy Dental Caries Primary Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pulpotomy in primary mandibular molars by using video game distraction.

Group Type EXPERIMENTAL

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

Intervention Type 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 audio visual distraction.

Group Type EXPERIMENTAL

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

Intervention Type 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 without using any type of distraction aids

Group Type OTHER

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ekram M Al-sibai, DDs

Role: PRINCIPAL_INVESTIGATOR

MSc student in Pedodontics, University of Damascus

Nada G Bshara, Phd

Role: STUDY_DIRECTOR

Professor of Pedodontics, Department of Pedodontics, University of Damascus

Locations

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Damascus University

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 22730632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27222759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25416522 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16972829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29253180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32711948 (View on PubMed)

Other Identifiers

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UDDS-Pedo-08-2019

Identifier Type: -

Identifier Source: org_study_id

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