Clinical trial NCT05191836: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulpotomy
Dental Caries
Primary Teeth
Keywords: Children's dental anxiety
video game
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 105
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain levels
timeFrame: 20 minutes following the end of the treatment session
measure: Anxiety levels
timeFrame: 20 minutes following the end of the treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: MSc student in Pedodontics, University of Damascus
name: Ekram M Al-sibai, DDs
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pedodontics, Department of Pedodontics, University of Damascus
name: Nada G Bshara, Phd
role: STUDY_DIRECTOR
References:
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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.
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.
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.
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.
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.