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Clinical Trials/NCT05191836
NCT05191836
Completed
Not Applicable

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

Damascus University1 site in 1 country105 target enrollmentAugust 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulpotomy
Sponsor
Damascus University
Enrollment
105
Locations
1
Primary Endpoint
Pain levels
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2021
End Date
November 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Pain levels

Time Frame: 20 minutes following the end of the treatment session

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

Time Frame: 20 minutes following the end of the treatment session

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.

Study Sites (1)

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