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Completed

NCT Number: NCT05191836

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

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).

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Key information

Conditions

Pulpotomy Dental Caries Primary Teeth Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2022
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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