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

Sponsor
Damascus University (Other)
Overall Status
Completed
CT.gov ID
NCT05191836
Collaborator
(none)
105
1
3
3.2
32.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment
  • Behavioral: Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment
  • Other: Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Assessing an Active Distracting Technique During Pulpotomy in Primary Mandibular Molar.
Actual Study Start Date :
Aug 15, 2021
Actual Primary Completion Date :
Oct 15, 2021
Actual Study Completion Date :
Nov 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pulpotomy in primary mandibular molars by using video game distraction.

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.

Experimental: Pulpotomy in primary mandibular molars by using audio visual distraction.

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.

Other: Pulpotomy in primary mandibular molars without using any type of distraction aids

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.

Outcome Measures

Primary Outcome Measures

  1. Pain levels [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Damascus University Damascus Syrian Arab Republic

Sponsors and Collaborators

  • Damascus University

Investigators

  • Principal Investigator: Ekram M Al-sibai, DDs, MSc student in Pedodontics, University of Damascus
  • Study Director: Nada G Bshara, Phd, Professor of Pedodontics, Department of Pedodontics, University of Damascus

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Damascus University
ClinicalTrials.gov Identifier:
NCT05191836
Other Study ID Numbers:
  • UDDS-Pedo-08-2019
First Posted:
Jan 14, 2022
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Damascus University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022