PulpotomyNCT05191836

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

A study testing Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment, Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment and Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids in people with Pulpotomy and Dental Caries, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 to 10 yearsHealthy volunteers can take part
Conditions the study is for: Pulpotomy, Dental Caries, Primary Teeth
What is being tested?: Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment, Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment and Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteSyria
Study dates: 15 Aug 2021to 20 Nov 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

previous dental experience
systematic or mental disorders.
definitely negative or negative ratings of Frankel scale
don't need of pulpotomy in temporary inferior molar

Trial locations and contacts

1 site in 1 country.

Syria1 site

Damascus University
Damascus

Other trials in Syria

About this study

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

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).

Read the 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.

Conditions: Pulpotomy, Dental Caries, Primary Teeth
Being tested: Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment, Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment, Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids
Keywords: Children's dental anxiety, video game
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatmentBehavioural
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 treatmentBehavioural
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 aidsOther
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.

Study groups in NCT05191836
Study group	Role	What they receive
Pulpotomy in primary mandibular molars by using video game distraction.	Experimental	Not described Receives: Behavioral: Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment
Pulpotomy in primary mandibular molars by using audio visual distraction.	Experimental	Not described Receives: Behavioral: Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment
Pulpotomy in primary mandibular molars without using any type of distraction aids	Other	Not described Receives: Other: Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain levels
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
Measured: 20 minutes following the end of the treatment session
Anxiety levels
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.
Measured: 20 minutes following the end of the treatment session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 202120 Nov 2021

First posted14 Jan 2022
Study start15 Aug 2021
Primary completion15 Oct 2021
Study completion20 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for PulpotomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05191836
Sponsor's protocol ID: UDDS-Pedo-08-2019
Status last verified: Jan 2022
First submitted: 14 Dec 2021
Last updated: 14 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 22730632
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.
PubMed 27222759
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.
PubMed 25416522
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.
PubMed 16972829
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.
PubMed 29253180
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.
PubMed 32711948

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Short Term Comparative Assessment of MTA and Biodentine in Complete Pulpotomy for Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis (SIP)
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
Not yet recruiting
Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate)
Periapical Healing
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis

All Pulpotomy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing an Active Distracting Technique During Pulpotomy in Primary Mandibular Molar.
ClinicalTrials.gov ID: NCT05191836
Acronym / sponsor ID: UDDS-Pedo-08-2019
Conditions: Pulpotomy, Dental Caries, Primary Teeth
Keywords: Children's dental anxiety, video game
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 15 Aug 2021 (actual)
Primary completion: 15 Oct 2021 (actual)
Study completion: 20 Nov 2021 (actual)
First posted: 14 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Pulpotomy in primary mandibular molars by using video game distraction.	Experimental	Behavioral: Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatment
Pulpotomy in primary mandibular molars by using audio visual distraction.	Experimental	Behavioral: Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatment
Pulpotomy in primary mandibular molars without using any type of distraction aids	Other	Other: Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aids

Who may qualify

Ages: 6 to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

previous dental experience
systematic or mental disorders.
definitely negative or negative ratings of Frankel scale
don't need of pulpotomy in temporary inferior molar

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Evaluation of the effectiveness of Video Game Distraction in the management of anxious pediatric patients during dental treatmentThe 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.	Behavioural	Pulpotomy in primary mandibular molars by using video game distraction.
Evaluation of the effectiveness of Audio Video Distraction in the management of anxious pediatric patients during dental treatmentThe 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.	Behavioural	Pulpotomy in primary mandibular molars by using audio visual distraction.
Evaluation of the anxiety in pediatric patients during dental treatment without using any type of distraction aidsThe 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.	Other	Pulpotomy in primary mandibular molars without using any type of distraction aids

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
Background: PubMed 22730632Minute 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.
Background: PubMed 27222759Abdelmoniem 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.
Background: PubMed 25416522Attar 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.
Background: PubMed 16972829Patel 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.
Background: PubMed 29253180Millett 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.
Background: PubMed 32711948Arikan 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.
Individual participant dataSharing planned: No

Related trials for Pulpotomy

Recruiting
Short Term Comparative Assessment of MTA and Biodentine in Complete Pulpotomy for Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis (SIP)
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
Not yet recruiting
Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate)
Periapical Healing
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ekram M Al-sibai, DDs principal investigator

MSc student in Pedodontics, University of Damascus

Nada G Bshara, Phd study director

Professor of Pedodontics, Department of Pedodontics, University of Damascus

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain levels (time frame: 20 minutes following the end of the treatment session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05191836, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.