Evaluation of Audio-Visual Distraction Technique on Child... | NCT03229720

Studies
Evaluation of Audio-Visual Distraction Technique on Child's Anxiety

NCT03229720

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 25, 2017Actual

Enrollment

42Estimated

Phase

Not Applicable

Conditions

Anxiety, Dental
Fear, Dental

Interventions

Nibiru 3D Virtual Reality Headset

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Estimated

Primary Completion Date

Jul 1, 2018Estimated

Completion Date

Sep 1, 2018Estimated

First Submitted Date

Jul 23, 2017

First Submission Date that Met QC Criteria

Jul 24, 2017

First Posted Date

Jul 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2017

Last Update Posted Date

Jul 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sherif Adel Khalaf Zakhary, Principal Investigator, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market technology for adults and children. Some practitioners started using this modality of distraction in the dental practice to aid in psychological management of patients.

This study is designed to compare between conventional dental visits (No Distraction) and dental visits aided with audio-visual distraction. Providing a safe, comfortable and entertaining dental environment will give pediatric children a better perception regarding the dental environment and motivate them for repetitive dental visits for better dental health care.

Detailed Description

[I] Recruitment: Children aged 5~8 years old with teeth decay requiring restorative dental treatment will be randomly selected according to the Intrusion and Extrusion Criteria.

[II] Intervention:

-Steps:

The operator will select the teeth; child must have decayed tooth requiring restorative dental treatment.
The visit will be started by using the tell-show-do technique to explain the procedure. After that the Facial Image Scale is validated to assess dental anxiety and will be explained to the child. The dentist will ask the child to choose one of the six faces that best represented his/her current emotional state.
Pulse oximeter sensor will then be placed and initial pulse rate will be obtained.
Patient will choose from a bowl a piece of paper to decide if AV-distraction will be used or not.
Above steps will be done in both visits, with and without the intervention.
If the toss had AV-distraction, The operator will introduce the Audio-visual device (Virtual Reality Eye Glasses) to the patient and how it works and will allow the patient to choose his favorite show to watch during the dental visit.
The operator will instruct the patient with the rules that will be applied during the dental visit to assure complete cooperation.
The operator will apply topical and dental anaesthesia
Pulse rate will be measured every 5 minutes.
The operator will allow extra time if the dental visit ended before the child finishes the tv-show.
Then operator will ask the patient to choose from the face scale diagrams about his anxiety state at the end of the visit.

Intervention modifications:

In case the child interrupted the dental visit for questions or any reason, the last record of pulse oximeter will be repeated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Audio-Visual Distraction Group	Active Comparator	In this arm, the patient will be introduced to the audio-visual distraction device and given some instruction on how to use it and rules while using it. other than that, the dental procedure is as same as the other arm group.	Device: Nibiru 3D Virtual Reality Headset
Normal Dental Environment Group	No Intervention	Normal Dental Environment without any distractions.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nibiru 3D Virtual Reality Headset	Device	This device is a kind of head glass that obstructs the vision with a wide screen showing movies or photos. Earphones are extended from it and inserted in ears. so it obstructs the vision and audio of the surroundings.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Facial Image Scale	To measure dental Anxiety by using Facial Image Scale	Immediately right after the dental visit.

Secondary Outcomes

Measure	Description	Time Frame
Oxygen Saturation (using Pulse oximetry)	to assess the amount of oxygen saturation and relate to the stress level.	During the dental visit

Other Outcomes

Measure	Description	Time Frame
Heart Rate (using Pulse oximetry)	to asses heart beats per minute and relate it to the patient's anxiety	During the dental visit

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 5-8 years old.
Children with decayed teeth requiring pulp therapy (excluding cases with acute pulpitis)
Cooperative children and potentially cooperative
Physically and mentally normal children.
No previous dental experience involving local anaesthetic administration for the last 2 years

Exclusion Criteria:

Children with visual impairment.
Children with hearing disabilities.
Children with disability complicating the dental treatment as trismus, or TMJ problems.
Children with highly inflamed pulp tissue inducing pain during dental visit.
Patients or caregivers who refuse to sign the consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherif A Zakhary, B.D.S	Contact	+2001224579366		Sherif_zakhary@hotmail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Hamdy, Professor	Cairo University	Study Director
Nada Wassef, Ass. Prof	Cairo University	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided