Evaluation of Custom-designed Dental Storybook on the Den... | NCT06711367

Studies
Evaluation of Custom-designed Dental Storybook on the Dental Anxiety and Behavior of Children

NCT06711367

Sponsor

October University for Modern Sciences and Arts

Status

Not yet recruiting

Last Update Posted

Dec 2, 2024Actual

Enrollment

48Estimated

Phase

Not Applicable

Conditions

Child Behavior
Dental Anxiety

Interventions

tell show do behavior management technique
a costume-designed storybook

Countries

Egypt

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

Nov 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2024Estimated

Primary Completion Date

Mar 30, 2025Estimated

Completion Date

May 2, 2025Estimated

First Submitted Date

Nov 26, 2024

First Submission Date that Met QC Criteria

Nov 29, 2024

First Posted Date

Dec 2, 2024Actual

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

Nov 29, 2024

Last Update Posted Date

Dec 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Naglaa Ibrahim Ezz, Associate professor, October University for Modern Sciences and ArtsPrincipal Investigator

Lead Sponsor

October University for Modern Sciences and ArtsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Conventional behavior management techniques, namely: verbal communication and tell-show-do were used in the operatory for the participating children (Group A). The children allocated in intervention group (Group B) received a costume-designed storybook explaining the diagnosis and procedures of occlusal composite restoration

Detailed Description

Not provided

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

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tell show do behavior management technique	Active Comparator		Behavioral: tell show do behavior management technique
a costume-designed dental storybook	Experimental		Behavioral: a costume-designed storybook

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tell show do behavior management technique	Behavioral	tell show do behavior management technique about the the diagnosis and procedures of dental restoration	tell show do behavior management technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Child anxiety	Venham anxiety scale (score from 1-8)	through study completion, an average of four months

Secondary Outcomes

Measure	Description	Time Frame
Pulse rate	Pulse oximeter	through study completion, an average of four months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Healthy children and children/parents can read and understand Arabic.
- The child needs an occlusal composite restoration.

Exclusion Criteria:

Children with special needs; children with a complete audiovisual impairment; children with
Learning difficulties or mental retardation.
Children who are not Arabic speakers.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 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
Naglaa I Ezzeldin, Associate professor	Contact	+201001984184		niezz@msa.edu.eg
Radwa Y Khater, Lecturer	Contact	+20 122 743 2614		rkhater@msa.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
October University of Modern Sciences and Arts		Cairo			Egypt

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