NCT06711367

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 26, 2024

Last Update Submit

November 29, 2024

Conditions

Keywords

dental storybooktell show dodental anxiety

Outcome Measures

Primary Outcomes (1)

  • Child anxiety

    Venham anxiety scale (score from 1-8)

    through study completion, an average of four months

Secondary Outcomes (1)

  • Pulse rate

    through study completion, an average of four months

Study Arms (2)

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

tell show do behavior management technique about the the diagnosis and procedures of dental restoration

tell show do behavior management technique

a costume-designed storybook explaining the diagnosis and procedures of dental restoration

a costume-designed dental storybook

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October University of Modern Sciences and Arts

Cairo, Egypt

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Naglaa I Ezzeldin, Associate professor

CONTACT

Radwa Y Khater, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 26, 2024

First Posted

December 2, 2024

Study Start

December 1, 2024

Primary Completion

March 30, 2025

Study Completion

May 2, 2025

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations