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

November 29, 2024 updated by: Naglaa Ibrahim Ezz, October University for Modern Sciences and Arts

Comparative Evaluation of the Effectiveness of Custom-designed Dental Storybook Vs Tell Show Do on the Dental Anxiety and Behavior of Children: a Randomized Controlled Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Naglaa I Ezzeldin, Associate professor
  • Phone Number: +201001984184
  • Email: niezz@msa.edu.eg

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • October University of Modern Sciences and Arts
        • Contact:
          • Naglaa I Ezzeldin, Associate professor
          • Phone Number: +20 1001984184
          • Email: niezz@msa.edu.eg
        • Contact:
          • Radwa Y Khater, Lecturer
          • Phone Number: +20 122 743 2614
          • Email: rkhater@msa.eg
        • Contact:
          • Naglaa I Ezzeldin, Associate professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tell show do behavior management technique
Behavioral: tell show do behavior management technique
tell show do behavior management technique about the the diagnosis and procedures of dental restoration
Experimental: a costume-designed dental storybook
Behavioral: a costume-designed storybook
a costume-designed storybook explaining the diagnosis and procedures of dental restoration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October University for Modern Sciences and Arts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

May 2, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Estimated)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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