Child BehaviorNCT06711367
Evaluation of Custom-designed Dental Storybook on the Dental Anxiety and Behavior of Children
A study testing tell show do behavior management technique and a costume-designed storybook in people with Child Behavior and Dental Anxiety, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior, Dental Anxiety
- What is being tested?
- tell show do behavior management technique and a costume-designed storybook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 2 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Healthy children and children/parents can read and understand Arabic.
- The child needs an occlusal composite restoration.
Who cannot join
- Children with special needs; children with a complete audiovisual impairment; children with
- Learning difficulties or mental retardation.
- Children who are not Arabic speakers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
October University of Modern Sciences and Arts
Cairo
Naglaa I Ezzeldin, Associate professor, +20 1001984184, niezz@msa.edu.eg
Radwa Y Khater, Lecturer, +20 122 743 2614, rkhater@msa.eg
About this study
Official title: 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
- Conditions
- Child Behavior, Dental Anxiety
- Being tested
- tell show do behavior management technique, a costume-designed storybook
- Keywords
- dental storybook, tell show do, dental anxiety
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tell show do behavior management techniqueBehavioural
tell show do behavior management technique about the the diagnosis and procedures of dental restoration
a costume-designed storybookBehavioural
a costume-designed storybook explaining the diagnosis and procedures of dental restoration
| Study group | Role | What they receive |
|---|---|---|
| tell show do behavior management technique | Active comparator | Not described Receives: Behavioral: tell show do behavior management technique |
| a costume-designed dental storybook | Experimental | Not described Receives: Behavioral: a costume-designed storybook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child anxiety
Venham anxiety scale (score from 1-8)
Measured: through study completion, an average of four months
Secondary outcomes (1)
Pulse rate
Pulse oximeter
Measured: through study completion, an average of four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion2 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Ibrahim Ezz, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711367
- Sponsor's protocol ID
- REC-D
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06711367
- Acronym / sponsor ID
- REC-D
- Conditions
- Child Behavior, Dental Anxiety
- Keywords
- dental storybook, tell show do, dental anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 2 May 2025 (estimated)
- First posted
- 2 Dec 2024 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- • Healthy children and children/parents can read and understand Arabic.
Key exclusion criteria (3 listed)
- Children with special needs; children with a complete audiovisual impairment; children with
- Learning difficulties or mental retardation.
- Children who are not Arabic speakers.
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 |
|---|---|---|
| tell show do behavior management techniquetell show do behavior management technique about the the diagnosis and procedures of dental restoration | Behavioural | tell show do behavior management technique |
| a costume-designed storybooka costume-designed storybook explaining the diagnosis and procedures of dental restoration | Behavioural | a costume-designed dental storybook |
Primary outcome
Child anxiety
Time frame: through study completion, an average of four months
Venham anxiety scale (score from 1-8)
1 secondary outcome
Pulse rate
Time frame: through study completion, an average of four months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Child Behavior
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
Study of Psychoeducation and Reading for Kids (SPARK)
Reading Difficulties, Behavioral Problems
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tell show do behavior management technique and a costume-designed storybook in people with Child Behavior and Dental Anxiety, run by October University for Modern Sciences and Arts at 1 site in Egypt.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 2 Dec 2024. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naglaa I Ezzeldin, Associate professor (+201001984184, niezz@msa.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child anxiety (time frame: through study completion, an average of four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2024.