Dental AnxietyPuppetsNCT07034833
Assessment of a Ventriloquist Puppet for Reducing Dental Anxiety in Children
A study testing Ventriloquist Puppet Interaction in people with Dental Anxiety, run by Al-Azhar University.
Trial summary
thhe goal of this clinical trial is to assess the effect of ventriloquist puppets to reduce the strees accompined by the dental visit in cgilren . The main questions it aims to answer are: Does the ventriloquist puppet can reduce the stress accompanied by the dental visit for the children ? What medical problems do… Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Ventriloquist Puppet Interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2025to 10 Jul 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children with no systemic diseases.
- children require dental intervention
Who cannot join
- children with bad dental experience
- children require invasive surgical intervention
About this study
thhe goal of this clinical trial is to assess the effect of ventriloquist puppets to reduce the strees accompined by the dental visit in cgilren . The main questions it aims to answer are:
- Does the ventriloquist puppet can reduce the stress accompanied by the dental visit for the children ?
- What medical problems do participants have when taking drug ABC? Researchers will compare ventriloquist puppet to a control group (conventional behavior management techniques ) to see if ventriloquist puppet can lower the anxiety or not.
- Conditions
- Dental Anxiety
- Being tested
- Ventriloquist Puppet Interaction
- Keywords
- dental anxiety, behavior management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventriloquist Puppet InteractionBehavioural
children allocated to the Ventriloquist Puppet group were introduced to a Ventriloquist Puppet inside the clinic and were allowed to play, talk, and interact with the puppet for 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| control group: 25 child managed by basic behavior management tecniques | No intervention | this group managed normaly with the basic behavior managment techniques like tell , show , do and others |
| puppet therapy group: Children allocated to the Ventriloquist Puppet group | Active comparator | Children allocated to the Ventriloquist Puppet group were introduced to a Ventriloquist Puppet inside the clinic and were allowed to play , talk and interact with the puppet for five to 10 min Receives: Behavioral: Ventriloquist Puppet Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety
Change in Anxiety Score using MCDAS scale
Measured: From immediately before to immediately after the dental procedure
Heart rate
change in heart rate during the visit to investigate the anxiety effect using pulse oximeter
Measured: From immediately before to immediately after the dental procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start23 Jun 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdy Badreldin, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034833
- Sponsor's protocol ID
- 1200/384
- Acronym
- Puppets
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Ventriloquist Puppet for Reducing Dental Anxiety in Children
- ClinicalTrials.gov ID
- NCT07034833
- Acronym / sponsor ID
- Puppets / 1200/384
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, behavior management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 23 Jun 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 24 Jun 2025 (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.
thhe goal of this clinical trial is to assess the effect of ventriloquist puppets to reduce the strees accompined by the dental visit in cgilren . The main questions it aims to answer are:
- Does the ventriloquist puppet can reduce the stress accompanied by the dental visit for the children ?
- What medical problems do participants have when taking drug ABC? Researchers will compare ventriloquist puppet to a control group (conventional behavior management techniques ) to see if ventriloquist puppet can lower the anxiety or not.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group: 25 child managed by basic behavior management tecniques | No intervention | –this group managed normaly with the basic behavior managment techniques like tell , show , do and others |
| puppet therapy group: Children allocated to the Ventriloquist Puppet group | Active comparator | Behavioral: Ventriloquist Puppet InteractionChildren allocated to the Ventriloquist Puppet group were introduced to a Ventriloquist Puppet inside the clinic and were allowed to play , talk and interact with the puppet for five to 10 min |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- healthy children with no systemic diseases.
- children require dental intervention
Key exclusion criteria (2 listed)
- children with bad dental experience
- children require invasive surgical intervention
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 |
|---|---|---|
| Ventriloquist Puppet Interactionchildren allocated to the Ventriloquist Puppet group were introduced to a Ventriloquist Puppet inside the clinic and were allowed to play, talk, and interact with the puppet for 5-10 minutes. | Behavioural | puppet therapy group: Children allocated to the Ventriloquist Puppet group |
Primary outcome
Dental anxiety
Time frame: From immediately before to immediately after the dental procedure
Change in Anxiety Score using MCDAS scale
Heart rate
Time frame: From immediately before to immediately after the dental procedure
change in heart rate during the visit to investigate the anxiety effect using pulse oximeter
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 24 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ventriloquist Puppet Interaction in people with Dental Anxiety, run by Al-Azhar University.
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 2 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental anxiety (time frame: From immediately before to immediately after the dental procedure). The study lists 2 primary outcomes in all. 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 24 Jun 2025.