School Age ChildrenNCT07626008
Tell-Show-Do for Reducing Dental Anxiety During Local Anesthesia
A study testing Early Tell-Show-Do Dental Injector Demonstration Sequence and Delayed Tell-Show-Do Dental Injector Demonstration Sequence in people with School Age Children and Dental Fear, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Dental anxiety is common in children and may increase during local anesthesia administration. Dental injection anxiety is one of the most frequently reported causes of dental anxiety in pediatric dental patients. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- School Age Children, Dental Fear
- What is being tested?
- Early Tell-Show-Do Dental Injector Demonstration Sequence and Delayed Tell-Show-Do Dental Injector Demonstration Sequence
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children requiring dental treatment under buccal infiltration local anesthesia
Who cannot join
- Children whose parents/legal guardians refuse to sign the informed consent form
- Children whose parents/legal guardians do not consent to the demonstration of the dental injector
- Children requiring emergency treatment
- Children with special healthcare needs
- Children with a history of previous dental treatment performed under local anesthesia via injection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry
Istanbul, Istanbul
About this study
Official title: Effect of the Tell-Show-Do Technique on Dental Anxiety During Local Anesthesia Administration in School-Aged Children
Dental anxiety is common in children and may increase during local anesthesia administration. Dental injection anxiety is one of the most frequently reported causes of dental anxiety in pediatric dental patients. Communication-based behavior guidance techniques are commonly used to reduce anxiety during dental procedures. Among these techniques, tell-show-do is widely used in pediatric dentistry and is generally accepted by parents.
This completed interventional study evaluated the effect of introducing the syringe and related injection equipment using the tell-show-do technique on dental anxiety during local anesthesia administration in school-aged children. Children aged 5 to 7 years who required dental treatment under buccal infiltration local anesthesia and had no previous dental treatment experience involving injection were enrolled after parental consent was obtained.
Read more
The study used a controlled within-subject design. Each child attended an adaptation appointment followed by two dental treatment appointments involving local anesthesia. The syringe and related equipment were introduced using the tell-show-do technique at one local anesthesia appointment, whereas the injection equipment was kept out of the child's field of vision at the other local anesthesia appointment. The order of exposure to the tell-show-do intervention differed between sequence groups.
Dental anxiety, behavior, and pain-related responses were assessed using validated scales, including the Facial Image Scale, Human Figure Drawing scale, Frankl Behavior Scale, Modified Frankl Behavior Scale, and Sound-Eye-Motor scale. Parent-reported child dental fear and parental dental anxiety were also recorded.
Read the detailed description
This completed interventional study was designed to evaluate the effect of the tell-show-do behavior guidance technique on dental anxiety during local anesthesia administration in school-aged children. The behavioral intervention consisted of introducing the syringe and related injection equipment to the child before local anesthesia administration using the tell-show-do technique.
Eligible participants were children aged 5 to 7 years who presented to the faculty pediatric dentistry clinic and required dental treatment involving buccal infiltration local anesthesia. Children were included if no previous dental treatment involving injection had been performed, no urgent dental treatment was required, and no special health care needs were present. Participation was based on parental informed consent.
The study followed a controlled within-subject interventional design with two exposure conditions. Each participant attended an initial adaptation appointment followed by two treatment appointments involving local anesthesia. During the adaptation appointment, a preventive dental procedure not requiring injection, such as fissure sealant application, fluoride application, or prophylaxis, was performed to familiarize the child with the dental setting.
At the end of the adaptation appointment, baseline trait dental anxiety was assessed using the Human Figure Drawing scale after the child was asked to draw a child receiving dental treatment in a clinic. Parent-reported child dental fear was assessed using the Children's Fear Survey Schedule-Dental Subscale. Parental dental anxiety was assessed using the Modified Dental Anxiety Scale and the Dental Anxiety Inventory Short Form. The child's behavior during dental treatment was evaluated using the Frankl Behavior Scale.
Participants were assigned to one of two intervention sequences. In one sequence, the tell-show-do intervention was applied during the second appointment, and the hidden-instrument condition was applied during the third appointment. In the other sequence, the hidden-instrument condition was applied during the second appointment, and the tell-show-do intervention was applied during the third appointment. In this design, each child served as an internal control.
During the tell-show-do condition, the syringe and related injection equipment were introduced before local anesthesia administration. The syringe and needle were assembled in front of the child, and the syringe was described in child-appropriate language, such as a hollow tube. Local anesthesia was then administered after the introduction of the equipment.
During the hidden-instrument condition, the syringe and related equipment were kept outside the child's field of vision before and during local anesthesia administration. The injection was performed with the child's eyes closed, and the equipment was not introduced before the procedure.
State dental anxiety after local anesthesia administration was assessed using the Facial Image Scale, which includes five facial images representing different emotional states. At the end of the second and third appointments, trait dental anxiety was reassessed using the Human Figure Drawing scale. Child behavior during local anesthesia administration was evaluated using the Modified Frankl Behavior Scale. Pain-related responses before, during, and after injection were assessed from video recordings using the Sound-Eye-Motor scale by an independent rater.
Statistical analysis included Spearman correlation analysis, independent samples t-test, and Mann-Whitney U test, as appropriate. Statistical significance was set at p < 0.05.
- Conditions
- School Age Children, Dental Fear
- Being tested
- Early Tell-Show-Do Dental Injector Demonstration Sequence, Delayed Tell-Show-Do Dental Injector Demonstration Sequence
- Keywords
- Tell-show-do, dental anxiety, local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Tell-Show-Do Dental Injector Demonstration SequenceBehavioural
This behavioral intervention sequence consisted of introducing the dental injector and related equipment using the tell-show-do technique before local anesthesia administration at the first injection-related visit. At the subsequent injection-related visit, the dental injector and related equipment were kept outside the child's field of vision before and during local anesthesia administration.
Delayed Tell-Show-Do Dental Injector Demonstration SequenceBehavioural
This behavioral intervention sequence consisted of local anesthesia administration with the dental injector and related equipment kept outside the child's field of vision at the first injection-related visit. At the subsequent injection-related visit, the dental injector and related equipment were introduced using the tell-show-do technique before local anesthesia administration.
| Study group | Role | What they receive |
|---|---|---|
| Early Tell-Show-Do Dental Injector Demonstration Sequence | Experimental | Participants in this arm received the tell-show-do dental injector demonstration at the first injection-related visit. At the subsequent injection-related visit, the dental injector and related equipment were kept outside the child's field of vision before and during local anesthesia administration. Receives: Behavioral: Early Tell-Show-Do Dental Injector Demonstration Sequence |
| Delayed Tell-Show-Do Dental Injector Demonstration Sequence | Active comparator | Participants in this arm first received local anesthesia with the dental injector and related equipment kept outside the child's field of vision. At the subsequent injection-related visit, the dental injector and related equipment were introduced using the tell-show-do technique before local anesthesia administration. Receives: Behavioral: Delayed Tell-Show-Do Dental Injector Demonstration Sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Dental Anxiety Assessed by the Facial Image Scale
State dental anxiety after local anesthesia administration was assessed using the Facial Image Scale. The Facial Image Scale is a self-report scale consisting of five faces ranging from very happy to very unhappy. Scores range from 1 to 5, with higher scores indicating greater state dental anxiety.
Measured: Immediately after local anesthesia administration at each injection-related visit, over the 3-month study period.
Secondary outcomes (5)
Child Cooperation Assessed by the Modified Frankl Behavior Scale
Child cooperation during local anesthesia administration was assessed using the Modified Frankl Behavior Scale. Scores range from 1 to 4, with higher scores indicating more positive behavior and better cooperation.
Measured: During local anesthesia administration at each injection-related visit, over the 3-month study period.
Pain-Related Response Assessed by the Sound-Eye-Motor Scale
Pain-related behavioral response before, during, and after local anesthesia administration was assessed from video recordings using the Sound-Eye-Motor scale. The Sound-Eye-Motor scale evaluates sound, eye, and motor responses. Total scores range from 3 to 12, with higher scores indicating greater pain-related behavior or discomfort.
Measured: Before, during, and after local anesthesia administration at each injection-related visit, over the 3-month study period.
Parent-Reported Child Dental Fear Assessed by the Children's Fear Survey Schedule-Dental Subscale
Parent-reported child dental fear was assessed using the Children's Fear Survey Schedule-Dental Subscale. The scale consists of 15 items scored on a 5-point Likert scale. Total scores range from 15 to 75, with higher scores indicating greater dental fear.
Measured: At the adaptation appointment before the injection-related visits.
Trait Dental Anxiety Assessed by the Human Figure Drawing Scale
Trait dental anxiety was assessed using the Human Figure Drawing scale. The scale was scored according to the study scoring system, with total scores ranging from 15 to 290. Higher scores indicate greater trait dental anxiety.
Measured: At the adaptation appointment and at the end of each injection-related visit, over the 3-month study period.
Child Behavior Assessed by the Frankl Behavior Rating Scale
Child behavior during the adaptation appointment was assessed using the Frankl Behavior Rating Scale. Scores range from 1 to 4, with higher scores indicating more positive behavior and better cooperation.
Measured: During the adaptation appointment before the injection-related visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Sep 2022
- Primary completion28 Nov 2022
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School Age ChildrenStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study used a two-sequence crossover design. Participants were assigned to either an early tell-show-do dental injector demonstration sequence or a delayed tell-show-do dental injector demonstration sequence. Each participant underwent two injection-related visits: one visit with tell-show-do dental injector demonstration before local anesthesia administration and one visit with the dental injector kept outside the child's field of vision. The order of these two conditions differed between the study arms, allowing each participant to serve as an internal control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Sarp Kaya, Bezmialem Vakif University
- Investigators
- Mustafa Sarp Kaya, DDS, PhD, Study director, Bezmialem Vakif University Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626008
- Sponsor's protocol ID
- 2011-KAEK-42
- Status last verified
- Mar 2026
- First submitted
- 23 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Tell-Show-Do Technique on Dental Anxiety During Local Anesthesia Administration in School-Aged Children
- ClinicalTrials.gov ID
- NCT07626008
- Acronym / sponsor ID
- 2011-KAEK-42
- Conditions
- School Age Children, Dental Fear
- Keywords
- Tell-show-do, dental anxiety, local anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 4 Jun 2026 (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.
Dental anxiety is common in children and may increase during local anesthesia administration. Dental injection anxiety is one of the most frequently reported causes of dental anxiety in pediatric dental patients. Communication-based behavior guidance techniques are commonly used to reduce anxiety during dental procedures. Among these techniques, tell-show-do is widely used in pediatric dentistry and is generally accepted by parents.
This completed interventional study evaluated the effect of introducing the syringe and related injection equipment using the tell-show-do technique on dental anxiety during local anesthesia administration in school-aged children. Children aged 5 to 7 years who required dental treatment under buccal infiltration local anesthesia and had no previous dental treatment experience involving injection were enrolled after parental consent was obtained.
The study used a controlled within-subject design. Each child attended an adaptation appointment followed by two dental treatment appointments involving local anesthesia. The syringe and related equipment were introduced using the tell-show-do technique at one local anesthesia appointment, whereas the injection equipment was kept out of the child's field of vision at the other local anesthesia appointment. The order of exposure to the tell-show-do intervention differed between sequence groups.
Dental anxiety, behavior, and pain-related responses were assessed using validated scales, including the Facial Image Scale, Human Figure Drawing scale, Frankl Behavior Scale, Modified Frankl Behavior Scale, and Sound-Eye-Motor scale. Parent-reported child dental fear and parental dental anxiety were also recorded.
Detailed description
This completed interventional study was designed to evaluate the effect of the tell-show-do behavior guidance technique on dental anxiety during local anesthesia administration in school-aged children. The behavioral intervention consisted of introducing the syringe and related injection equipment to the child before local anesthesia administration using the tell-show-do technique.
Eligible participants were children aged 5 to 7 years who presented to the faculty pediatric dentistry clinic and required dental treatment involving buccal infiltration local anesthesia. Children were included if no previous dental treatment involving injection had been performed, no urgent dental treatment was required, and no special health care needs were present. Participation was based on parental informed consent.
The study followed a controlled within-subject interventional design with two exposure conditions. Each participant attended an initial adaptation appointment followed by two treatment appointments involving local anesthesia. During the adaptation appointment, a preventive dental procedure not requiring injection, such as fissure sealant application, fluoride application, or prophylaxis, was performed to familiarize the child with the dental setting.
At the end of the adaptation appointment, baseline trait dental anxiety was assessed using the Human Figure Drawing scale after the child was asked to draw a child receiving dental treatment in a clinic. Parent-reported child dental fear was assessed using the Children's Fear Survey Schedule-Dental Subscale. Parental dental anxiety was assessed using the Modified Dental Anxiety Scale and the Dental Anxiety Inventory Short Form. The child's behavior during dental treatment was evaluated using the Frankl Behavior Scale.
Participants were assigned to one of two intervention sequences. In one sequence, the tell-show-do intervention was applied during the second appointment, and the hidden-instrument condition was applied during the third appointment. In the other sequence, the hidden-instrument condition was applied during the second appointment, and the tell-show-do intervention was applied during the third appointment. In this design, each child served as an internal control.
During the tell-show-do condition, the syringe and related injection equipment were introduced before local anesthesia administration. The syringe and needle were assembled in front of the child, and the syringe was described in child-appropriate language, such as a hollow tube. Local anesthesia was then administered after the introduction of the equipment.
During the hidden-instrument condition, the syringe and related equipment were kept outside the child's field of vision before and during local anesthesia administration. The injection was performed with the child's eyes closed, and the equipment was not introduced before the procedure.
State dental anxiety after local anesthesia administration was assessed using the Facial Image Scale, which includes five facial images representing different emotional states. At the end of the second and third appointments, trait dental anxiety was reassessed using the Human Figure Drawing scale. Child behavior during local anesthesia administration was evaluated using the Modified Frankl Behavior Scale. Pain-related responses before, during, and after injection were assessed from video recordings using the Sound-Eye-Motor scale by an independent rater.
Statistical analysis included Spearman correlation analysis, independent samples t-test, and Mann-Whitney U test, as appropriate. Statistical significance was set at p < 0.05.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study used a two-sequence crossover design. Participants were assigned to either an early tell-show-do dental injector demonstration sequence or a delayed tell-show-do dental injector demonstration sequence. Each participant underwent two injection-related visits: one visit with tell-show-do dental injector demonstration before local anesthesia administration and one visit with the dental injector kept outside the child's field of vision. The order of these two conditions differed between the study arms, allowing each participant to serve as an internal control.
| Arm | Type | Receives |
|---|---|---|
| Early Tell-Show-Do Dental Injector Demonstration Sequence | Experimental | Behavioral: Early Tell-Show-Do Dental Injector Demonstration SequenceParticipants in this arm received the tell-show-do dental injector demonstration at the first injection-related visit. At the subsequent injection-related visit, the dental injector and related equipment were kept outside the child's field of vision before and during local anesthesia administration. |
| Delayed Tell-Show-Do Dental Injector Demonstration Sequence | Active comparator | Behavioral: Delayed Tell-Show-Do Dental Injector Demonstration SequenceParticipants in this arm first received local anesthesia with the dental injector and related equipment kept outside the child's field of vision. At the subsequent injection-related visit, the dental injector and related equipment were introduced using the tell-show-do technique before local anesthesia administration. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children requiring dental treatment under buccal infiltration local anesthesia
Key exclusion criteria (5 listed)
- Children whose parents/legal guardians refuse to sign the informed consent form
- Children whose parents/legal guardians do not consent to the demonstration of the dental injector
- Children requiring emergency treatment
- Children with special healthcare needs
- Children with a history of previous dental treatment performed under local anesthesia via injection
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 |
|---|---|---|
| Early Tell-Show-Do Dental Injector Demonstration SequenceThis behavioral intervention sequence consisted of introducing the dental injector and related equipment using the tell-show-do technique before local anesthesia administration at the first injection-related visit. At the subsequent injection-related visit, the dental injector and related equipment were kept outside the child's field of vision before and during local anesthesia administration. | Behavioural | Early Tell-Show-Do Dental Injector Demonstration Sequence |
| Delayed Tell-Show-Do Dental Injector Demonstration SequenceThis behavioral intervention sequence consisted of local anesthesia administration with the dental injector and related equipment kept outside the child's field of vision at the first injection-related visit. At the subsequent injection-related visit, the dental injector and related equipment were introduced using the tell-show-do technique before local anesthesia administration. | Behavioural | Delayed Tell-Show-Do Dental Injector Demonstration Sequence |
Primary outcome
State Dental Anxiety Assessed by the Facial Image Scale
Time frame: Immediately after local anesthesia administration at each injection-related visit, over the 3-month study period.
State dental anxiety after local anesthesia administration was assessed using the Facial Image Scale. The Facial Image Scale is a self-report scale consisting of five faces ranging from very happy to very unhappy. Scores range from 1 to 5, with higher scores indicating greater state dental anxiety.
5 secondary outcomes
Child Cooperation Assessed by the Modified Frankl Behavior Scale
Time frame: During local anesthesia administration at each injection-related visit, over the 3-month study period.
Pain-Related Response Assessed by the Sound-Eye-Motor Scale
Time frame: Before, during, and after local anesthesia administration at each injection-related visit, over the 3-month study period.
Parent-Reported Child Dental Fear Assessed by the Children's Fear Survey Schedule-Dental Subscale
Time frame: At the adaptation appointment before the injection-related visits.
Trait Dental Anxiety Assessed by the Human Figure Drawing Scale
Time frame: At the adaptation appointment and at the end of each injection-related visit, over the 3-month study period.
Child Behavior Assessed by the Frankl Behavior Rating Scale
Time frame: During the adaptation appointment before the injection-related visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- 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. This study is not recruiting at the moment.
Mustafa Sarp Kaya, DDS, PhD study director
Bezmialem Vakif University Department of Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Tell-Show-Do Dental Injector Demonstration Sequence and Delayed Tell-Show-Do Dental Injector Demonstration Sequence in people with School Age Children and Dental Fear, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 4 Jun 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
State Dental Anxiety Assessed by the Facial Image Scale (time frame: Immediately after local anesthesia administration at each injection-related visit, over the 3-month study period.). 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 4 Jun 2026.