- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07626008
Tell-Show-Do for Reducing Dental Anxiety During Local Anesthesia
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.
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Istanbul
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Istanbul, Istanbul, Turecko (Türkiye)
- Bezmialem Vakif University Faculty of Dentistry Department of PEdiatric Dentistry
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Children requiring dental treatment under buccal infiltration local anesthesia
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Early Tell-Show-Do Dental Injector Demonstration Sequence
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.
|
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.
|
|
Aktivní komparátor: Delayed Tell-Show-Do Dental Injector Demonstration Sequence
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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
State Dental Anxiety Assessed by the Facial Image Scale
Časové okno: 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.
|
Immediately after local anesthesia administration at each injection-related visit, over the 3-month study period.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Child Cooperation Assessed by the Modified Frankl Behavior Scale
Časové okno: During local anesthesia administration at each injection-related visit, over the 3-month study period.
|
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.
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During local anesthesia administration at each injection-related visit, over the 3-month study period.
|
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Pain-Related Response Assessed by the Sound-Eye-Motor Scale
Časové okno: Before, during, and after local anesthesia administration at each injection-related visit, over the 3-month study period.
|
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.
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Before, during, and after local anesthesia administration at each injection-related visit, over the 3-month study period.
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Parent-Reported Child Dental Fear Assessed by the Children's Fear Survey Schedule-Dental Subscale
Časové okno: At the adaptation appointment before the injection-related visits.
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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.
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At the adaptation appointment before the injection-related visits.
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Trait Dental Anxiety Assessed by the Human Figure Drawing Scale
Časové okno: At the adaptation appointment and at the end of each injection-related visit, over the 3-month study period.
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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.
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At the adaptation appointment and at the end of each injection-related visit, over the 3-month study period.
|
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Child Behavior Assessed by the Frankl Behavior Rating Scale
Časové okno: During the adaptation appointment before the injection-related visits.
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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.
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During the adaptation appointment before the injection-related visits.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Mustafa Sarp Kaya, DDS, PhD, Bezmialem Vakif University Department of Pediatric Dentistry
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2011-KAEK-42
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