- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07632547
Video-Enhanced Tell-Show-Do for Managing Dental Anxiety in Children
Reinforcing the Tell-Show-Do Technique With a Simulated Real-mouth Video to Manage Dental Anxiety in Children During Dental Treatment (A Randomized Controlled Trial)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Dental fear and anxiety in children are associated with several visual stimuli, such as the shape of the dental handpiece or saliva ejector, as well as painful procedures like local anaesthesia, which may create a barrier to receiving dental treatment. Many studies have explored various behaviour management techniques to reduce anxiety during treatment; however, few have investigated the effect of using a video simulation of the real oral environment to familiarise children with treatment steps and reinforce the phrases commonly used by the dentist. This study was designed to reassure children by using a video that demonstrates carious lesions and dental instruments, including the mirror, saliva ejector, handpiece, and syringe, and shows how they work inside the mouth in a child-friendly manner.
This research is a randomised controlled clinical trial in which participants were assigned to two groups based on the behaviour management technique used. Anxiety was assessed using three integrated measures: a self-reported anxiety scale, an observer-rated behaviour scale, and physiological indicators including oxygen saturation and heart rate. All measures were recorded before, during, and after treatment to provide a comprehensive evaluation of the intervention's effect on children's anxiety levels.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Rana Soleman
- Numer telefonu: +963 934 966 599
- E-mail: drranasoliman66@gmail.com
Lokalizacje studiów
-
-
-
Damascus, Syria
- Rekrutacyjny
- Damascus University
-
Kontakt:
- Rana Soliman
- Numer telefonu: +963 934 966 599drranasoliman6
- E-mail: drranasoliman66@gmail.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Children aged 4-6 years, with or without previous dental experience.
- Children with a positive behavior rating according to the Frankl scale.
- Children with primary molars requiring conservative dental treatment.
Exclusion Criteria:
- Children with systemic or mental disorders.
- Children who received sedative or analgesic medications within the 3 hours prior to the dental visit.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Tell-Show-Do behavior management technique
Children in this group will receive restorative treatment with following the traditional TSD technique without any visual aids.
|
This group received treatment guided by the Tell-Show-Do (TSD) method.
Each step was explained through simple analogies-referring to local anesthesia as 'sleepy juice' and the rubber dam as a 'trap' for the 'tooth worm.'
After the explanation and instrument demonstration, restorative treatment was carried out.
The protocol excluded the use of any audiovisual aids.
All procedures involved conservative restoration of the mandibular primary molars
Inne nazwy:
Children in this group were managed using a video-assisted Tell-Show-Do (VATSD) approach incorporating real-oral simulation.
Each procedural step was preceded by a specific segment of a pre-recorded video tailored to the upcoming task.
The video featured a simulated intraoral environment where dental caries was personified by an animated 'tooth worm' to explain decay and its removal.
Consistent with conventional TSD, the video integrated child-friendly analogies: local anesthesia was introduced as 'sleepy juice'-depicting the 'tooth worm' falling asleep-and the rubber dam was shown as a barrier to prevent its escape.
These segments sequentially covered examination, anesthesia, rubber dam placement, and cavity preparation.
Each viewing was followed by a standardized verbal explanation before performing the clinical procedure.
All participants underwent conservative restorative treatment of the mandibular primary molars
Inne nazwy:
|
|
Eksperymentalny: Real-Oral Simulation Video-Assisted Tell-Show-Do Technique
Children in this group will receive restorative treatment with following the enhanced Tell-Show-Do technique with a video simulating the real oral environment
|
This group received treatment guided by the Tell-Show-Do (TSD) method.
Each step was explained through simple analogies-referring to local anesthesia as 'sleepy juice' and the rubber dam as a 'trap' for the 'tooth worm.'
After the explanation and instrument demonstration, restorative treatment was carried out.
The protocol excluded the use of any audiovisual aids.
All procedures involved conservative restoration of the mandibular primary molars
Inne nazwy:
Children in this group were managed using a video-assisted Tell-Show-Do (VATSD) approach incorporating real-oral simulation.
Each procedural step was preceded by a specific segment of a pre-recorded video tailored to the upcoming task.
The video featured a simulated intraoral environment where dental caries was personified by an animated 'tooth worm' to explain decay and its removal.
Consistent with conventional TSD, the video integrated child-friendly analogies: local anesthesia was introduced as 'sleepy juice'-depicting the 'tooth worm' falling asleep-and the rubber dam was shown as a barrier to prevent its escape.
These segments sequentially covered examination, anesthesia, rubber dam placement, and cavity preparation.
Each viewing was followed by a standardized verbal explanation before performing the clinical procedure.
All participants underwent conservative restorative treatment of the mandibular primary molars
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Heart Rate
Ramy czasowe: during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment.
|
Assessment tool: Pulse oximeter Measurement unit: Beats per minute (bpm) Assessment time points: Heart rate was assessed during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment. |
during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment.
|
|
Facial Image Scale (FIS)
Ramy czasowe: The Facial Image Scale was assessed during a single dental treatment visit at baseline (first visit before intervention) and during dental treatment.
|
Assessment tool: Facial Image Scale questionnaire Measurement unit: Ordinal score (1-5) Assessment time points: Facial Image Scale was assessed during a single dental treatment visit at baseline and during treatment. |
The Facial Image Scale was assessed during a single dental treatment visit at baseline (first visit before intervention) and during dental treatment.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Oxygen Saturation (SpO₂)
Ramy czasowe: Baseline; after behavior management; during injection; before rubber dam placement; during rubber dam placement; before handpiece use; during treatment during a single dental treatment visit.
|
Assessment tool: Pulse oximeter Measurement unit: Percentage (%) Assessment time points: Oxygen saturation was measured using a pulse oximeter and recorded during a single dental treatment visit at baseline, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during dental treatment. |
Baseline; after behavior management; during injection; before rubber dam placement; during rubber dam placement; before handpiece use; during treatment during a single dental treatment visit.
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Chaza Kouchaji, Damascus University
Publikacje i pomocne linki
Publikacje ogólne
- Liu Y, Gu Z, Wang Y, Wu Q, Chen V, Xu X, Zhou X. Effect of audiovisual distraction on the management of dental anxiety in children: A systematic review. Int J Paediatr Dent. 2019 Jan;29(1):14-21. doi: 10.1111/ipd.12430. Epub 2018 Oct 26.
- Abbasi H, Saqib M, Jouhar R, Lal A, Ahmed N, Ahmed MA, Alam MK. The Efficacy of Little Lovely Dentist, Dental Song, and Tell-Show-Do Techniques in Alleviating Dental Anxiety in Paediatric Patients: A Clinical Trial. Biomed Res Int. 2021 May 23;2021:1119710. doi: 10.1155/2021/1119710. eCollection 2021.
- Khandelwal D, Kalra N, Tyagi R, Khatri A, Gupta K. Control of Anxiety in Pediatric Patients using "Tell Show Do" Method and Audiovisual Distraction. J Contemp Dent Pract. 2018 Sep 1;19(9):1058-1064.
- Seligman LD, Hovey JD, Chacon K, Ollendick TH. Dental anxiety: An understudied problem in youth. Clin Psychol Rev. 2017 Jul;55:25-40. doi: 10.1016/j.cpr.2017.04.004. Epub 2017 Apr 19.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- UDDS-Pedo-03-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Behavioral Treatment
-
Education University of Hong KongThe University of Hong Kong; Columbia University; The Hong Kong Polytechnic University i inni współpracownicyJeszcze nie rekrutacja
-
Candela CorporationJeszcze nie rekrutacjaChoroby naczyniowe | Trądzik różowaty | Plama z wina porto
-
Brigham and Women's HospitalThe Thompson Family Foundation IncAktywny, nie rekrutującyDepresja | Lęk | Psychoza | Behawioralne i psychiatryczne objawy demencjiStany Zjednoczone
-
Abilion Medical Systems ABInsamlingsstiftelsen för främjande av forskning avseende INMEST; AureviaRekrutacyjny
-
Sarah MorrowLawson Health Research InstituteZakończony
-
Elena Pérez Expósito, MDJeszcze nie rekrutacja
-
Stanford UniversityNational Institute on Drug Abuse (NIDA)Jeszcze nie rekrutacjaUżywanie konopi indyjskichStany Zjednoczone
-
i+Med S.Coop.Dr. Goya Análisis, SL.Zakończony
-
Church & Dwight Company, Inc.TherametricsZakończonyPróchnica zębówStany Zjednoczone
-
Riphah International UniversityRekrutacyjnyUpośledzenie funkcji poznawczych | Zaburzenia poznawcze w starszym wieku | Mobilność funkcjonalna | Zmiany równowagiPakistan