- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07736170
Effectiveness of Puppet Modeling During Dental Emergency Visits on Dental Anxiety and Behavior of Children in a Subsequent Visit
Effect of Puppet-Aided Tell-Show-Do During Dental Emergency Visit on Dental Anxiety and Behavior of Children in a Subsequent Visit: A Randomized Clinical Trial
The goal of this clinical trial is to learn if using a puppet in dental visits for children is an effective behavior guidance tool. The main questions it aims to answer are:
- Does using a puppet to explain dental procedures to children during emergency dental visits lower their anxiety in a subsequent dental visit?
- Does using a puppet to explain dental procedures to children during emergency dental visits improve their behavior in a subsequent dental visit?
Researchers compared the effect of using a puppet to the traditional tell-show-do behavior guidance technique to see if the puppet is more effective in lowering their anxiety and improving their behavior.
Participants were randomly allocated into two groups:
- Group I: Children who received puppet play therapy in the emergency dental visit and in the subsequent dental visit.
- Group II: Children who received only the traditional tell-show-do behavior guidance technique in the emergency dental visit and in the subsequent dental visit.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Jeddah, Arabia Saudyjska
- King Abdulaziz University Dental Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- healthy (including healthy children presenting with a localized dental abscess and no systemic involvement),
- Arabic-speaking
- and required emergency dental treatment under local anesthesia
Exclusion Criteria:
- ASA II or higher according to the American Society of Anesthesiologists Physical Status Classification,
- or if they required advanced behavior guidance, such as protective stabilization, during the emergency visit.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Puppet-aided TSD
Children who received puppet-aided tell-show-do as a behavior guidance technique in the emergency dental visit.
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The investigator used the puppet to interact with the participants and explain the treatment in simple language before starting the dental procedure.
Inne nazwy:
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Aktywny komparator: TSD
Children who received traditional tell-show-do as a behavior guidance technique in the emergency dental visit.
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Tell: The dentist explained what is about to happen using simple, age-appropriate language. Show: The dentist demonstrated the tool outside of the patient's mouth. Do: The dentist performed the procedure in the patient's mouth exactly as described. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Subjective Dental Anxiety as Assessed by Venham Picture Test (VPT) for Children Aged 3-5 Years
Ramy czasowe: 2 weeks after the intervention
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The scale consists of eight pairs of images, each showing a child in both anxious and calm states.
Children are asked to select one image from each pair that best represents how they feel.
Each anxious image chosen is scored as one, while calm selections are scored as zero.
The total dental anxiety score, which ranges from zero to eight, is calculated by summing the individual scores, with higher totals indicating greater anxiety.
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2 weeks after the intervention
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Subjective Dental Anxiety as Assessed by Abeer Children Dental Anxiety Scale (ACDAS) for Children Aged 6-9 Years
Ramy czasowe: 2 weeks after the intervention
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The scale is divided into three sections.
Part A includes 13 self-reported items presented in a logical sequence, in which children indicate their feelings toward different dental situations using three facial expressions: happy/relaxed (score = 1), neutral/ "OK" (score = 2), and scared/anxious (score = 3).
The total score ranges from 13 to 39; scores ≥26 indicate significant dental anxiety.
Part B consists of three yes/no questions exploring the child's cognitive concerns, such as shyness about their teeth or dentist, and fear of losing control during treatment.
Part C gathers additional information from both the parent/guardian and the dentist: parents report on the child's previous dental experiences and anticipated behavior, while the dentist records the child's behavior after treatment.
By combining self-reported, parental, and clinical perspectives, ACDAS provides a comprehensive assessment of dental anxiety in children
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2 weeks after the intervention
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Objective Dental Anxiety as Assessed by the Venham Anxiety Rating Scale (VARS)
Ramy czasowe: 2 weeks after the intervention
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The VARS is constructed of six behaviorally defined categories that range from zero to five, with higher scores indicating higher levels of dental anxiety.
The score gradually increases from relaxed (Score 0), to the child is totally out of control (Score 5).
The target population for this scale is children aged 3-12 years.
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2 weeks after the intervention
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Behavior as Assessed by the Behavior Profile Rating Scale (BPRS)
Ramy czasowe: 2 weeks after the intervention
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An independent observer, other than the operating dentist, is required to systematically record the occurrence of 27 distinct behavioral aspects over a series of 3-minute intervals. Four of these behaviors assess the child's reaction to his separation from a parent. The remaining 23 aspects assess the child's behavior in the dental office. Each behavior is assigned a weighted score that reflects its level of disruptiveness. The total score is calculated by multiplying the frequency of each behavior during the 3-minute periods by its weight, then summing the results across all categories and dividing by the number of intervals. In this study, the BPRS was adapted to be applied once per quadrant during oral prophylaxis, rather than at fixed 3-minute intervals, because the procedure was short and, in some cases, did not extend to three minutes. |
2 weeks after the intervention
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Behavior as Assessed by the Frankl Behavior Rating Scale (FBRS)
Ramy czasowe: immediately after the procedure
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This scale classifies patient behavior into four specific categories.:Definitely
Negative (Rating 1): The child completely refuses treatment, cries forcefully, shows extreme fear, or displays overt negativism.Negative (Rating 2): The child is reluctant to accept treatment and uncooperative, but there is no extreme negativism (e.g., no forceful crying or treatment refusal).Positive (Rating 3): The child accepts treatment and is generally willing to comply with the dentist's directions, though they may be a bit cautious or reserved.Definitely Positive (Rating 4): The child has excellent rapport with the dentist, shows genuine interest in the procedure, laughs, and enjoys the visit.
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immediately after the procedure
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Athanassiadou E, Giannakopoulos G, Kolaitis G, Tsiantis J, Christogiorgos S. Preparing the child facing surgery: The use of play therapy. Psychoanalytic social work. 2012;19(1-2):91-100.
- Khogeer LN, Sabbagh HJ, Felemban OM, Farsi NM. Puppet play therapy in emergency pediatric dental clinic. A randomized clinical trial. BMC Pediatr. 2025 Jul 2;25(1):503. doi: 10.1186/s12887-025-05849-5.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
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
Słowa kluczowe
Inne numery identyfikacyjne badania
- 119-06-23
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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