- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07715539
The Effect of a Preparation Video Using " Cartoon Animated Video Modeling" on Preoperative Anxiety Among Pre-School Children During The First Dental Visit: A Randomized Clinical Trial
The primary aim of this study is to evaluate the efficacy of cartoon animated video-modeling in reducing preoperative anxiety among pre-school children during the first dental visit. Secondary aims include assessing the effect on parental anxiety and overall parental satisfaction.
Participants will be randomly assigned to either the intervention group, which will watch an animated video modeling the dental visit, or the control group, which will receive standard pre-visit information. Anxiety levels will be measured at five different time points.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background: The first dental visit can be a very challenging experience for children, and anxiety at this stage may influence behaviour during treatment and future dental attendance.
Non-pharmacological interventions such as animated video modelling may help reduce preoperative anxiety.
Aim: The primary aim of this study was to evaluate the efficacy of a cartoon animated video-modelling intervention in reducing preoperative anxiety among preschool children during their first dental visit. The secondary aim was to assess the effect of the intervention on parental anxiety.
Methods: This single-blinded randomised controlled trial was conducted at the Postgraduate Paediatric Dental Clinic at Jordan University of Science and Technology.
Ninety-four healthy children aged 4-6 years with no previous dental experience were randomly allocated to a video-modelling group or a control group (n = 47 per group).
Expected results: The study predicts animated videos will lower children's preoperative anxiety and improve the overall dental experience for both parent and child. This could lead to video modeling being used in pediatric dentistry, especially for low-income families, to reduce anxiety and improve patient outcomes.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Irbid, Jordan, 22110
- Jordan University of Science and Technology
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
Medically healthy children classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Age 4-6 years.
- Children presenting to the JUST postgraduate paediatric dental clinic with no previous dental visits.
Exclusion Criteria:
Children with systemic medical conditions or with mental, cognitive, or intellectual disabilities.
- Children with visual or hearing impairments.
- Participants unwilling to complete subjective anxiety assessment scales due to elevated anxiety levels.
- Children whose parents are unable to read or write.
- Participants without access to internet services.
- Children presenting with severe active dental pain and/or facial abscess, as these conditions may influence state anxiety.
- Children with previous dental experience.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: video-modelling group
Children allocated to the intervention group received a cartoon-animated video designed to familiarise them with their first dental visit.
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The cartoon-animated video followed a child character's journey from home to arrival at the clinic, introduction to the dentist, and progression through the dental visit.
The video showed the child character progressing through the main stages of a routine dental visit, including seating in the dental chair, intra-oral examination, radiographic assessment in the radiography room, and preventive procedures.
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Aucune intervention: Control group
Children in the control group received routine care upon arrival at the clinic, which consisted of a verbal explanation of the planned procedures while in the waiting area.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in children's anxiety scores measured using the Modified Yale Preoperative Anxiety Scale
Délai: Upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5)
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Children's anxiety was assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS), an observational behavioural scale evaluating anxiety-related behaviours across five domains: activity, vocalization, emotional expressivity, state of apparent arousal, and use of parents.
Scores range from 23.33 to 100, with higher scores indicating greater anxiety.
Assessments were conducted by a blinded research assistant upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5).
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Upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5)
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Change in children's anxiety scores measured using the Visual Facial Anxiety Scale (VFAS)
Délai: Baseline (day prior to dental visit) through 10-15 minutes post-procedure
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Children's self-reported anxiety was assessed using the Visual Facial Anxiety Scale (VFAS), a validated scale consisting of facial expressions representing increasing levels of anxiety.
Children selected the face that best reflects their anxiety level at each time point.
Assessments were conducted at baseline (T1), upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the procedure (T4), and 10-15 minutes after completion of the procedure (T5).
Scores range from 0 to 5, with higher scores indicating greater anxiety.
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Baseline (day prior to dental visit) through 10-15 minutes post-procedure
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change in parental anxiety scores measured using the State-Trait Anxiety Inventory State Subscale
Délai: Day before the dental appointment (T1) and 10-15 minutes after completion of the child's dental procedure (T5)
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Parental anxiety was assessed using the State subscale of the State-Trait Anxiety Inventory (STAI-State), which measures situational anxiety at the time of assessment.
Scores range from 20 to 80, with higher scores indicating greater anxiety.
Parents completed the questionnaire on the day before the dental appointment (T1) and again 10-15 minutes after completion of the child's dental procedure (T5).
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Day before the dental appointment (T1) and 10-15 minutes after completion of the child's dental procedure (T5)
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Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Mawia Bataineh, Jordan University of Science and Technology
Publications et liens utiles
Publications générales
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 20240602
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Données/documents d'étude
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Protocole d'étude
Commentaires d'informations: study protocol not published
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Formulaire de consentement éclairé
Commentaires d'informations: informed consent not published
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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