- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07739381
Effects of Virtual Reality and Tablet Distraction During IV Cannulation in Children
The Effect of Watching an Entertaining Video With Virtual Reality Glasses and a Tablet on Pain, Anxiety, and Fear During Intravenous Cannulation in Children in the Emergency Department: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study was designed as a randomized controlled trial involving children aged 7 to 12 years who required intravenous cannulation in a pediatric emergency department. Eligible participants were randomly assigned in a 1:1:1 ratio to a virtual reality group, a tablet group, or a control group.
Children assigned to the virtual reality group watched an entertaining audiovisual video using a virtual reality headset during intravenous cannulation. Children assigned to the tablet group watched the same video on a tablet during the procedure. Children in the control group underwent intravenous cannulation according to the routine clinical practice of the emergency department without an audiovisual distraction intervention.
Anxiety and fear were assessed immediately before intravenous cannulation and again five minutes after the procedure. Pain was assessed immediately after intravenous cannulation. The primary purpose of the study was to determine whether virtual reality and tablet-based distraction reduced procedure-related pain, anxiety, and fear and to compare the effectiveness of these interventions.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Kütahya
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Kütahya, Kütahya, Turquie (Türkiye), 4300
- Kütahya Evliya Çelebi Training and Research Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- It was that the child belonged to the 7-12 age group and was fully conscious.
Exclusion Criteria:
- Children with hearing, cognitive, or visual impairments; children unaccompanied by a parent; children with whom communication cannot be established; and children with critical health issues and/or conditions requiring immediate intervention.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Virtual Reality Group
Children watched an age-appropriate entertaining video using a virtual reality headset during intravenous cannulation.
|
Children in the virtual reality group received virtual reality-based distraction during intravenous cannulation.
A virtual reality headset was used to divert the child's attention from the procedure.
|
|
Expérimental: tablet Group
Children watched the same age-appropriate entertaining video on a tablet during intravenous cannulation.
|
Children in the tablet group watched an age-appropriate cartoon on a tablet during intravenous cannulation to divert their attention from the procedure.
|
|
Aucune intervention: control group
Children underwent intravenous cannulation according to routine clinical practice without any audiovisual distraction intervention.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain During Intravenous Cannulation
Délai: Immediately after intravenous cannulation
|
Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale.
The scale consists of six facial expressions representing increasing levels of pain.
Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Pain was assessed immediately after intravenous cannulation.
|
Immediately after intravenous cannulation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiety Before and After Intravenous Cannulation
Délai: Immediately before and immediately after intravenous cannulation
|
Anxety was assesed using the scale .Higher scores indicate greater anxiety.
|
Immediately before and immediately after intravenous cannulation
|
Collaborateurs et enquêteurs
Parrainer
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021/284
Informations sur les médicaments et les dispositifs, documents d'étude
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