- ICH GCP
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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Kütahya
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Kütahya, Kütahya, Turkije (Türkiye), 4300
- Kütahya Evliya Çelebi Training and Research Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Virtual Reality Group
Children watched an age-appropriate entertaining video using a virtual reality headset during intravenous cannulation.
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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.
|
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Experimenteel: tablet Group
Children watched the same age-appropriate entertaining video on a tablet during intravenous cannulation.
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Children in the tablet group watched an age-appropriate cartoon on a tablet during intravenous cannulation to divert their attention from the procedure.
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Geen tussenkomst: control group
Children underwent intravenous cannulation according to routine clinical practice without any audiovisual distraction intervention.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain During Intravenous Cannulation
Tijdsspanne: 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.
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Immediately after intravenous cannulation
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Anxiety Before and After Intravenous Cannulation
Tijdsspanne: Immediately before and immediately after intravenous cannulation
|
Anxety was assesed using the scale .Higher scores indicate greater anxiety.
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Immediately before and immediately after intravenous cannulation
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2021/284
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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