- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Kütahya
-
Kütahya, Kütahya, Tyrkia (Türkiye), 4300
- Kütahya Evliya Çelebi Training and Research Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Ingen inngripen: control group
Children underwent intravenous cannulation according to routine clinical practice without any audiovisual distraction intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain During Intravenous Cannulation
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety Before and After Intravenous Cannulation
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2021/284
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