- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07740850
Virtual Reality for Procedural Pain During IV Cannulation in Children (VR-PED)
The Impact of Virtual Reality Distraction on Procedural Pain, Duration, and Parental Satisfaction During Intravenous Cannulation and Blood Sampling in the Pediatric Emergency Department: A Prospective Quasi-Experimental Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Painful procedures such as intravenous cannulation and venous blood sampling are common in pediatric emergency departments and may lead to distress, anxiety, and negative healthcare experiences. Virtual reality (VR) has emerged as a non-pharmacological intervention that may reduce procedural pain through immersive distraction.
This prospective quasi-experimental study was conducted in a tertiary pediatric emergency department between September 2024 and September 2025. A total of 150 children aged 6-11 years requiring intravenous cannulation or venous blood sampling were included. Participants were enrolled sequentially, with 100 children assigned to the VR group and 50 to standard care. The VR intervention consisted of age-appropriate audiovisual content delivered through a VR headset during the procedure.
The primary outcome was procedure-related pain measured using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes included procedural duration, cooperation, first-attempt success, behavioral distress, parental satisfaction, and VR response. The study aimed to assess whether VR distraction may improve procedural experience and reduce procedure-related pain in pediatric emergency settings.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Izmir, Tyrkiet (Türkiye), 35100
- Ege university
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Children aged 6-11 years
- Requirement for intravenous cannulation or venous blood sampling in the -pediatric emergency department
- Ability to understand and engage with virtual reality content
- Written informed consent obtained from parent or legal guardian
Exclusion Criteria:
- Visual or hearing impairment preventing VR use
- Neurological or developmental disorders affecting communication or cooperation
- Altered level of consciousness
- Hemodynamic instability requiring immediate intervention
- Previous participation in the study
- Refusal of participation by the child or parent/legal guardian
- Contraindications to virtual reality exposure (e.g., severe motion sickness or intolerance)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Virtual Reality Group
Children received age-appropriate audiovisual distraction through a virtual reality headset during intravenous cannulation or venous blood sampling procedures.
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Participants received age-appropriate audiovisual distraction through a virtual reality headset (Meta Quest 3S) during intravenous cannulation or venous blood sampling.
The intervention aimed to reduce procedural pain and distress by redirecting attention away from the procedure toward immersive VR content.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Procedure-related pain
Tidsramme: Immediately after the procedure
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Procedure-related pain assessed using the Wong-Baker FACES Pain Rating Scale (WBFPS) following intravenous cannulation or venous blood sampling.
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Immediately after the procedure
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EGE-ETHICS-22-5.1T-33
- Project No: 32350 (Andet bevillings-/finansieringsnummer: Ege University Scientific Research Projects Coordination Unit)
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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