- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03304769
Virtual Reality Distraction During Pediatric Intravenous Line Placement
Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Children often describe procedures involving needles as the most stressful portion of the hospital experience. 1,2 Many studies involving the perception of pain have highlighted the importance of attention for the perception of pain, and, conversely, the benefit of distraction for decreasing pain perception. 3,4 Virtual reality technologies (VR) have been shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a number of different ways. 5,6 While small studies have demonstrated the use of VR to be effective in diminishing pain during intravenous (IV) placement for outpatient imaging in pediatric patients aged 8-12, there have not been large-scale studies assessing the use of VR during IV placement in the Pediatric Emergency Department. 7 Studies examining the use of VR during venipuncture and IV placement also frequently focus on self-reported or parent-reported pain, rather than objectively quantifying number of IV sticks and time to successful IV placement.8 Additionally, the pediatric age ranges which benefit from VR have not been well-established, with some studies citing benefits only in patients over 10 years of age, and others showing improvements in all age groups.7,9,10
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Anna K Schlechter, MD
- Telefonnummer: 512-662-6512
- E-mail: anna.schlechter@gmail.com
Undersøgelse Kontakt Backup
- Navn: Matthew Wilkinson, MD
- Telefonnummer: 512-547-8362
- E-mail: mhwilkinson@ascension.org
Studiesteder
-
-
Texas
-
Austin, Texas, Forenede Stater, 78723
- Rekruttering
- Dell Children's Medical Center of Central Texas
-
Kontakt:
- Matthew Wilkinson, MD
- Telefonnummer: 512-547-8362
- E-mail: mhwilkinson@ascension.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patient aged 4-17 years
- Requiring IV placement
- Child Life unavailable
Exclusion Criteria:
- Previous enrollment in the study
- Physically/ developmentally unable to tolerate headset
- Skin/eye pathology
- Critically ill patient
- Language other than English or Spanish
- Student Nurse placing IV
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: IV placement no Virtual reality
Patient will have IV placed in traditional manner, with no virtual reality headset
|
|
Eksperimentel: IV placement with Virtual Reality
Patient will have IV placed with Virtual Reality headset distraction
|
Virtual Reality Headset applied to the patient during placement of IV.
Control is patient group without headset applied.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Successful IV placement with first attempt
Tidsramme: 6 months
|
success in first attempt in VR group vs non VR group
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
number of attempts before successfully establishing IV
Tidsramme: 6 months
|
number of attempts before successful IV placement in VR group vs non VR group
|
6 months
|
time to establishing successful IV
Tidsramme: 6 months
|
time to establishing successful IV in VR group vs non VR group
|
6 months
|
Pre vs Post FACES revised pain scale parents
Tidsramme: 6 months
|
Pre vs Post FACES pain scale in VR group vs non VR group
|
6 months
|
Pre vs Post FACES revised pain Scale patients
Tidsramme: 6 months
|
Pre vs Post FACES pain scale in VR group vs non VR group
|
6 months
|
Pre vs Post Likert-Type Anxiety Scale - parents
Tidsramme: 6 months
|
Pre vs Post Likert-Type Anxiety Scale of parents in VR group vs non VR group
|
6 months
|
Pre vs Post Likert-Type Anxiety Scale- patients
Tidsramme: 6 months
|
Pre vs Post Likert-Type Anxiety Scale of patients in VR group vs non VR group
|
6 months
|
age range of patients that tolerate VR
Tidsramme: 6 months
|
Which of evaluated age range of 4-17 years tolerate VR placement
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Andre undersøgelses-id-numre
- ASalinas
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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