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Virtual Reality Distraction During Pediatric Intravenous Line Placement

6. oktober 2017 opdateret af: University of Texas at Austin

Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study

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.

Studieoversigt

Status

Ukendt

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

Interventionel

Tilmelding (Forventet)

116

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Texas
      • Austin, Texas, Forenede Stater, 78723
        • Rekruttering
        • Dell Children's Medical Center of Central Texas
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

4 år til 17 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. september 2017

Primær færdiggørelse (Forventet)

1. januar 2018

Studieafslutning (Forventet)

1. januar 2018

Datoer for studieregistrering

Først indsendt

28. september 2017

Først indsendt, der opfyldte QC-kriterier

6. oktober 2017

Først opslået (Faktiske)

9. oktober 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ASalinas

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Kliniske forsøg med Pediatric IV Placement

Kliniske forsøg med Virtual Reality

3
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