- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03304769
Virtual Reality Distraction During Pediatric Intravenous Line Placement
Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Texas
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Austin, Texas, Förenta staterna, 78723
- Rekrytering
- Dell Children's Medical Center of Central Texas
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Kontakt:
- Matthew Wilkinson, MD
- Telefonnummer: 512-547-8362
- E-post: mhwilkinson@ascension.org
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: IV placement no Virtual reality
Patient will have IV placed in traditional manner, with no virtual reality headset
|
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Successful IV placement with first attempt
Tidsram: 6 months
|
success in first attempt in VR group vs non VR group
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
number of attempts before successfully establishing IV
Tidsram: 6 months
|
number of attempts before successful IV placement in VR group vs non VR group
|
6 months
|
|
time to establishing successful IV
Tidsram: 6 months
|
time to establishing successful IV in VR group vs non VR group
|
6 months
|
|
Pre vs Post FACES revised pain scale parents
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months
|
Which of evaluated age range of 4-17 years tolerate VR placement
|
6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ASalinas
Plan för individuella deltagardata (IPD)
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