Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization
20. september 2018 oppdatert av: Ran Goldman, University of British Columbia
A Pragmatic Randomized Controlled Trial of Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization
Children often need an intravenous catheter placement for delivery of fluids and medications, a procedure associated with pain and anxiety. In the Emergency Department topical anesthetics are frequently used.
Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.
This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to topical anaesthetics during IV placement procedure. Investigators will measure pain, anxiety and satisfaction, amount of analgesics used and the level of success in placing the IV and compare between the two groups.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
64
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3N1
- Rekruttering
- BC Children's Hospital
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Ta kontakt med:
- Ran D Goldman, MD
- Telefonnummer: 7333 604-875-2345
- E-post: rgoldman@cw.bc.ca
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Underetterforsker:
- Amir Behboudi, MD
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 år til 16 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Children age 6 - <17
- The managing physician determines a need for an intravenous catheterization (IV) procedure
- Parents will sign a consent form and children will sign an assent form
Exclusion Criteria:
- Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, others)
- Triage Category 1 (resuscitation)
- Facial features or injury prohibiting wearing the VR goggles
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
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 |
|---|---|
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Ingen inngripen: Kontroll (Standard-of-Care)
Deltakerne blir distrahert med Standard-of-Care av leger, sykepleiere, sykepleiere, spesialister i barneliv og/eller foreldre.
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Eksperimentell: Virtual Reality
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during an IV start.
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Deltakerne har på seg et Virtual Reality-headset som består av en ASUS-telefon og et VOX+ Z3 3D Virtual Reality-headset.
Telefonen kjører VR Roller Coaster-appen for å produsere det virtuelle miljøet.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain using the Faces Pain Scale - Revised.
Tidsramme: Pain is reported by children immediately following completion of the IV start
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Level of pain as reported by children using Faces Pain Scale - Revised.
The scale includes six faces that represent progressively more intense features of pain.
Children point to the face that best represents their current level of pain.
The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain).
The scale increase in increments of 2.
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Pain is reported by children immediately following completion of the IV start
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Medisindose
Tidsramme: Disse vil bli registrert under prosedyren og umiddelbart etter prosedyren ved hjelp av pasientskjemaet og sykepleiernotater
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Hvor mye lokal- eller lokalbedøvelse brukes og når de brukes (24 timers tid); hvor mye beroligende midler brukes og når de brukes (24 timers tid); hvor mye smertestillende som brukes og når de brukes (24 timers tid).
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Disse vil bli registrert under prosedyren og umiddelbart etter prosedyren ved hjelp av pasientskjemaet og sykepleiernotater
|
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Anxiety using the Venham Situational Anxiety Score
Tidsramme: Anxiety is reported by children immediately following completion of the IV start
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Level of Situational Anxiety as reported by children using the Venham Situational Anxiety Score.
This scale includes 8 sets of 2 images of children which represent differing levels of anxiety.
Children point to the child that best represents them in that instance.
In each set of 2 images of children, one represents greater anxiety (scored as 1) and one represents lesser anxiety (scored as 0).
The points from each set of images are totaled.
The minimum score is 0 (least anxious) and maximum score is 8 (most anxious).
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Anxiety is reported by children immediately following completion of the IV start
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Patient Satisfaction determined by Global Rating Scale
Tidsramme: Satisfaction questions are reported by children immediately following completion of the IV start
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Satisfaction from the procedure is determined by asking 4 questions on a global rating scale.
This scale goes from 0-10 where 0 represents "not very much" and 10 represents "very much."
Questions are developed from previous virtual reality research.
"Overall, how satisfied are you with pain management during plastic surgery?" "Overall, how satisfied are you with anxiety management during plastic surgery?" "To what extent did you feel like you went into the virtual world?" "How much fun did you have while playing in the virtual world?"
These questions will be analyzed individually not summed.
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Satisfaction questions are reported by children immediately following completion of the IV start
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Patient Satisfaction determined qualitatively by an open ended question
Tidsramme: Satisfaction questions are reported by children immediately following completion of the IV start
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Satisfaction from the procedure is determined qualitatively.
Children are asked "What is your opinion on how the procedure went?" Answers will be recorded in writing and be assessed for themes (similar words, positive or negative language).
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Satisfaction questions are reported by children immediately following completion of the IV start
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Parent Satisfaction determined qualitatively by an open ended question
Tidsramme: Satisfaction question is reported by parents immediately following completion of the IV start
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Satisfaction from the procedure is determined qualitatively.
Parents are asked "What is your opinion on how the procedure went?" Answers will be recorded in writing and be assessed for themes (similar words, positive or negative language).
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Satisfaction question is reported by parents immediately following completion of the IV start
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Number of IV Trials Until Success
Tidsramme: This number will be collected during the procedure
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How many attempts the nurses need to get a functional IV catheter (concealed objective to avoid a Hawthorne effect).
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This number will be collected during the procedure
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Timing
Tidsramme: Documented immediately after patient and family given discharge paperwork
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Time in minutes from readiness for procedure (availability of child, staff and equipment) until completion of procedure (nurse does not need to touch the patient anymore) and until discharged from the emergency department (given discharge paperwork).
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Documented immediately after patient and family given discharge paperwork
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ran D Goldman, MD, University of British Columbia
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. mai 2018
Primær fullføring (Forventet)
1. mai 2019
Studiet fullført (Forventet)
1. mai 2019
Datoer for studieregistrering
Først innsendt
5. juli 2018
Først innsendt som oppfylte QC-kriteriene
20. september 2018
Først lagt ut (Faktiske)
24. september 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. september 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. september 2018
Sist bekreftet
1. september 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- H18-00771
Plan for individuelle deltakerdata (IPD)
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NEI
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