Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization
20. september 2018 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
64
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6H 3N1
- Rekruttering
- BC Children's Hospital
-
Kontakt:
- Ran D Goldman, MD
- Telefonnummer: 7333 604-875-2345
- E-mail: rgoldman@cw.bc.ca
-
Underforsker:
- Amir Behboudi, MD
-
-
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
6 år til 16 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Kontrol (Standard-of-Care)
Deltagerne bliver distraheret med Standard-of-Care af læger, sygeplejersker, praktiserende sygeplejersker, børnelivsspecialister og/eller forældre.
|
|
|
Eksperimentel: Virtual Reality
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during an IV start.
|
Deltagerne bærer et Virtual Reality-headset, der består af en ASUS-telefon og et VOX+ Z3 3D Virtual Reality-headset.
Telefonen kører VR Roller Coaster-appen for at producere det virtuelle miljø.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain using the Faces Pain Scale - Revised.
Tidsramme: Pain is reported by children immediately following completion of the IV start
|
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.
|
Pain is reported by children immediately following completion of the IV start
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Medicin dosis
Tidsramme: Disse vil blive registreret under proceduren og umiddelbart efter proceduren ved hjælp af patientskemaet og sygeplejenotater
|
Hvor meget topiske eller lokalbedøvelsesmidler bruges, og hvornår de bruges (24 timers tid); hvor meget beroligende midler bruges, og hvornår de bruges (24 timers tid); hvor meget analgetika der bruges og hvornår de bruges (24 timers tid).
|
Disse vil blive registreret under proceduren og umiddelbart efter proceduren ved hjælp af patientskemaet og sygeplejenotater
|
|
Anxiety using the Venham Situational Anxiety Score
Tidsramme: Anxiety is reported by children immediately following completion of the IV start
|
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).
|
Anxiety is reported by children immediately following completion of the IV start
|
|
Patient Satisfaction determined by Global Rating Scale
Tidsramme: Satisfaction questions are reported by children immediately following completion of the IV start
|
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.
|
Satisfaction questions are reported by children immediately following completion of the IV start
|
|
Patient Satisfaction determined qualitatively by an open ended question
Tidsramme: Satisfaction questions are reported by children immediately following completion of the IV start
|
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).
|
Satisfaction questions are reported by children immediately following completion of the IV start
|
|
Parent Satisfaction determined qualitatively by an open ended question
Tidsramme: Satisfaction question is reported by parents immediately following completion of the IV start
|
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).
|
Satisfaction question is reported by parents immediately following completion of the IV start
|
|
Number of IV Trials Until Success
Tidsramme: This number will be collected during the procedure
|
How many attempts the nurses need to get a functional IV catheter (concealed objective to avoid a Hawthorne effect).
|
This number will be collected during the procedure
|
|
Timing
Tidsramme: Documented immediately after patient and family given discharge paperwork
|
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).
|
Documented immediately after patient and family given discharge paperwork
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ran D Goldman, MD, University of British Columbia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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)
2. maj 2018
Primær færdiggørelse (Forventet)
1. maj 2019
Studieafslutning (Forventet)
1. maj 2019
Datoer for studieregistrering
Først indsendt
5. juli 2018
Først indsendt, der opfyldte QC-kriterier
20. september 2018
Først opslået (Faktiske)
24. september 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. september 2018
Sidst verificeret
1. september 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- H18-00771
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .