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Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department

7. října 2019 aktualizováno: Jennifer Stinson, The Hospital for Sick Children

Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department: A Feasibility Pilot Study

Venipuncture and intravenous (IV) access continue to be the most common causes of pain and distress among children in the pediatric emergency department. Virtual reality has been successful for reducing pain and fear in many clinical scenarios, including port access in oncology patients, anxiety disorders, phobias, burn and wound care and others. There is only one previous study examining virtual reality distraction to reduce procedural pain during IV insertion in pediatric patients and no previous studies examining this in the emergency department setting. In this study, the investigators will compare immersive virtual reality (an interactive underwater environment) to the current standard (tablet device/iPad playing a movie) for distraction to reduce procedural pain during IV insertion. The investigators hypothesize that the immersive quality of the virtual reality will reduce patient's pain scores, fear scores and tachycardia during and after the procedure, and have minimal effect on departmental flow and nursing satisfaction. If this feasibility pilot study yields positive results, the investigators plan to expand to a larger randomized control trial.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This study is a pilot randomized control trial that aims to (a) to determine the differences in self-reported and proxy-reported pain and fear during IV insertion between the interactive VR intervention and control group, and (b) to assess the feasibility (safety, acceptability) of the VR intervention to children/families and the healthcare team in the pediatric emergency department. The study will consist of two study arms, where both study arms will be screened and recruited using the same procedure. Participants will be randomized into either (1) Control group: child life specialist plays an age-appropriate video on a tablet device, or (2) Intervention (VR Distraction): child life specialist facilitates immersive VR experience. Both the intervention and control groups will receive standard medical care (e.g., topical anesthetics). A convenience sample of 80 children and adolescents with cancer (40 participants per treatment arm; 20 boys and 20 girls per treatment arm) will be recruited. In addition to usual care, children in the experimental condition will wear the VR headset plus headphones. In the control condition, children will watch a video (i.e., an age-appropriate video selected by an emergency department affiliated child life specialist) on an iPad, while wearing the same headphones as in the experimental condition. Implementation outcomes include accrual and retention rates, acceptability and technical difficulties. Effectiveness outcomes include child pain, distress, and fear, as well as parent distress.

Typ studie

Intervenční

Zápis (Aktuální)

58

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5G 1X8
        • Hospital for Sick Children

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

8 let až 18 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion criteria will be:

  1. aged 8-17 years
  2. able to speak and understand English
  3. parent/guardian present
  4. medically stable (CTAS 2, 3, 4 or 5; IV insertion +/-20 minutes will not impact the safety of the patient according to treating medical team)
  5. requires IV insertion

Exclusion criteria will be:

  1. visual, auditory or cognitive impairments precluding interaction with the VR intervention or reporting pain and fear
  2. psychiatric conditions that could be exacerbated by the VR environment (i.e. hallucinations)
  3. skin, face or ear infections or injuries, which could contaminate the intervention equipment
  4. medically unstable (CTAS 1; patient requires immediate IV insertion)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intervention Group (VR)
The patient will be allowed to 'try-out' the VR system (including all auditory and visual features) for ~5 minutes prior to the start of the procedure. In addition to usual care, consisting of child-life presence and topical analgesics if ordered by the treating medical team, children in the experimental condition will wear the VR HMD plus headphones and hold the VR controller.
Přístroj: Virtual Reality Program
VR with head mounted display (HMD) and headphones.
Aktivní komparátor: Control Group (Standard Care - Video)
The patient will be allowed to watch an age-appropriate video on a tablet device. The patient will be offered to wear the same headphones as in the experimental condition. The patient will have the tablet and headphones for ~5 minutes prior to the start of the procedure. In addition, the patient will receive standard care consisting of a child life specialist and topical analgesics (if ordered by the treating medical team).
Přístroj: iPad Tablet
iPad with headphones

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Pain Intensity
Časové okno: Baseline, 30 minutes after baseline
Using an 11 point Numerical Rating Scale (NRS) (0 being no distress at all and 10 being the most distress you can imagine this child or you having) children will self-report their pain and parents, nurses and the researcher will report children's pain BOTH prior to and following the procedure.
Baseline, 30 minutes after baseline
Change in Child Distress
Časové okno: Baseline, 30 minutes after baseline
Using an 11 point Numerical Rating Scale (NRS) (0 being no distress at all and 10 being the most distress you can imagine this child or you having) children will self-report their distress and parents, nurses and the researcher will report children's distress BOTH prior to and following the procedure
Baseline, 30 minutes after baseline
Change in Child Fear
Časové okno: Baseline, 30 minutes after baseline
Children will report fear BOTH prior to and following the procedure using the Child Fear Scale (CFS) which is a 5-face visual scale that measures fear intensity and is validated in children as young as 5 years. It consists of a 1-question scale rating fear from 0 - 4, based on the faces provided. A higher number represents higher fear intensity.
Baseline, 30 minutes after baseline
Child Pain Catastrophizing
Časové okno: Baseline
Children will report baseline tendencies to catastrophize about pain using the Pain Catastrophizing Scale - Child (PCS-C). This is a self-report measure of children's tendency to catastrophize about pain validated in children 8-18 years of age. 6-items responded to on an 11-point scale from 0 ("not at all") to 10 ("a lot"), with a higher number representing higher pain catastrophizing.
Baseline
Parent Pain Catastrophizing
Časové okno: Baseline
Parents will report baseline tendencies to catastrophize about their child's pain using the Pain Catastrophizing Scale - Parent (PCS-P), which is a self-report measure of parents' tendency to catastrophize about their child's pain validated in parents of children 8-18 years of age. 6-items responded to on an 11-point scale from 0 ("not at all") to 10 ("a lot"), with a higher number representing higher parental pain catastrophizing of their child's pain.
Baseline
Parent Distress
Časové okno: 30 minutes after baseline measures are completed
Parents will report on their own level of distress following the child's procedure using the Parent Distress Questionnaire. This measure consists of 4-items responded to on an 11-point numeric rating scale from 0 ("not at all") to 10 ("extremely"). A higher number value represents higher distress levels.
30 minutes after baseline measures are completed
Child Presence Measure
Časové okno: 30 minutes after baseline measures are completed
This child self-report measure assesses effectiveness of the immersive aspect of the VR toolkit/iPad using 12 questions, a choice of three answers ("no", "a little", and "a lot").
30 minutes after baseline measures are completed

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Recruitment log
Časové okno: through study completion, an average of 1 year
Using an investigator-generated recruitment log, accrual rates will be measured by counting the number eligible children per recruitment day, participants enrolled, reasons for ineligibility, reasons for non-participation and reasons for study attrition.
through study completion, an average of 1 year
Acceptability
Časové okno: 30 minutes after baseline measures are completed
Measured using the VR Distraction Satisfaction Questionnaire completed by children, parents and nurses and will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience.
30 minutes after baseline measures are completed
Outcome measure feasibility
Časové okno: through study completion, an average of 1 year
Will be measured as the percentage of completed outcome measures at baseline and study completion and will be recorded on the VR Distraction Activity Log.
through study completion, an average of 1 year
Technical Difficulties Log
Časové okno: through study completion, an average of 1 year
Using an investigator-generated technical difficulties log, researchers will record data related to technical difficulties associated with the VR intervention, observed difficulties in implementing the trial protocol in the clinic and time to complete IV needle insertion.
through study completion, an average of 1 year

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The Hospital for Sick Children

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. února 2018

Primární dokončení (Aktuální)

30. září 2019

Dokončení studie (Aktuální)

30. září 2019

Termíny zápisu do studia

První předloženo

19. ledna 2018

První předloženo, které splnilo kritéria kontroly kvality

9. února 2018

První zveřejněno (Aktuální)

19. února 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. října 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. října 2019

Naposledy ověřeno

1. října 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1000058799

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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