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Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room

1. desember 2019 oppdatert av: Daniel Marc Fein, Montefiore Medical Center

A Feasibility Study for the Use of Virtual Reality to Reduce Procedural Anxiety for Children Undergoing Laceration Repair in the Pediatric Emergency Room

The investigators propose a pilot study to examine the feasibility of utilizing immersive virtual reality to reduce procedural anxiety in children undergoing non-facial laceration repair in the Pediatric Emergency Department.

The investigators hypothesize that virtual reality will be well-received by patients and their caregivers, and that the anxiety provoked by laceration repair will be mitigated by the immersive virtual reality experience.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • Bronx, New York, Forente stater, 10467
        • Children's Hospital at Montefiore

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

5 år til 13 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • children 5-13 years of age
  • present to ED during the study period with non-facial lacerations
  • patient to undergo wound closure with sutures

Exclusion Criteria:

  • Patients with lacerations on the head/face
  • Patients with lacerations sustained in conjunction with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
  • Patients who sustained a laceration in conjunction with an open fracture
  • Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
  • Patients with a history of or current symptoms of vertigo
  • Patients who are blind
  • Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
  • Patients on whom the VR headset does not fit appropriately
  • Non-English speaking patients will be excluded from this study (we do not have funds available to translate the study documents into other languages)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Virtualy Reality App
Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.
Annen: Virtual Reality App
Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
Tidsramme: from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in anxiety score
Tidsramme: from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
Change in anxiety score
Tidsramme: from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
Change in anxiety score
Tidsramme: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire
Tidsramme: Patients will fill out the questionnaire at the time their sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment

To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, participants will be asked to complete a brief questionnaire at the end of the procedure assessing their experience while using VR during the laceration repair.

These surveys address the patient's comfort and satisfaction with the technology. We have created separate patient surveys for children ages 5-7 and children ages 8-13 - these surveys have the same questions, but the answer choices are simplified from Likert Rating Scales (scale of 1 - 5) for the older children to a simple "Yes, No, I don't know" choice for the younger children. There is also a free text response question for which patients can provide additional comments or suggestions regarding their use of VR during laceration repair.
Patients will fill out the questionnaire at the time their sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire
Tidsramme: Parent/guardian will fill out the questionnaire at the time their child's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, parents/guardians will be asked to complete a brief survey at the end of the procedure assessing their comfort and satisfaction with their child's use of VR during the laceration repair. The survey contains both rating questions with Likert Rating Scales (scale of 1 - 5), yes/no questions, and questions with free text responses.
Parent/guardian will fill out the questionnaire at the time their child's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire
Tidsramme: Providers will fill out the questionnaire at the time their patient's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
The ED provider who performed the laceration repair will complete a survey at the end of the procedure assessing their satisfaction with using VR during laceration repair. The survey contains yes/no questions, multiple choice questions, and questions with free text responses.
Providers will fill out the questionnaire at the time their patient's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire
Tidsramme: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, adjunctive measures were needed during the procedure.
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Headache due to VR use as reported on a qualitative simulator sickness questionnaire
Tidsramme: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire
Tidsramme: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Nausea due to VR use as reported on a qualitative simulator sickness questionnaire
Tidsramme: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire
Tidsramme: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Barriers to the use of VR identified during this study as reported on a provider questionnaire
Tidsramme: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, barriers to the use of VR that they encountered during the procedure
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Montefiore Medical Center

Samarbeidspartnere

KindVR

Etterforskere

  • Hovedetterforsker: Daniel M Fein, MD, Montefiore Medical Center

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)

15. april 2018

Primær fullføring (Faktiske)

22. november 2019

Studiet fullført (Faktiske)

22. november 2019

Datoer for studieregistrering

Først innsendt

10. mars 2018

Først innsendt som oppfylte QC-kriteriene

16. mars 2018

Først lagt ut (Faktiske)

23. mars 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. desember 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. desember 2019

Sist bekreftet

1. desember 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2017-8466

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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