Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Using Virtual Reality Applications for Younger Patients With Chronic Pain

29. juli 2026 opdateret af: Elizabeth Pickle

Use of Virtual Reality in Outpatient Management of Pediatric Chronic Pain of Head, Neck and Upper Extremity

In this study, patients who are 7-21 years of age and have chronic pain affecting their head, neck, and/or upper limb will participate in 6 once-weekly sessions. During each of these hour-long sessions, participants will engage in physical therapy exercises, use virtual reality games focused on moving the head, neck and arm, and complete questionnaires about their pain.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Allison Park, Pennsylvania, Forenede Stater, 15101-4146
        • Children's Hospital of Pittsburgh

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

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients 7-21 years of age
  • Patients who have been evaluated in the pediatric chronic pain clinic during the enrollment period or last 12 months
  • Patients who have a diagnosis of migraine, chronic neck pain, chronic shoulder or scapular pain, chronic pain of the upper limb, complex regional pain syndrome of the upper limb, amplified musculoskeletal pain syndrome affecting the upper limb, chronic joint pain affecting the upper limb

Exclusion Criteria:

  • Patients less than 7 years or greater than 21 years of age
  • Patients who have not been evaluated in the pediatric chronic pain clinic during the enrollment period or last 12 months.
  • Patients with primary complaints of lower back pain, hip pain, knee pain, ankle pain, or abdominal pain.
  • Patients with factors limit their ability to safely tolerate wearing and operating the Meta Oculus 2 virtual reality goggles, including but not limited to claustrophobia, anxiety, vestibulo-ocular dysfunction, visual impairments, significant sitting balance impairments.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Physical Therapy and VR
Enhed: Virtual reality gaming
Participants will wear a VR headset and play games of their choosing developed by Invincikids to target mobility in the head, neck and upper extremity
Andet: Physical therapy exercises
Physical therapy exercises directed by a licensed physical therapist to improve painful area mobility and function. Participants will be classified into high, moderate, and low pain irritability groups, which will determine their exercises

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Intensity Based on Numeric Rating Scale
Tidsramme: Weekly assessment from enrollment to the end of treatment at 6 weeks
Ranges from 0 (no pain) to 10 (worst pain imaginable)
Weekly assessment from enrollment to the end of treatment at 6 weeks
Disability Classification based on the Upper Extremity Functional Scale
Tidsramme: Weekly assessment from enrollment to the end of treatment at 6 weeks
20-item questionnaire asking participant to rate difficulty of specified activities using the upper extremity with possible answers ranging from 1 (extreme difficulty or unable to perform activity) to 4 (no difficulty).
Weekly assessment from enrollment to the end of treatment at 6 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy
Tidsramme: Weekly assessment from enrollment to the end of treatment at 6 weeks
7-item questionnaire of "How sure are you that you are able to do each of the following things when you have pain?" which can be answered very sure, pretty sure, in the middle, pretty unsure, very unsure
Weekly assessment from enrollment to the end of treatment at 6 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Catastrophizing
Tidsramme: Weekly assessment from enrollment to the end of treatment at 6 weeks
13-item questionnaire on thoughts and feelings during pain answered with not at all, mildly, moderately, severely, extremely.
Weekly assessment from enrollment to the end of treatment at 6 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Interference
Tidsramme: Weekly assessment from enrollment until the end of treatment at 6 weeks
15-item questionnaire about sleep interference with each question answered never, almost never, sometimes, almost always, always
Weekly assessment from enrollment until the end of treatment at 6 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experience
Tidsramme: Weekly assessment from enrollment to the end of treatment at 6 weeks
19-item questionnaire about psychological stress experience which can be answered never, rarely, sometimes, often, always
Weekly assessment from enrollment to the end of treatment at 6 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms
Tidsramme: Weekly assessment from enrollment to the end of treatment at 6 weeks
14-item questionnaire about depressive symptoms that can be answered never, almost never, sometimes, often, almost always
Weekly assessment from enrollment to the end of treatment at 6 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety
Tidsramme: Weekly assessment from enrollment to the end of treatment at 6 weeks
15-item questionnaire that can be answered never, almost never, sometimes, often, almost always
Weekly assessment from enrollment to the end of treatment at 6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Elizabeth Pickle

Efterforskere

  • Ledende efterforsker: Elizabeth A Pickle, MD, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh

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.

Generelle publikationer

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)

24. juli 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY25080026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

No current plans exist to share this data.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

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 .

Abonner