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Virtual Reality for Pain Management Study

1 czerwca 2021 zaktualizowane przez: Mark B. Powers, University of Texas at Austin
Virtual Reality (VR) is one non-pharmacological method that has shown promise as an effective means of decreasing pain levels following treatment, and for significant periods of time. Additionally, neurobiology studies of VR have demonstrated a decrease in brain activity associated with pain. While VR is clearly a promising, drug-free option for pain treatment, existing VR systems are expensive and use unconvincing graphics. Recent advances in VR technology (i.e., improved realism and immersion using 360-degree 3D technology and more affordable delivery systems) allow the development of more realistic and more cost-effective applications. Capitalizing on these advances and the investigators' experiences with VR intervention development and evaluation, the current study will test a state-of-the-art VR experience in pain management intervention (Live-Action 360° Video Virtual Reality(VVR)) and compare it to established standard computer generated imagery (CGI) 360° VVR content for pain management intervention in a medical setting. The participant's participation will help the investigators determine which VR intervention is most effective in reducing acute pain in hospital patients.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

103

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78712
        • University of Texas at Austin

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Between the ages of 18 and 65
  • Reports experiencing current pain not typical of day-to-day experience during Pre-Treatment Pain Questionnaire at the onset of study visit by answering "Yes" to the first question of the questionnaire. There is no specific threshold of how much pain the participant must be in to be eligible for this study. The participant must be experiencing current pain that is not related to day-to-day, normal experiences (such as minor headaches, sprains, and toothaches).
  • Scores a 15 on the Glasgow Coma Scale and a 7 or above on the abbreviated Mini Mental Status Exam.
  • Patient in the acute and critical palliative care units, post surgical units, or acute care orthopedic units at University Medical Center Brackenridge in Austin, TX.
  • Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.

Exclusion Criteria:

  • Hearing or visually impaired where participant cannot use the Samsung Gear VR.
  • Does not report experiencing current pain during Pre-Treatment Pain Questionnaire at the onset of study visit.
  • Scores below a 15 on the Glasgow Coma Scale and/or below a 7 on the abbreviated Mini Mental Status Exam
  • Limited mental competency and the inability to give informed, voluntary, written consent to participate.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Live-Action 360° Video Virtual Reality
Urządzenie: Live-Action 360° Video Virtual Reality
360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.
Aktywny komparator: CGI 360° Video Virtual Reality
Urządzenie: CGI 360° Video Virtual Reality
Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
Brak interwencji: Waitlist
Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Post-Treatment Pain Questionnaire
Ramy czasowe: Immediately following intervention
The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current
Immediately following intervention

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Follow-Up Pain Questionnaire
Ramy czasowe: Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current
Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
Presence Inventory
Ramy czasowe: Immediately following intervention
Self-report measure that assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. Spatial presence has a total of 3 questions for a total score of 30, and higher values mean increased spatial prescence. Ecological Validity has a total of 4 questions for a total score of 40 and higher values mean increased ecological validity. Higher for these two subscales indicate a better outcome. Negative Effects has a total of 4 questions for a total score of 40, and higher values mean more negative effects. Higher scores for this subscale indicate a worse outcome. Questions on the scale are summed.
Immediately following intervention
Absorption Survey
Ramy czasowe: Immediately after intervention
Self-report measure that assesses participant engagement with the virtual world. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions with a total score of 120. Higher scores indicate a better outcome and increased participant engagement.
Immediately after intervention
Present Mood Questionnaire
Ramy czasowe: Every 10 minutes for 40 minutes following intervention
The Present Mood Questionnaire was used to assess the participant's current mood. The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil. It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden. Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.
Every 10 minutes for 40 minutes following intervention
Attitudes Toward the Experience Survey
Ramy czasowe: Immediately after intervention
Self-report measure that assesses the participant's attitude toward the VR experience. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions for a total score of 120. Higher scores mean a more positive attitude towards the experience and is a better outcome.
Immediately after intervention

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Texas at Austin

Współpracownicy

Seton Healthcare Family

Śledczy

  • Główny śledczy: Mark Powers, Ph.D., University of Texas at Austin

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2017

Zakończenie podstawowe (Rzeczywisty)

1 lipca 2018

Ukończenie studiów (Rzeczywisty)

1 lipca 2018

Daty rejestracji na studia

Pierwszy przesłany

15 grudnia 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 grudnia 2016

Pierwszy wysłany (Oszacować)

19 grudnia 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 czerwca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 czerwca 2021

Ostatnia weryfikacja

1 czerwca 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2016-09-0140

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

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