Virtual Reality for Pain Management Study

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2020

Interventions

  • Device: 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.
  • Device: 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.

Arms, Groups and Cohorts

  • Experimental: Live-Action 360° Video Virtual Reality
  • Active Comparator: CGI 360° Video Virtual Reality
  • No Intervention: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Post-Treatment Pain Questionnaire
    • Time Frame: Immediately following intervention
    • Self-report measure that assesses pain experienced during VR intervention.

Secondary Measures

  • Follow-Up Pain Questionnaire
    • Time Frame: Every 10 minutes for 40 minutes following intervention and 1 week following intervention.
    • Self-report measure that assesses pain experienced after the VR intervention.
  • Presence Inventory
    • Time Frame: 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.
  • Absorption Survey
    • Time Frame: Immediately after intervention
    • Self-report measure that assesses participant engagement with the virtual world.
  • Transportation Survey
    • Time Frame: Immediately after intervention
    • Self-report measure that will be used to measure the extent that the participant was able to transport themselves into the virtual world.
  • VR Mood Survey
    • Time Frame: Immediately after intervention
    • Self-report measure that assesses the participant’s mood during the VR session.
  • Attitudes Toward the Experience Survey
    • Time Frame: Immediately after intervention
    • Self-report measure that assesses the participant’s attitude toward the VR experience.
  • Patient Satisfaction Survey
    • Time Frame: 1-week following intervention
    • Self-report measure that assesses the participant acceptability and satisfaction of the virtual reality treatment 1-week following completion of the study.
  • Present Mood Questionnaire
    • Time Frame: Every 10 minutes for 40 minutes following intervention and 1 week following intervention.
    • Self-report measure to assess participant’s current mood.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Texas at Austin
  • Collaborator
    • Seton Healthcare Family
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mark B. Powers, Research Associate Professor – University of Texas at Austin
  • Overall Official(s)
    • Mark Powers, Ph.D., Principal Investigator, University of Texas at Austin

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