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Clinical Trials/NCT02997085
NCT02997085
Completed
Not Applicable

Virtual Reality for Pain Management Study

University of Texas at Austin1 site in 1 country103 target enrollmentJanuary 2017
ConditionsPain, Acute

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
University of Texas at Austin
Enrollment
103
Locations
1
Primary Endpoint
Post-Treatment Pain Questionnaire
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
July 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mark B. Powers

Research Associate Professor

University of Texas at Austin

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Post-Treatment Pain Questionnaire

Time Frame: 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

Secondary Outcomes

  • Presence Inventory(Immediately following intervention)
  • Follow-Up Pain Questionnaire(Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.)
  • Present Mood Questionnaire(Every 10 minutes for 40 minutes following intervention)
  • Attitudes Toward the Experience Survey(Immediately after intervention)
  • Absorption Survey(Immediately after intervention)

Study Sites (1)

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