Clinical trial NCT02997085: Virtual Reality for Pain Management Study
Official title: Virtual Reality for Pain Management Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: Pain
Virtual Reality
Opioid
Prescription pain reliever
Treatment
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Seton Healthcare Family
First posted: 2016-12-19
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Post-Treatment Pain Questionnaire
timeFrame: Immediately following intervention
Secondary outcomes:
measure: Follow-Up Pain Questionnaire
timeFrame: Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
measure: Presence Inventory
timeFrame: Immediately following intervention
measure: Absorption Survey
timeFrame: Immediately after intervention
measure: Present Mood Questionnaire
timeFrame: Every 10 minutes for 40 minutes following intervention
measure: Attitudes Toward the Experience Survey
timeFrame: Immediately after intervention
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Mark Powers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: