Virtual Reality for Pain Management Study

The University of Texas System (UT)

Status: Completed

Conditions: Pain, Acute

Treatments: Device: Live-Action 360° Video Virtual Reality; Device: CGI 360° Video Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT02997085

2016-09-0140

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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103 participants in 3 patient groups

Live-Action 360° Video Virtual Reality

Experimental group

Treatment:

Device: Live-Action 360° Video Virtual Reality

CGI 360° Video Virtual Reality

Active Comparator group

Treatment:

Device: CGI 360° Video Virtual Reality

Waitlist

No Intervention group

Description:

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.