Virtual Reality for Pain Management Study

NCT02997085 | Completed Results

• 1 other identifier: 2016-09-0140
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Keywords

Pain; Virtual Reality; Opioid; Prescription pain reliever; Treatment

Outcome Measures

Primary Outcomes (1)

• Post-Treatment Pain Questionnaire

  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

Secondary Outcomes (5)

• Follow-Up Pain Questionnaire

  Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.

• Presence Inventory

  Immediately following intervention

• Absorption Survey

  Immediately after intervention

• Present Mood Questionnaire

  Every 10 minutes for 40 minutes following intervention

• Attitudes Toward the Experience Survey

  Immediately after intervention

Study Arms (3)

Live-Action 360° Video Virtual Reality

EXPERIMENTAL

Device: Live-Action 360° Video Virtual Reality

CGI 360° Video Virtual Reality

ACTIVE COMPARATOR

Device: CGI 360° Video Virtual Reality

Waitlist

NO INTERVENTION

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.

Interventions

Live-Action 360° Video Virtual Reality DEVICE

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.

Live-Action 360° Video Virtual Reality

CGI 360° Video Virtual Reality DEVICE

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.

CGI 360° Video Virtual Reality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead
• Seton Healthcare Family: collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Mark Powers
• Organization: Baylor Scott & White Research Institute

Mark.Powers1@bswhealth.org

2148652409

Study Officials

• Mark Powers, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 23, 2021
• Results First Posted: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)