Virtual Reality for Pain Management Study

Not Applicable

Completed

Conditions: Pain, Acute

Interventions: Device: Live-Action 360° Video Virtual Reality
Device: CGI 360° Video Virtual Reality

Registration Number: NCT02997085

Lead Sponsor: University of Texas at Austin

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 103

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Live-Action 360° Video Virtual Reality	Live-Action 360° Video Virtual Reality	-
CGI 360° Video Virtual Reality	CGI 360° Video Virtual Reality	-

Primary Outcome Measures

Name	Time	Method
Post-Treatment Pain Questionnaire	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 Outcome Measures

Name	Time	Method
Presence Inventory	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. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. Spatial presence has a total of 3 questions for a total score of 30, and higher values mean increased spatial prescence. Ecological Validity has a total of 4 questions for a total score of 40 and higher values mean increased ecological validity. Higher for these two subscales indicate a better outcome. Negative Effects has a total of 4 questions for a total score of 40, and higher values mean more negative effects. Higher scores for this subscale indicate a worse outcome. Questions on the scale are summed.
Follow-Up Pain Questionnaire	Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.	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
Present Mood Questionnaire	Every 10 minutes for 40 minutes following intervention	The Present Mood Questionnaire was used to assess the participant's current mood. The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil. It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden. Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.
Attitudes Toward the Experience Survey	Immediately after intervention	Self-report measure that assesses the participant's attitude toward the VR experience. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions for a total score of 120. Higher scores mean a more positive attitude towards the experience and is a better outcome.
Absorption Survey	Immediately after intervention	Self-report measure that assesses participant engagement with the virtual world. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions with a total score of 120. Higher scores indicate a better outcome and increased participant engagement.