Pain, Acute
Conditions
Keywords
Pain, Virtual Reality, Opioid, Prescription pain reliever, 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.
Interventions
DEVICELive-Action 360° Video Virtual Reality
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.
DEVICECGI 360° Video Virtual Reality
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.
Sponsors
Seton Healthcare Family
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Live-Action 360° Video Virtual Reality Live-Action 360° Video Virtual Reality: 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. | 34 |
| CGI 360° Video Virtual Reality CGI 360° Video Virtual Reality: 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. | 35 |
| Waitlist 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. | 34 |
| Total | 103 |
Baseline characteristics
| Characteristic | Live-Action 360° Video Virtual Reality | CGI 360° Video Virtual Reality | Waitlist | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 34 Participants | 31 Participants | 96 Participants |
| Age, Continuous | 41.03 years STANDARD_DEVIATION 14.14 | 43.83 years STANDARD_DEVIATION 13.51 | 44.62 years STANDARD_DEVIATION 16.17 | 43.17 years STANDARD_DEVIATION 14.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 7 Participants | 6 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 28 Participants | 28 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Pain Questionnaire | 5.97 units on a scale STANDARD_DEVIATION 1.88 | 5.22 units on a scale STANDARD_DEVIATION 2.02 | 6.29 units on a scale STANDARD_DEVIATION 2.37 | 5.83 units on a scale STANDARD_DEVIATION 2.27 |
| Present Mood Questionnaire Anxiety | 4 units on a scale STANDARD_DEVIATION 3.47 | 2.86 units on a scale STANDARD_DEVIATION 3.05 | 3.18 units on a scale STANDARD_DEVIATION 3.33 | 3.37 units on a scale STANDARD_DEVIATION 3.29 |
| Present Mood Questionnaire Depression | 2.62 units on a scale STANDARD_DEVIATION 3 | 2.17 units on a scale STANDARD_DEVIATION 2.71 | 2.15 units on a scale STANDARD_DEVIATION 2.35 | 2.33 units on a scale STANDARD_DEVIATION 2.68 |
| Present Mood Questionnaire Happy | 4.12 units on a scale STANDARD_DEVIATION 3.22 | 4.71 units on a scale STANDARD_DEVIATION 3.27 | 5.62 units on a scale STANDARD_DEVIATION 3.58 | 4.80 units on a scale STANDARD_DEVIATION 3.4 |
| Present Mood Questionnaire Tranquil | 5.44 units on a scale STANDARD_DEVIATION 3.25 | 6.06 units on a scale STANDARD_DEVIATION 2.78 | 6.21 units on a scale STANDARD_DEVIATION 2.71 | 5.86 units on a scale STANDARD_DEVIATION 2.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 6 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 27 Participants | 29 Participants | 28 Participants | 84 Participants |
| Region of Enrollment United States | 34 participants | 35 participants | 34 participants | 103 participants |
| Sex/Gender, Customized Female | 18 Participants | 12 Participants | 11 Participants | 41 Participants |
| Sex/Gender, Customized Male | 16 Participants | 23 Participants | 22 Participants | 61 Participants |
| Sex/Gender, Customized Prefer Not to Report | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 37 |
| other Total, other adverse events | 9 / 66 | 7 / 37 |
| serious Total, serious adverse events | 0 / 66 | 0 / 37 |
Outcome results
Primary
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
Time frame: Immediately following intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Live-Action 360° Video Virtual Reality | Post-Treatment Pain Questionnaire | 3.03 score on a scale | Standard Deviation 2.3 |
| CGI 360° Video Virtual Reality | Post-Treatment Pain Questionnaire | 2.77 score on a scale | Standard Deviation 2.13 |
| Waitlist | Post-Treatment Pain Questionnaire | 6.37 score on a scale | Standard Deviation 2.23 |
Secondary
Absorption Survey
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.
Time frame: Immediately after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Live-Action 360° Video Virtual Reality | Absorption Survey | 104.32 units on a scale | Standard Deviation 16.52 |
| CGI 360° Video Virtual Reality | Absorption Survey | 96.2 units on a scale | Standard Deviation 18.34 |
Secondary
Attitudes Toward the Experience Survey
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.
Time frame: Immediately after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Live-Action 360° Video Virtual Reality | Attitudes Toward the Experience Survey | 74.35 units on a scale | Standard Deviation 10.93 |
| CGI 360° Video Virtual Reality | Attitudes Toward the Experience Survey | 67.51 units on a scale | Standard Deviation 16.49 |
Secondary
Follow-Up 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
Time frame: Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Live-Action 360° Video Virtual Reality | Follow-Up Pain Questionnaire | 4.2 units on a scale | Standard Deviation 2.32 |
| CGI 360° Video Virtual Reality | Follow-Up Pain Questionnaire | 4.14 units on a scale | Standard Deviation 2.72 |
| Waitlist | Follow-Up Pain Questionnaire | 3.7 units on a scale | Standard Deviation 3.04 |
Secondary
Presence Inventory
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.
Time frame: Immediately following intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Live-Action 360° Video Virtual Reality | Presence Inventory | Ecological Validity | 35.06 units on a scale | Standard Deviation 7.69 |
| Live-Action 360° Video Virtual Reality | Presence Inventory | Spatial Presence | 25.79 units on a scale | Standard Deviation 6.99 |
| Live-Action 360° Video Virtual Reality | Presence Inventory | Negative Effects | 1.09 units on a scale | Standard Deviation 2.23 |
| CGI 360° Video Virtual Reality | Presence Inventory | Spatial Presence | 22.18 units on a scale | Standard Deviation 8.97 |
| CGI 360° Video Virtual Reality | Presence Inventory | Negative Effects | 2 units on a scale | Standard Deviation 5.68 |
| CGI 360° Video Virtual Reality | Presence Inventory | Ecological Validity | 25.62 units on a scale | Standard Deviation 12.09 |
Secondary
Present Mood Questionnaire
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.
Time frame: Every 10 minutes for 40 minutes following intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Live-Action 360° Video Virtual Reality | Present Mood Questionnaire | Depression | .7 units on a scale | Standard Deviation 1.45 |
| Live-Action 360° Video Virtual Reality | Present Mood Questionnaire | Anxiety | 1.24 units on a scale | Standard Deviation 3.18 |
| Live-Action 360° Video Virtual Reality | Present Mood Questionnaire | Happy | 6.52 units on a scale | Standard Deviation 2.54 |
| Live-Action 360° Video Virtual Reality | Present Mood Questionnaire | Tranquil | 7.7 units on a scale | Standard Deviation 2.3 |
| CGI 360° Video Virtual Reality | Present Mood Questionnaire | Tranquil | 7.62 units on a scale | Standard Deviation 2.71 |
| CGI 360° Video Virtual Reality | Present Mood Questionnaire | Depression | .85 units on a scale | Standard Deviation 1.88 |
| CGI 360° Video Virtual Reality | Present Mood Questionnaire | Happy | 6.24 units on a scale | Standard Deviation 3.38 |
| CGI 360° Video Virtual Reality | Present Mood Questionnaire | Anxiety | 1.21 units on a scale | Standard Deviation 2.27 |
| Waitlist | Present Mood Questionnaire | Tranquil | 6.56 units on a scale | Standard Deviation 2.65 |
| Waitlist | Present Mood Questionnaire | Anxiety | 2.25 units on a scale | Standard Deviation 2.76 |
| Waitlist | Present Mood Questionnaire | Happy | 5.34 units on a scale | Standard Deviation 3.39 |
| Waitlist | Present Mood Questionnaire | Depression | 2.25 units on a scale | Standard Deviation 3.13 |