Pain, Neuropathic, Pain, Acute
Conditions
Keywords
Virtual Reality, Augmented Reality, Ice Immersion
Brief summary
The purpose of this study is to evaluate the effectiveness of different technologies, Virtual Reality and Augmented Reality with modifications as passive content, active content, cognitive load modulation, and positive encouragement coaching to increase the pain threshold as assessed by immersing a hand in ice water.
Interventions
DEVICEVR/AR
VR/AR headset with either passive or active content such as playing a game or watching a movie
OTHERIce Bath
Participants immerse hand in ice bath and starting again with their original assigned group and keep hand submerged as long as they can withstand the cold or until 4 minutes have elapsed, whichever comes first. Participants will not be told of the specifics of the time limit, to avoid competitiveness and expectations and will be asked for pain scores every 30 seconds.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Greater than 18 years of age * English speaking * Hearing intact
Exclusion criteria
* Patients who do not consent * Currently taking beta blockers or other chronotropic heart medication(s) * Have a history of severe motion sickness * Currently have nausea * Currently experiencing seizures * Are clinically unstable * Have taken pain medications in the last 12 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VR Effect on Pain Tolerence | Duration of ice bath (approximately 0 - 4 minutes) | Given that the cold pressor test produces an uncomfortable experience, we considered longer duration within the ice bath to represent increased pain tolerance. Measured in seconds (s). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VR's Effect on Perceived Pain Intensity | Duration of ice bath (approximately 0 - 4 minutes) | During ice bath data collection participants will be asked to report pain on a numeric rating scale from 0-10, 0 being no pain and 10 being most excruciating pain imaginable every 30 seconds during ice bath |
| Skin Conductance Response Density (SCRD) | Duration of ice bath (approximately 0 - 4 minutes) | The effects of VR on modulating sympathetic response in the presence of painful stimuli, was assessed by analyzing SCRD per 30 second interval. We refer to each of these 30 second intervals as a separate epoch. Skin conductance is expected to increase with increasing sympathetic nervous system activity, as sympathetic activity increases sweat secretion to increase skin conductance. |
Countries
United States
Participant flow
Pre-assignment details
185 participants signed informed consent, 156 participants were allocated to a study arm
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants placed their dominant or non-dominant hand in ice bath with or without the use of VR/AR, then crossed to place their opposite hand in ice bath using the opposite treatment or control | 153 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Treatment (4 Minutes) | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 29.10 years STANDARD_DEVIATION 9.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants |
| First hand assignment Dominant | 73 Participants |
| First hand assignment Non-Dominant | 80 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 49 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) White | 69 Participants |
| Region of Enrollment United States | 153 Participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 69 Participants |
| VR hand assignment Dominant | 83 Participants |
| VR hand assignment Non-Dominant | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 156 | 0 / 153 |
| other Total, other adverse events | 0 / 156 | 0 / 153 |
| serious Total, serious adverse events | 0 / 156 | 0 / 153 |
Outcome results
Primary
VR Effect on Pain Tolerence
Given that the cold pressor test produces an uncomfortable experience, we considered longer duration within the ice bath to represent increased pain tolerance. Measured in seconds (s).
Time frame: Duration of ice bath (approximately 0 - 4 minutes)
Population: Participants who complete the respective interventions are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ice Bath Control | VR Effect on Pain Tolerence | 135 seconds | Standard Deviation 92 |
| Ice Bath With VR/AR | VR Effect on Pain Tolerence | 158 seconds | Standard Deviation 89 |
p-value: <0.00195% CI: [0.25, 0.51]Cox mixed effects model
Secondary
Skin Conductance Response Density (SCRD)
The effects of VR on modulating sympathetic response in the presence of painful stimuli, was assessed by analyzing SCRD per 30 second interval. We refer to each of these 30 second intervals as a separate epoch. Skin conductance is expected to increase with increasing sympathetic nervous system activity, as sympathetic activity increases sweat secretion to increase skin conductance.
Time frame: Duration of ice bath (approximately 0 - 4 minutes)
Population: Participants who complete the respective interventions are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ice Bath Control | Skin Conductance Response Density (SCRD) | 0.10 microsiemens | Standard Deviation 0.069 |
| Ice Bath With VR/AR | Skin Conductance Response Density (SCRD) | 0.09 microsiemens | Standard Deviation 0.061 |
Comparison: The variables in the physiologic model were SCRD change over time and the SCRD change between groups, defined as those with and without VR.p-value: 0.04795% CI: [0.00007, 0.00368]Linear mixed effects model
Secondary
VR's Effect on Perceived Pain Intensity
During ice bath data collection participants will be asked to report pain on a numeric rating scale from 0-10, 0 being no pain and 10 being most excruciating pain imaginable every 30 seconds during ice bath
Time frame: Duration of ice bath (approximately 0 - 4 minutes)
Population: Participants who complete the respective interventions are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ice Bath Control | VR's Effect on Perceived Pain Intensity | 30 seconds | 4.9 score on a scale | Standard Deviation 2.1 |
| Ice Bath Control | VR's Effect on Perceived Pain Intensity | 150 seconds | 5.9 score on a scale | Standard Deviation 2 |
| Ice Bath Control | VR's Effect on Perceived Pain Intensity | 90 seconds | 6.2 score on a scale | Standard Deviation 2 |
| Ice Bath Control | VR's Effect on Perceived Pain Intensity | 180 seconds | 5.6 score on a scale | Standard Deviation 2.1 |
| Ice Bath Control | VR's Effect on Perceived Pain Intensity | 60 seconds | 6.0 score on a scale | Standard Deviation 1.9 |
| Ice Bath Control | VR's Effect on Perceived Pain Intensity | 210 seconds | 5.5 score on a scale | Standard Deviation 2.3 |
| Ice Bath Control | VR's Effect on Perceived Pain Intensity | 120 seconds | 6.0 score on a scale | Standard Deviation 2 |
| Ice Bath Control | VR's Effect on Perceived Pain Intensity | 240 seconds | 5.2 score on a scale | Standard Deviation 2.3 |
| Ice Bath Control | VR's Effect on Perceived Pain Intensity | 0 seconds | 2.1 score on a scale | Standard Deviation 1.3 |
| Ice Bath With VR/AR | VR's Effect on Perceived Pain Intensity | 240 seconds | 5.0 score on a scale | Standard Deviation 2.6 |
| Ice Bath With VR/AR | VR's Effect on Perceived Pain Intensity | 0 seconds | 2.0 score on a scale | Standard Deviation 1.3 |
| Ice Bath With VR/AR | VR's Effect on Perceived Pain Intensity | 30 seconds | 4.4 score on a scale | Standard Deviation 2.1 |
| Ice Bath With VR/AR | VR's Effect on Perceived Pain Intensity | 60 seconds | 5.5 score on a scale | Standard Deviation 2 |
| Ice Bath With VR/AR | VR's Effect on Perceived Pain Intensity | 90 seconds | 5.9 score on a scale | Standard Deviation 2.1 |
| Ice Bath With VR/AR | VR's Effect on Perceived Pain Intensity | 120 seconds | 5.7 score on a scale | Standard Deviation 2 |
| Ice Bath With VR/AR | VR's Effect on Perceived Pain Intensity | 150 seconds | 5.5 score on a scale | Standard Deviation 2.3 |
| Ice Bath With VR/AR | VR's Effect on Perceived Pain Intensity | 180 seconds | 5.3 score on a scale | Standard Deviation 2.4 |
| Ice Bath With VR/AR | VR's Effect on Perceived Pain Intensity | 210 seconds | 5.1 score on a scale | Standard Deviation 2.5 |
Comparison: Analysis was controlled for dominant hand treatment assignment, dominant hand order, and gender. Overall mean difference calculated from regression model.p-value: 0.295% CI: [0.32, 0.59]Linear mixed effects model