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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ice bath Control then VR/AR | Experimental | Participants will be randomized with a 1:1 allocation to use their dominant or non-dominant hand with VR or control (no VR) for the cold pressor test and then crossed over. 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. |
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| Ice bath with VR/AR then Control | Experimental | Participants will be randomized with a 1:1 allocation to use their dominant or non-dominant hand with VR or control (no VR) for the cold pressor test and then crossed over. 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR/AR | Device | VR/AR headset with either passive or active content such as playing a game or watching a movie |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Duration of ice bath (approximately 0 - 4 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Duration of ice bath (approximately 0 - 4 minutes) |
| Skin Conductance Response Density (SCRD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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185 participants signed informed consent, 156 participants were allocated to a study arm
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| ID | Title | Description |
|---|---|---|
| FG000 | Ice Bath Control Then VR/AR | Participants placed their dominant or non-dominant hand in ice bath without the use of Virtual Reality (VR)/Augmented Reality (AR), then crossed to place their opposite hand in ice bath with the use of VR/AR |
| FG001 | Ice Bath With VR/AR Then Control | Participants placed their dominant or non-dominant hand in ice bath with the use of Virtual Reality (VR)/Augmented Reality (AR), then crossed to place their opposite hand in ice bath without the use of VR/AR |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment (4 Minutes) |
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| Second Treatment (4 Minutes) |
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Participants who completed the protocol are included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Participants who complete the respective interventions are included in the analysis. | Posted | Mean | Standard Deviation | seconds | Duration of ice bath (approximately 0 - 4 minutes) |
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1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ice Bath Control | Participants placed their dominant or non-dominant hand in ice bath without the use of VR/AR |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samuel Rodriguez, MD | Lucile Packard Children's Hospital Stanford | (650)723-6412 | sr1@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2020 | Feb 11, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2022 | Feb 23, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| Ice Bath | Other | 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. |
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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. |
| Duration of ice bath (approximately 0 - 4 minutes) |
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| First hand assignment | Count of Participants | Participants |
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| VR hand assignment | Count of Participants | Participants |
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| 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 | Participants who complete the respective interventions are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Duration of ice bath (approximately 0 - 4 minutes) |
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| 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. | Participants who complete the respective interventions are included in the analysis. | Posted | Mean | Standard Deviation | microsiemens | Duration of ice bath (approximately 0 - 4 minutes) |
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| 0 |
| 156 |
| 0 |
| 156 |
| 0 |
| 156 |
| EG001 | Ice Bath With VR/AR | Participants placed their dominant or non-dominant hand in ice bath with the use of VR/AR | 0 | 153 | 0 | 153 | 0 | 153 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 60 seconds |
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| 90 seconds |
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| 120 seconds |
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| 150 seconds |
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| 180 seconds |
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| 210 seconds |
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| 240 seconds |
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