Back to resultsIce Immersion Using Virtual Reality & Augmented Reality
Primary Purpose
Pain, Neuropathic, Pain, Acute
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR/AR
Ice Bath
Sponsored by
About this trial
This is an interventional other trial for Pain, Neuropathic focused on measuring Virtual Reality, Augmented Reality, Ice Immersion
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ice bath Control then VR/AR
Ice bath with VR/AR then Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT04196686
First Posted
November 19, 2019
Last Updated
February 28, 2022
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT04196686
Brief Title
Ice Immersion Using Virtual Reality & Augmented Reality
Official Title
Evaluating the Effectiveness of Immersive Technologies, Virtual Reality and Augmented Reality, to Increase Pain Threshold During Ice Immersion.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
March 4, 2021 (Actual)
Study Completion Date
March 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic, Pain, Acute
Keywords
Virtual Reality, Augmented Reality, Ice Immersion
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ice bath Control then VR/AR
Arm Type
Experimental
Arm Description
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.
Arm Title
Ice bath with VR/AR then Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VR/AR
Intervention Description
VR/AR headset with either passive or active content such as playing a game or watching a movie
Intervention Type
Other
Intervention Name(s)
Ice Bath
Intervention Description
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.
Primary Outcome Measure Information:
Title
VR Effect on Pain Tolerence
Description
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)
Secondary Outcome Measure Information:
Title
VR's Effect on Perceived Pain Intensity
Description
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)
Title
Skin Conductance Response Density (SCRD)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ice Immersion Using Virtual Reality & Augmented Reality
We'll reach out to this number within 24 hrs