Ice Immersion Using Virtual Reality & Augmented Reality
Evaluating the Effectiveness of Immersive Technologies, Virtual Reality and Augmented Reality, to Increase Pain Threshold During Ice Immersion.
1 other identifier
interventional
185
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2019
CompletedFirst Submitted
Initial submission to the registry
November 19, 2019
CompletedFirst Posted
Study publicly available on registry
December 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2021
CompletedResults Posted
Study results publicly available
March 25, 2022
CompletedMarch 25, 2022
February 1, 2022
1.6 years
November 19, 2019
February 28, 2022
February 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (2)
VR's Effect on Perceived Pain Intensity
Duration of ice bath (approximately 0 - 4 minutes)
Skin Conductance Response Density (SCRD)
Duration of ice bath (approximately 0 - 4 minutes)
Study Arms (2)
Ice bath Control then VR/AR
EXPERIMENTALParticipants 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.
Ice bath with VR/AR then Control
EXPERIMENTALParticipants 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.
Interventions
VR/AR headset with either passive or active content such as playing a game or watching a movie
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.
Eligibility Criteria
You may qualify if:
- Greater than 18 years of age
- English speaking
- Hearing intact
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Samuel Rodriguez, MD
- Organization
- Lucile Packard Children's Hospital Stanford
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
November 19, 2019
First Posted
December 12, 2019
Study Start
July 24, 2019
Primary Completion
March 4, 2021
Study Completion
March 4, 2021
Last Updated
March 25, 2022
Results First Posted
March 25, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share