Ice Immersion Using Virtual Reality & Augmented Reality

Study Overview
=================
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.

Official Title
-----------------
Evaluating the Effectiveness of Immersive Technologies, Virtual Reality and Augmented Reality, to Increase Pain Threshold During Ice Immersion.

Conditions
-----------------
Pain, Neuropathic, Pain, Acute

Intervention / Treatment
-----------------
* Device: VR/AR
* Other: Ice Bath


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ice bath Control then VR/AR<br>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. | Device: VR/AR<br>* VR/AR headset with either passive or active content such as playing a game or watching a movie<br>Other: Ice Bath<br>* 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.<br>|
| Experimental: Ice bath with VR/AR then Control<br>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. | Device: VR/AR<br>* VR/AR headset with either passive or active content such as playing a game or watching a movie<br>Other: Ice Bath<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality, Augmented Reality, Ice Immersion