Ice Immersion Using Virtual Reality & Augmented Reality

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04196686
• Collaborator: (none)
• Enrollment: 185
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.4
• Patients Per Site Per Month: 9.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Neuropathic; Pain, Acute	Device: VR/AR; Other: Ice Bath	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 185 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluating the Effectiveness of Immersive Technologies, Virtual Reality and Augmented Reality, to Increase Pain Threshold During Ice Immersion.
• Actual Study Start Date: Jul 24, 2019
• Actual Primary Completion Date: Mar 4, 2021
• Actual Study Completion Date: Mar 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ice bath Control then VR/AR 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; VR/AR headset with either passive or active content such as playing a game or watching a movie; Other: Ice 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.
Experimental: Ice bath with VR/AR then Control 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; VR/AR headset with either passive or active content such as playing a game or watching a movie; Other: Ice 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 10, 2020
• Statistical Analysis Plan - Feb 23, 2022

More Information

Publications

None provided.

• Responsible Party: Samuel Rodriguez, Clinical Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT04196686
• Other Study ID Numbers: 50951
• First Posted: Dec 12, 2019
• Last Update Posted: Mar 25, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Samuel Rodriguez, Clinical Associate Professor, Stanford University: Virtual Reality; Augmented Reality; Ice Immersion
• Additional relevant MeSH terms: Neuralgia; Acute Pain

Study Results

Participant Flow

Pre-assignment Detail	185 participants signed informed consent, 156 participants were allocated to a study arm

Arm/Group Title	Ice Bath Control Then VR/AR	Ice Bath With VR/AR Then Control
Arm/Group Description	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	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
Period Title: First Treatment (4 Minutes)
STARTED	78	78
COMPLETED	78	75
NOT COMPLETED	0	3
Period Title: First Treatment (4 Minutes)
STARTED	78	75
COMPLETED	78	75
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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
Overall Participants	153
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.10 (9.83)
Sex: Female, Male (Count of Participants)
Female	84 54.9%
Male	69 45.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	26 17%
Not Hispanic or Latino	108 70.6%
Unknown or Not Reported	19 12.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.7%
Asian	49 32%
Native Hawaiian or Other Pacific Islander	1 0.7%
Black or African American	2 1.3%
White	69 45.1%
More than one race	12 7.8%
Unknown or Not Reported	19 12.4%
Region of Enrollment (Count of Participants)
United States	153 100%
First hand assignment (Count of Participants)
Dominant	73 47.7%
Non-Dominant	80 52.3%
VR hand assignment (Count of Participants)
Dominant	83 54.2%
Non-Dominant	70 45.8%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Participants who complete the respective interventions are included in the analysis.

Arm/Group Title	Ice Bath Control	Ice Bath With VR/AR
Arm/Group Description	Participants placed their dominant or non-dominant hand in ice bath without the use of VR/AR	Participants placed their dominant or non-dominant hand in ice bath with the use of VR/AR
Measure Participants	156	153
Mean (Standard Deviation) [seconds]	135 (92)	158 (89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ice Bath Control, Ice Bath With VR/AR
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cox mixed effects model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.36
	Confidence Interval	(2-Sided) 95%; 0.25 to 0.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

Participants who complete the respective interventions are included in the analysis.

Arm/Group Title	Ice Bath Control	Ice Bath With VR/AR
Arm/Group Description	Participants placed their dominant or non-dominant hand in ice bath without the use of VR/AR	Participants placed their dominant or non-dominant hand in ice bath with the use of VR/AR
Measure Participants	156	153
0 seconds	2.1 (1.3)	2.0 (1.3)
30 seconds	4.9 (2.1)	4.4 (2.1)
60 seconds	6.0 (1.9)	5.5 (2.0)
90 seconds	6.2 (2.0)	5.9 (2.1)
120 seconds	6.0 (2.0)	5.7 (2.0)
150 seconds	5.9 (2.0)	5.5 (2.3)
180 seconds	5.6 (2.1)	5.3 (2.4)
210 seconds	5.5 (2.3)	5.1 (2.5)
240 seconds	5.2 (2.3)	5.0 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ice Bath Control, Ice Bath With VR/AR
	Comments	Analysis was controlled for dominant hand treatment assignment, dominant hand order, and gender. Overall mean difference calculated from regression model.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.200
	Comments
	Method	Linear mixed effects model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.455
	Confidence Interval	(2-Sided) 95%; 0.32 to 0.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

Participants who complete the respective interventions are included in the analysis.

Arm/Group Title	Ice Bath Control	Ice Bath With VR/AR
Arm/Group Description	Participants placed their dominant or non-dominant hand in ice bath without the use of VR/AR	Participants placed their dominant or non-dominant hand in ice bath with the use of VR/AR
Measure Participants	156	153
Mean (Standard Deviation) [microsiemens]	0.10 (0.069)	0.09 (0.061)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ice Bath Control, Ice Bath With VR/AR
	Comments	The variables in the physiologic model were SCRD change over time and the SCRD change between groups, defined as those with and without VR.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.047
	Comments
	Method	Linear mixed effects model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.002
	Confidence Interval	(2-Sided) 95%; 0.00007 to 0.00368
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	1 day
Arm/Group Title	Ice Bath Control		Ice Bath With VR/AR
Arm/Group Description	Participants placed their dominant or non-dominant hand in ice bath without the use of VR/AR		Participants placed their dominant or non-dominant hand in ice bath with the use of VR/AR
All Cause Mortality
	Ice Bath Control		Ice Bath With VR/AR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/153 (0%)
Serious Adverse Events
	Ice Bath Control		Ice Bath With VR/AR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/153 (0%)
Other (Not Including Serious) Adverse Events
	Ice Bath Control		Ice Bath With VR/AR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/153 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.