Ice Immersion Using Virtual Reality & Augmented Reality

Not Applicable

Completed

• Conditions: Pain, Neuropathic; Pain, Acute
• Interventions: Device: VR/AR; Other: Ice Bath

• Registration Number: NCT04196686
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-24
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-12
• Primary Completion: 2021-03-04
• Study Completion: 2021-03-04
• Status Verified: 2022-02
• Results First Submitted: 2022-02-28
• Results First Submitted QC: 2022-02-28
• Last Update Submitted: 2022-02-28
• Results First Posted: 2022-03-25
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• Greater than 18 years of age
• English speaking
• Hearing intact

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ice bath Control then VR/AR	Ice Bath	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.
Ice bath Control then VR/AR	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.
Ice bath with VR/AR then Control	Ice Bath	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.
Ice bath with VR/AR then Control	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States