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.

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Pain, Neuropathic
• Intervention / Treatment: Device: VR/AR; Other: Ice Bath

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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)

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 24, 2019
• Primary Completion (ACTUAL): March 4, 2021
• Study Completion (ACTUAL): March 4, 2021

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (ACTUAL): December 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Virtual Reality; Augmented Reality; Ice Immersion
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Acute Pain
• Other Study ID Numbers: 50951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes