Ice Immersion Using Virtual Reality & Augmented Reality

NCT ID: NCT04196686

Last Updated: 2022-03-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-24

Study Completion Date

2021-03-04

Brief Summary

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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

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Conditions

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Pain, Neuropathic Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

VR/AR

Intervention Type DEVICE

VR/AR headset with either passive or active content such as playing a game or watching a movie

Ice Bath

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

VR/AR

Intervention Type DEVICE

VR/AR headset with either passive or active content such as playing a game or watching a movie

Ice Bath

Intervention Type OTHER

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.

Interventions

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VR/AR

VR/AR headset with either passive or active content such as playing a game or watching a movie

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Samuel Rodriguez

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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50951

Identifier Type: -

Identifier Source: org_study_id

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