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OpenTrials
Completed

NCT Number: NCT04196686

Ice Immersion Using Virtual Reality & Augmented Reality

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.

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Key information

Conditions

Pain, Neuropathic Acute Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain, Acute Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR/AR

Device

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

Ice Bath

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.

Primary outcomes

  1. VR Effect on Pain Tolerence

    Time frame: 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 outcomes

  1. VR's Effect on Perceived Pain Intensity

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 12, 2019
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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