Ice Immersion Using Virtual Reality & Augmented Reality

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196686
• Other study ID #: 50951
• Status: Completed
• Phase: N/A
• Start date: July 24, 2019
• Est. completion date: March 4, 2021

Study information

• Verified date: February 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: March 4, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Neuralgia
• Pain, Acute
• Pain, Neuropathic

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)