Stationary Bike Use During Ice Bath and Virtual Reality

Pain Clinical Trial

Official title:

The Utilization of a Stationary Bike During Ice Bath While Using Virtual Reality (VR) to Determine Overall Pain Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05297838
• Other study ID #: 64860
• Status: Completed
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: January 26, 2023

Study information

• Verified date: August 2023
• 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, in particular Virtual Reality, inclusive of 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 while utilizing a stationary bike.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 26, 2023
• Est. primary completion date: January 26, 2023
• 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

• Are 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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Stationary Bike
Stationary Bike while hand is submerged in ice bath
• Virtual Reality (VR) Headset
VR headset containing gameplay
• Ice Bath
Pain was elicited via a cold pressor test, which is an established method of producing controlled and repeatable painful stimuli in an experimental setting

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	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	Self-Reported Pain Scores (Ice Bath vs VR Bike)	Pain Scores will be collected during ice bath (maximum of 4 minutes) every 30 seconds via numeric rating scale (NRS), 0 being no pain, 10 being worst pain imaginable	Duration of ice bath (approximately 0 - 4 minutes)
Primary	Sympathetic Activation (VR vs VR Bike)	Assessed via the electrodermal activity (EDA biosensor), which recorded skin conductance response density (SCRD) data in 30 second epochs. SCRD was recorded for the duration of the cold pressor test and one minute before and after submersion. The same primary and secondary outcome measures were collected at identical time points during the different cold pressor challenges on each hand	Duration of ice bath (approximately 0 - 4 minutes)
Secondary	Pain Tolerance (Ice Bath vs VR Bike)	Defined by time of hand removal from the ice bath in seconds. 4 minute maximum.	Duration of ice bath (approximately 0 - 4 minutes)
Secondary	Sympathetic Activation (Ice Bath vs VR Bike)	Assessed via the electrodermal activity (EDA biosensor), which recorded skin conductance response density (SCRD) data in 30 second epochs. SCRD was recorded for the duration of the cold pressor test and one minute before and after submersion. The same primary and secondary outcome measures were collected at identical time points during the different cold pressor challenges on each hand.	Duration of ice bath (approximately 0 - 4 minutes)
Secondary	Self-Reported Pain Scores (VR vs VR Bike)	Pain Scores will be collected during ice bath (maximum of 4 minutes) every 30 seconds via numeric rating scale (NRS), 0 being no pain, 10 being worst pain imaginable and immediately after participant removed their hand from ice bath.	Duration of ice bath (approximately 0 - 4 minutes)
Secondary	Pain Tolerance (VR vs VR Bike)	Defined by time of hand removal from the ice bath in seconds. 4 minute maximum. The same outcome measure were collected at identical timepoints during both conditions.	Duration of ice bath (approximately 0 - 4 minutes)