Stationary Bike Use During Ice Bath and Virtual Reality

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Stationary Bike; Other: Virtual Reality (VR) Headset; Other: Ice Bath

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ice Bath then VR and Bike During Ice Bath (Ice Bath vs VR Bike); Participants will immerse hand in ice bath and keep hand submerged as long as they can withstand the cold or until 4 minutes have elapsed, whichever comes first, while utilizing a VR headset. 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. After a washout period of 5 minutes, patients will immerse hand in ice bath keep hand submerged as long as they can withstand the cold or until 4 minutes have elapsed, whichever comes first, while utilizing a VR headset.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. This occurred for both dominant and non-dominant hand. Randomization of dominant and non-dominant hands to the study conditions occurred prior to initiating the intervention.	Other: Stationary Bike; Stationary Bike while hand is submerged in ice bath; Other: Virtual Reality (VR) Headset; VR headset containing gameplay; Other: 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
Active Comparator: VR with Ice Bath then Bike with VR During Ice Bath (VR vs VR Bike); Patients will immerse hand in ice bath keep hand submerged as long as they can withstand the cold or until 4 minutes have elapsed, whichever comes first, while utilizing a VR headset.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. After a washout period of 5 minutes, Participants will immerse hand in ice bath while utilizing stationary bike and keep hand submerged as long as they can withstand the cold or until 4 minutes have elapsed, whichever comes first, while utilizing a VR headset. 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. This occurred for both dominant and non-dominant hand. Randomization of dominant and non-dominant hands to the study conditions occurred prior to initiating the intervention.	Other: Stationary Bike; Stationary Bike while hand is submerged in ice bath; Other: Virtual Reality (VR) Headset; VR headset containing gameplay; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): January 26, 2023
• Study Completion (Actual): January 26, 2023

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Virtual Reality; Ice bath; Stationary Bike
• Other Study ID Numbers: 64860

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: No
• product manufactured in and exported from the U.S.: No