Stationary Bike Use During Ice Bath and Virtual Reality

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Stationary Bike; Other: Virtual Reality (VR) Headset; Other: Ice Bath

• Registration Number: NCT05297838
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Study Start: 2022-07-25
• Primary Completion: 2023-01-26
• Study Completion: 2023-01-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Greater than 18 years of age
• English speaking
• Hearing intact

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ice Bath then VR and Bike During Ice Bath (Ice Bath vs VR Bike)	Stationary 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.
Ice Bath then VR and Bike During Ice Bath (Ice Bath vs VR Bike)	Ice Bath	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.
VR with Ice Bath then Bike with VR During Ice Bath (VR vs VR Bike)	Ice Bath	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.
VR with Ice Bath then Bike with VR During Ice Bath (VR vs VR Bike)	Stationary 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.
Ice Bath then VR and Bike During Ice Bath (Ice Bath vs VR Bike)	Virtual Reality (VR) Headset	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.
VR with Ice Bath then Bike with VR During Ice Bath (VR vs VR Bike)	Virtual Reality (VR) Headset	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.

Primary Outcome Measures

Name	Time	Method
Sympathetic Activation (VR vs VR Bike)	Duration of ice bath (approximately 0 - 4 minutes)	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
Self-Reported Pain Scores (Ice Bath vs VR Bike)	Duration of ice bath (approximately 0 - 4 minutes)	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

Secondary Outcome Measures

Name	Time	Method
Pain Tolerance (VR vs VR Bike)	Duration of ice bath (approximately 0 - 4 minutes)	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.
Sympathetic Activation (Ice Bath vs VR Bike)	Duration of ice bath (approximately 0 - 4 minutes)	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.
Self-Reported Pain Scores (VR vs VR Bike)	Duration of ice bath (approximately 0 - 4 minutes)	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.
Pain Tolerance (Ice Bath vs VR Bike)	Duration of ice bath (approximately 0 - 4 minutes)	Defined by time of hand removal from the ice bath in seconds. 4 minute maximum.

Trial Locations

Locations (1)

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States