Stationary Bike Use During Ice Bath and Virtual Reality

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Other: Stationary Bike
* Other: Virtual Reality (VR) Headset
* Other: Ice Bath


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ice Bath then VR and Bike During Ice Bath (Ice Bath vs VR Bike)<br>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<br>* Stationary Bike while hand is submerged in ice bath<br>Other: Virtual Reality (VR) Headset<br>* VR headset containing gameplay<br>Other: Ice Bath<br>* Pain was elicited via a cold pressor test, which is an established method of producing controlled and repeatable painful stimuli in an experimental setting<br>|
| Active Comparator: VR with Ice Bath then Bike with VR During Ice Bath (VR vs VR Bike)<br>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<br>* Stationary Bike while hand is submerged in ice bath<br>Other: Virtual Reality (VR) Headset<br>* VR headset containing gameplay<br>Other: Ice Bath<br>* Pain was elicited via a cold pressor test, which is an established method of producing controlled and repeatable painful stimuli in an experimental setting<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ice bath, Virtual Reality, Stationary Bike