Stationary Bike Use During Ice Bath and Virtual Reality

NCT05297838 | Completed

• 1 other identifier: 64860
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Ice bath; Virtual Reality; Stationary Bike

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Pain Tolerance (Ice Bath vs VR Bike)

  Duration of ice bath (approximately 0 - 4 minutes)

• Sympathetic Activation (Ice Bath vs VR Bike)

  Duration of ice bath (approximately 0 - 4 minutes)

• Self-Reported Pain Scores (VR vs VR Bike)

  Duration of ice bath (approximately 0 - 4 minutes)

• Pain Tolerance (VR vs VR Bike)

  Duration of ice bath (approximately 0 - 4 minutes)

Study Arms (2)

Ice Bath then VR and Bike During Ice Bath (Ice Bath vs VR Bike)

ACTIVE COMPARATOR

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; Other: Virtual Reality (VR) Headset; Other: Ice Bath

VR with Ice Bath then Bike with VR During Ice Bath (VR vs VR Bike)

ACTIVE COMPARATOR

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; Other: Virtual Reality (VR) Headset; Other: Ice Bath

Interventions

Stationary Bike OTHER

Stationary Bike while hand is submerged in ice bath

Ice Bath then VR and Bike During Ice Bath (Ice Bath vs VR Bike); VR with Ice Bath then Bike with VR During Ice Bath (VR vs VR Bike)

Virtual Reality (VR) Headset OTHER

VR headset containing gameplay

Ice Bath then VR and Bike During Ice Bath (Ice Bath vs VR Bike); VR with Ice Bath then Bike with VR During Ice Bath (VR vs VR Bike)

Ice Bath OTHER

Pain was elicited via a cold pressor test, which is an established method of producing controlled and repeatable painful stimuli in an experimental setting

Ice Bath then VR and Bike During Ice Bath (Ice Bath vs VR Bike); VR with Ice Bath then Bike with VR During Ice Bath (VR vs VR Bike)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: July 25, 2022
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)