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OpenTrials
Completed

NCT Number: NCT05297838

Stationary Bike Use During Ice Bath and Virtual Reality

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stationary Bike

Other

Stationary Bike while hand is submerged in ice bath

Virtual Reality (VR) Headset

Other

VR headset containing gameplay

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

Primary outcomes

  1. Self-Reported Pain Scores (Ice Bath vs VR Bike)

    Time frame: 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

  2. Sympathetic Activation (VR vs VR Bike)

    Time frame: 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

Secondary outcomes

  1. Pain Tolerance (Ice Bath vs VR Bike)

    Time frame: Duration of ice bath (approximately 0 - 4 minutes)

    Defined by time of hand removal from the ice bath in seconds. 4 minute maximum.

  2. Sympathetic Activation (Ice Bath vs VR Bike)

    Time frame: 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.

  3. Self-Reported Pain Scores (VR vs VR Bike)

    Time frame: 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.

  4. Pain Tolerance (VR vs VR Bike)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2022
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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