PainNCT05297838
Stationary Bike Use During Ice Bath and Virtual Reality
A study testing Stationary Bike, Virtual Reality (VR) Headset and Ice Bath in people with Pain, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Stationary Bike, Virtual Reality (VR) Headset and Ice Bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 26 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Greater than 18 years of age
- English speaking
- Hearing intact
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
About this study
Official title: 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.
- Conditions
- Pain
- Being tested
- Stationary Bike, Virtual Reality (VR) Headset, Ice Bath
- Keywords
- Ice bath, Virtual Reality, Stationary Bike
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stationary BikeOther
Stationary Bike while hand is submerged in ice bath
Virtual Reality (VR) HeadsetOther
VR headset containing gameplay
Ice BathOther
Pain was elicited via a cold pressor test, which is an established method of producing controlled and repeatable painful stimuli in an experimental setting
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Stationary Bike; Other: Virtual Reality (VR) Headset; Other: Ice Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Duration of ice bath (approximately 0 - 4 minutes)
Secondary outcomes (4)
Pain Tolerance (Ice Bath vs VR Bike)
Defined by time of hand removal from the ice bath in seconds. 4 minute maximum.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Duration of ice bath (approximately 0 - 4 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start25 Jul 2022
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Rodriguez, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297838
- Sponsor's protocol ID
- 64860
- Status last verified
- Aug 2023
- First submitted
- 17 Mar 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez ST, Makarewicz N, Wang EY, Zuniga-Hernandez M, Titzler J, Jackson C, Suen MY, Rosales O, Caruso TJ. Virtual Reality Facilitated Exercise Increases Sympathetic Activity and Reduces Pain Perception: A Randomized Crossover Study. Am J Phys Med Rehabil. 2024 Jan 1;104(1):51-57. doi: 10.1097/PHM.0000000000002550. Epub 2024 Jun 6.
PubMed 38842101
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of a Stationary Bike During Ice Bath While Using Virtual Reality (VR) to Determine Overall Pain Reduction
- ClinicalTrials.gov ID
- NCT05297838
- Acronym / sponsor ID
- 64860
- Conditions
- Pain
- Keywords
- Ice bath, Virtual Reality, Stationary Bike
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice Bath then VR and Bike During Ice Bath (Ice Bath vs VR Bike) | Active comparator | Other: Stationary Bike, Other: Virtual Reality (VR) Headset, Other: Ice BathParticipants 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) | Active comparator | Other: Stationary Bike, Other: Virtual Reality (VR) Headset, Other: Ice BathPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 18 years of age
- English speaking
- Hearing intact
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stationary BikeStationary Bike while hand is submerged in ice bath | Other | 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) HeadsetVR headset containing gameplay | Other | 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 BathPain was elicited via a cold pressor test, which is an established method of producing controlled and repeatable painful stimuli in an experimental setting | Other | 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) |
Primary outcome
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
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
4 secondary outcomes
Pain Tolerance (Ice Bath vs VR Bike)
Time frame: Duration of ice bath (approximately 0 - 4 minutes)
Sympathetic Activation (Ice Bath vs VR Bike)
Time frame: Duration of ice bath (approximately 0 - 4 minutes)
Self-Reported Pain Scores (VR vs VR Bike)
Time frame: Duration of ice bath (approximately 0 - 4 minutes)
Pain Tolerance (VR vs VR Bike)
Time frame: Duration of ice bath (approximately 0 - 4 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 38842101Rodriguez ST, Makarewicz N, Wang EY, Zuniga-Hernandez M, Titzler J, Jackson C, Suen MY, Rosales O, Caruso TJ. Virtual Reality Facilitated Exercise Increases Sympathetic Activity and Reduces Pain Perception: A Randomized Crossover Study. Am J Phys Med Rehabil. 2024 Jan 1;104(1):51-57. doi: 10.1097/PHM.0000000000002550. Epub 2024 Jun 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stationary Bike, Virtual Reality (VR) Headset and Ice Bath in people with Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Pain Scores (Ice Bath vs VR Bike) (time frame: Duration of ice bath (approximately 0 - 4 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05297838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.