Pain, NeuropathicNCT04196686
Ice Immersion Using Virtual Reality & Augmented Reality
A study testing VR/AR and Ice Bath in people with Pain, Neuropathic and Pain, Acute, 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, Virtual Reality and Augmented Reality with modifications as 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Neuropathic, Pain, Acute
- What is being tested?
- VR/AR and Ice Bath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2019to 4 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
- Have taken pain medications in the last 12 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of Immersive Technologies, Virtual Reality and Augmented Reality, to Increase Pain Threshold During Ice Immersion.
The purpose of this study is to evaluate the effectiveness of different technologies, Virtual Reality and Augmented Reality with modifications as 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.
- Conditions
- Pain, Neuropathic, Pain, Acute
- Being tested
- VR/AR, Ice Bath
- Keywords
- Virtual Reality, Augmented Reality, Ice Immersion
- Medical subject headings
- Neuralgia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR/ARDevice
VR/AR headset with either passive or active content such as playing a game or watching a movie
Ice BathOther
Participants immerse hand in ice bath and starting again with their original assigned group and keep hand submerged as long as they can withstand the cold or until 4 minutes have elapsed, whichever comes first. 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.
| Study group | Role | What they receive |
|---|---|---|
| Ice bath Control then VR/AR | Experimental | Participants will be randomized with a 1:1 allocation to use their dominant or non-dominant hand with VR or control (no VR) for the cold pressor test and then crossed over. 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. Receives: Device: VR/AR; Other: Ice Bath |
| Ice bath with VR/AR then Control | Experimental | Participants will be randomized with a 1:1 allocation to use their dominant or non-dominant hand with VR or control (no VR) for the cold pressor test and then crossed over. 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. Receives: Device: VR/AR; Other: Ice Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
VR Effect on Pain Tolerence
Given that the cold pressor test produces an uncomfortable experience, we considered longer duration within the ice bath to represent increased pain tolerance. Measured in seconds (s).
Measured: Duration of ice bath (approximately 0 - 4 minutes)
Secondary outcomes (2)
VR's Effect on Perceived Pain Intensity
During ice bath data collection participants will be asked to report pain on a numeric rating scale from 0-10, 0 being no pain and 10 being most excruciating pain imaginable every 30 seconds during ice bath
Measured: Duration of ice bath (approximately 0 - 4 minutes)
Skin Conductance Response Density (SCRD)
The effects of VR on modulating sympathetic response in the presence of painful stimuli, was assessed by analyzing SCRD per 30 second interval. We refer to each of these 30 second intervals as a separate epoch. Skin conductance is expected to increase with increasing sympathetic nervous system activity, as sympathetic activity increases sweat secretion to increase skin conductance.
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 posted12 Dec 2019
- Study start24 Jul 2019
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, NeuropathicStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 185 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
- NCT04196686
- Sponsor's protocol ID
- 50951
- Status last verified
- Feb 2022
- First submitted
- 19 Nov 2019
- Last updated
- 25 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Immersive Technologies, Virtual Reality and Augmented Reality, to Increase Pain Threshold During Ice Immersion.
- ClinicalTrials.gov ID
- NCT04196686
- Acronym / sponsor ID
- 50951
- Conditions
- Pain, Neuropathic, Pain, Acute
- Keywords
- Virtual Reality, Augmented Reality, Ice Immersion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Posted 25 Mar 2022
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, Virtual Reality and Augmented Reality with modifications as 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice bath Control then VR/AR | Experimental | Device: VR/AR, Other: Ice BathParticipants will be randomized with a 1:1 allocation to use their dominant or non-dominant hand with VR or control (no VR) for the cold pressor test and then crossed over. 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. |
| Ice bath with VR/AR then Control | Experimental | Device: VR/AR, Other: Ice BathParticipants will be randomized with a 1:1 allocation to use their dominant or non-dominant hand with VR or control (no VR) for the cold pressor test and then crossed over. 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. |
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 (7 listed)
- Patients who do not consent
- 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 |
|---|---|---|
| VR/ARVR/AR headset with either passive or active content such as playing a game or watching a movie | Device | Ice bath Control then VR/AR, Ice bath with VR/AR then Control |
| Ice BathParticipants immerse hand in ice bath and starting again with their original assigned group and keep hand submerged as long as they can withstand the cold or until 4 minutes have elapsed, whichever comes first. 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. | Other | Ice bath Control then VR/AR, Ice bath with VR/AR then Control |
Primary outcome
VR Effect on Pain Tolerence
Time frame: Duration of ice bath (approximately 0 - 4 minutes)
Given that the cold pressor test produces an uncomfortable experience, we considered longer duration within the ice bath to represent increased pain tolerance. Measured in seconds (s).
2 secondary outcomes
VR's Effect on Perceived Pain Intensity
Time frame: Duration of ice bath (approximately 0 - 4 minutes)
Skin Conductance Response Density (SCRD)
Time frame: Duration of ice bath (approximately 0 - 4 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pain, Neuropathic
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingPhase 1/2
RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia
Trigeminal Neuralgia
RecruitingPhase 2
Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN
Trigeminal Neuralgia (TN)
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
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 VR/AR and Ice Bath in people with Pain, Neuropathic and Pain, Acute, 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 7 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 25 Mar 2022. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
VR Effect on Pain Tolerence (time frame: Duration of ice bath (approximately 0 - 4 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2022.