PainNCT03268863
Evaluating VR Therapy Using Cold Pressor Test
A study testing Virtual Reality and Cold Pressor in people with Pain, run by Janet Vittone at 2 sites in United States.
Trial summary
This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile phones can be used as a potential distractor from pain and thus would have clinical applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients undergoing painful or uncomfortable procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Virtual Reality and Cold Pressor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2017to 20 Jul 2018
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult Mayo Clinic students and employees
Who cannot join
- Participants who are known to be sensitive to VR technology and/or have undesirable reactions to VR technology (i.e. dizziness, motion sickness)
- Participants with significant alcohol/smoking histories, sickle cell anemia, history of previous myocardial infarction and/or coronary artery disease, malignant hypertension, metabolic
- dysfunctions, pregnancy, Raynaud's disease, epilepsy, severe mental disorders, chronic pain conditions, or diseases producing neuropathic pain
- Participants that have used drugs/alcohol the day prior to the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55901
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Using the Cold Pressor Test to Assess Effectiveness of Low-Cost, Immersive Virtual Reality Therapy
This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile phones can be used as a potential distractor from pain and thus would have clinical applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients undergoing painful or uncomfortable procedures. To do this, the investigators are asking volunteers to submerge their hand up to the wrist in cold water (Cold Pressor Test), either while playing an interactive virtual reality game on the headset, or while wearing a VR headset that is turned off as a control. The investigators will record the participants' tolerance to cold water as measured by how long the participants are able to keep their hand in the cold water.
- Conditions
- Pain
- Being tested
- Virtual Reality, Cold Pressor
- Keywords
- pain tolerance, perioperative pain, virtual reality therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Google Cardboard virtual reality headset
Cold PressorOther
Also called Cold Pressor Test
A cold ice water bath for use in pain/discomfort simulation
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Google Cardboard Virtual Reality headset running an interactive game Receives: Device: Virtual Reality; Other: Cold Pressor |
| Control | Sham comparator | Powered down Google Cardboard Virtual Reality headset Receives: Other: Cold Pressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Tolerance
Likert Scale, 0-10
Measured: 10 minutes
Secondary outcomes (3)
Pain threshold
Onset of pain/discomfort as expressed verbally, in seconds and minutes
Measured: 10 minutes
maximal pain
Likert scale
Measured: 10 minutes
Nausea
modified Likert scale
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start10 Sep 2017
- Primary completion10 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janet Vittone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Janet Vittone, Mayo Clinic
- Investigators
- Janet Vittone, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268863
- Sponsor's protocol ID
- 17-004181
- Status last verified
- Jun 2019
- First submitted
- 28 Jul 2017
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Cold Pressor Test to Assess Effectiveness of Low-Cost, Immersive Virtual Reality Therapy
- ClinicalTrials.gov ID
- NCT03268863
- Acronym / sponsor ID
- 17-004181
- Conditions
- Pain
- Keywords
- pain tolerance, perioperative pain, virtual reality therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Janet VittoneUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 31 Aug 2017 (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.
This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile phones can be used as a potential distractor from pain and thus would have clinical applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients undergoing painful or uncomfortable procedures. To do this, the investigators are asking volunteers to submerge their hand up to the wrist in cold water (Cold Pressor Test), either while playing an interactive virtual reality game on the headset, or while wearing a VR headset that is turned off as a control. The investigators will record the participants' tolerance to cold water as measured by how long the participants are able to keep their hand in the cold water.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual Reality, Other: Cold PressorGoogle Cardboard Virtual Reality headset running an interactive game |
| Control | Sham comparator | Other: Cold PressorPowered down Google Cardboard Virtual Reality headset |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult Mayo Clinic students and employees
Key exclusion criteria (4 listed)
- Participants who are known to be sensitive to VR technology and/or have undesirable reactions to VR technology (i.e. dizziness, motion sickness)
- Participants with significant alcohol/smoking histories, sickle cell anemia, history of previous myocardial infarction and/or coronary artery disease, malignant hypertension, metabolic
- dysfunctions, pregnancy, Raynaud's disease, epilepsy, severe mental disorders, chronic pain conditions, or diseases producing neuropathic pain
- Participants that have used drugs/alcohol the day prior to the study
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 |
|---|---|---|
| Virtual RealityGoogle Cardboard virtual reality headset | Device | Virtual Reality |
| Cold PressorAlso: Cold Pressor TestA cold ice water bath for use in pain/discomfort simulation | Other | Control, Virtual Reality |
Primary outcome
Pain Tolerance
Time frame: 10 minutes
Likert Scale, 0-10
3 secondary outcomes
Pain threshold
Time frame: 10 minutes
maximal pain
Time frame: 10 minutes
Nausea
Time frame: 10 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 11 Jun 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Janet Vittone principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Cold Pressor in people with Pain, run by Janet Vittone at 2 sites 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 1 inclusion and 4 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Pain Tolerance (time frame: 10 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 11 Jun 2019.