Pain, AcuteNCT04245475
Water-friendly Virtual Reality and Brief Thermal Pain
A study testing Virtual Reality psychological pain reduction in people with Pain, Acute, run by University of Washington at 1 site in United States.
Trial summary
Using immersive virtual reality as a form of pain distraction during a brief "painful but tolerable" temperature. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Virtual Reality psychological pain reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 30 Apr 2021
- 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
- Currently enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
- Able to read, write and comprehend English
- Able to complete study measures
- Willing to follow our UW approved instructions
- 18 years of age or older
Who cannot join
- People how have already previously participated in this same study (e.g., last quarter) are not eligible to participate again.
- Not enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
- Not be able to read, write and comprehend English
- Younger than 18 years of age.
- Not capable of completing measures
- Not capable of indicating pain intensity,
Show all 14Show fewer
- Not capable of filling out study measures,
- Extreme susceptibility to motion sickness,
- Seizure history,
- Unusual sensitivity or lack of sensitivity to pain,
- Sensitive skin,
- sensitive feet,
- migraines,
- Diabetes.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington (public not eligible for participation)
Seattle, Washington, 98195
About this study
Using immersive virtual reality as a form of pain distraction during a brief "painful but tolerable" temperature.
Read the detailed description
This study will use Quantitative Sensory Testing (computer-controlled brief 10 second thermal pain stimuli) in healthy college students.
The primary aim is to conduct a randomized, controlled study with healthy volunteers to explore whether interacting with virtual objects in VR via a high tech interactive VR system makes VR significantly more effective/powerful compared to a less immersive passive VR system, vs. No VR, for reducing pain during quantitative sensory testing.
- Conditions
- Pain, Acute
- Being tested
- Virtual Reality psychological pain reduction
- Keywords
- pain control
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality psychological pain reductionBehavioural
attention distraction
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No treatment, side study to test the assumptions of our quantitative sensory testing pain paradigm |
| Low Tech/passive Virtual Reality first | Active comparator | Low Tech VR first brief test phase thermal stimulus + High Tech VR during a second test phase pain stimulus Receives: Behavioral: Virtual Reality psychological pain reduction |
| High Tech/interactive Virtual Reality first | Experimental | High Tech/Interactive VR during first brief test phase thermal stimulus + Low Tech VR during a second brief thermal stimulus. Receives: Behavioral: Virtual Reality psychological pain reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
participants rating of "worst pain "
using a single graphic rating scale, 0 = no pain, 10 = excruciating pain
Measured: immediately after each single 10 second test phase quantitative sensory test stimulus during a single visit
Secondary outcomes (2)
participants rating of "time spent thinking about pain"
using a single graphic rating scale, 0 = none of the time, 10 = all of the time
Measured: immediately after each single 10 second quantitative sensory test stimulus during a single visit
participants rating of "pain unpleasantness "
using a single graphic rating scale, 0 = no pain, 10 = excruciating pain
Measured: immediately after each single 10 second quantitative sensory test stimulus during a single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start30 Jan 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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 Pain, AcuteStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within subjects crossover design, VR treatment order randomized (some participants receive Low Tech VR + High Tech VR, some participants receive High Tech VR + Low Tech VR) and some participants receive No VR in a side study to test the assumptions of our QST testing pain paradigm. 1. No Virtual Reality (no treatment control side data to test QST paradigm assumptions). 2. Low Tech/passive Virtual Reality for 1st pain stimulus+High Tech for 2nd pain stimulus 3. High Tech/interactive VR for 1st pain stimulus +Low Tech for 2nd pain stimulus.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Hunter Hoffman, University of Washington
- Investigators
- Hunter Hoffman, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245475
- Sponsor's protocol ID
- STUDY00007801
- Other IDs
- R01GM042725
- Status last verified
- Oct 2021
- First submitted
- 23 Jan 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
Hoffman HG. Interacting with virtual objects via embodied avatar hands reduces pain intensity and diverts attention. Sci Rep. 2021 May 21;11(1):10672. doi: 10.1038/s41598-021-89526-4.
PubMed 34021173
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water-friendly Virtual Reality and Brief Thermal Pain
- ClinicalTrials.gov ID
- NCT04245475
- Acronym / sponsor ID
- STUDY00007801
- Conditions
- Pain, Acute
- Keywords
- pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 29 Jan 2020 (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.
Using immersive virtual reality as a form of pain distraction during a brief "painful but tolerable" temperature.
Detailed description
This study will use Quantitative Sensory Testing (computer-controlled brief 10 second thermal pain stimuli) in healthy college students.
The primary aim is to conduct a randomized, controlled study with healthy volunteers to explore whether interacting with virtual objects in VR via a high tech interactive VR system makes VR significantly more effective/powerful compared to a less immersive passive VR system, vs. No VR, for reducing pain during quantitative sensory testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Within subjects crossover design, VR treatment order randomized (some participants receive Low Tech VR + High Tech VR, some participants receive High Tech VR + Low Tech VR) and some participants receive No VR in a side study to test the assumptions of our QST testing pain paradigm. 1. No Virtual Reality (no treatment control side data to test QST paradigm assumptions). 2. Low Tech/passive Virtual Reality for 1st pain stimulus+High Tech for 2nd pain stimulus 3. High Tech/interactive VR for 1st pain stimulus +Low Tech for 2nd pain stimulus.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No treatment, side study to test the assumptions of our quantitative sensory testing pain paradigm |
| Low Tech/passive Virtual Reality first | Active comparator | Behavioral: Virtual Reality psychological pain reductionLow Tech VR first brief test phase thermal stimulus + High Tech VR during a second test phase pain stimulus |
| High Tech/interactive Virtual Reality first | Experimental | Behavioral: Virtual Reality psychological pain reductionHigh Tech/Interactive VR during first brief test phase thermal stimulus + Low Tech VR during a second brief thermal stimulus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
- Able to read, write and comprehend English
- Able to complete study measures
- Willing to follow our UW approved instructions
- 18 years of age or older
Key exclusion criteria (14 listed)
- People how have already previously participated in this same study (e.g., last quarter) are not eligible to participate again.
- Not enrolled in a course at the University of Washington Psychology Dept., participating in the UW Psychology subject pool
- Not be able to read, write and comprehend English
- Younger than 18 years of age.
- Not capable of completing measures
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 Reality psychological pain reductionattention distraction | Behavioural | High Tech/interactive Virtual Reality first, Low Tech/passive Virtual Reality first |
Primary outcome
participants rating of "worst pain "
Time frame: immediately after each single 10 second test phase quantitative sensory test stimulus during a single visit
using a single graphic rating scale, 0 = no pain, 10 = excruciating pain
2 secondary outcomes
participants rating of "time spent thinking about pain"
Time frame: immediately after each single 10 second quantitative sensory test stimulus during a single visit
participants rating of "pain unpleasantness "
Time frame: immediately after each single 10 second quantitative sensory test stimulus during a single visit
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 26 Oct 2021.
- Derived from this study: PubMed 34021173Hoffman HG. Interacting with virtual objects via embodied avatar hands reduces pain intensity and diverts attention. Sci Rep. 2021 May 21;11(1):10672. doi: 10.1038/s41598-021-89526-4.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Hunter Hoffman, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality psychological pain reduction in people with Pain, Acute, run by University of Washington 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 5 inclusion and 14 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 26 Oct 2021. 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?
participants rating of "worst pain " (time frame: immediately after each single 10 second test phase quantitative sensory test stimulus during a single visit). 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 NCT04245475, 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 26 Oct 2021.