Pain4DONCT00682682
Reducing Brief Thermal and Electrical Pain (Four Study Days)
A study testing Virtual Reality video distraction and Virtual Reality video game in people with Pain, run by University of Washington at 1 site in United States.
Trial summary
Ultimately, the purpose of the present study is to help improve pain control in burn patients during wound care and physical therapy, where pain levels with opioids alone are often excessively high. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Virtual Reality video distraction and Virtual Reality video game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women 18-45 years old
- Normal height and weight ratio
Who cannot join
- women who are pregnant and nursing
- history of substance abuse
- access to opioids in the workplace
- smokes cigarettes
- history of medical problems with the following: heart, lungs, liver, kidneys, endocrine, neurologic, migraines, or psychiatric requiring medical intervention
- anemia
Show all 11Show fewer
- chronic pain
- allergy or hypersensitivity to opioids, velcro, or latex
- severe motion sickness
- unusual sensitivity or lack of sensitivity to pain
- sensitive skin or feet
Trial locations and contacts
1 site in 1 country.
About this study
Ultimately, the purpose of the present study is to help improve pain control in burn patients during wound care and physical therapy, where pain levels with opioids alone are often excessively high.
This study measures how much virtual reality pain distraction reduces pain compared to traditional opioid pain meds, and whether there is additional pain reduction when Virtual Reality distraction + Opioids are combined. In addition to studying the amount of pain reduction, this study will also measure side effects (if any) of the two treatments (Virtual Reality pain distraction and Opioids) alone and when combined.
Read more
Healthy volunteers will be recruited from advertisements will undergo a trial of the pain testing. They will receive a series of brief stimuli (at a painful but tolerable safe intensities they select and approve during baseline testing), separated by intervals of no pain.
Participants will rate how much pain they felt after each brief stimulus, and will fill out side effects questionnaires after finishing the pain session.
Subjects will participate in each of the four conditions in which the order is randomized.
- No opioids (0ng/ml hydromorphone) + no virtual reality Snow World distraction
- No opioids + yes virtual reality Snow World distraction
- Moderate dose of pain medicine (4ng/ml hydromorphone) + no virtual reality
- Moderate dose of pain medicine + yes virtual reality Snow World distraction
It is our hypothesis that VR distraction + opioids will show a reduced perception of pain in subjects more than opioids alone or no intervention (control).
Read the detailed description
In this study, healthy volunteers aged 18-45 who sign up after seeing a flyer or web posting are screened for exclusion via telephone interview, and if eligible, a health background interview. Initial contact will come from the subject's response to recruitment materials. Subjects may withdraw at any time.
These safe laboratory studies with healthy volunteers are designed to help us figure out how to maximize the effectiveness of virtual reality when used with severe burn patients at Harborview Burn Center
- Conditions
- Pain
- Being tested
- Virtual Reality video distraction, Virtual Reality video game
- Keywords
- Pain distraction, Analgesic interventions, Burn patients
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality video distractionOther
Virtual Reality involves wearing a helmet and playing a game called "Snow world". This game has sound and is presented in 3D format. This game has immersive qualities that help user feel as if they are "in" the game.
Virtual Reality video gameOther
Virtual Reality video games involve wearing a helmet with vision and sound. this game is presented in 3D which gives the user the feeling of being "in" the game. The game used for this study is "Snow World"
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | all study participants will have 4 visits: VR alone, VR + opioid, opioid alone, and no VR/opioid Receives: Other: Virtual Reality video distraction; Other: Virtual Reality video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of VR distraction with and without opioid when pain stimulus is applied.
Measured: at completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startDec 2007
- Primary completionMay 2008
- Study completionDec 2008
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris Hoffer, University of Washington
- Investigators
- Samuel R. Sharar, MD, Principal investigator, Professor, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682682
- Sponsor's protocol ID
- 030091D
- Acronym
- 4DO
- Status last verified
- Sep 2011
- First submitted
- 20 May 2008
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Brief Thermal and Electrical Pain (Four Study Days)
- ClinicalTrials.gov ID
- NCT00682682
- Acronym / sponsor ID
- 4DO / 030091D
- Conditions
- Pain
- Keywords
- Pain distraction, Analgesic interventions, Burn patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 May 2008 (estimated)
- 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.
Ultimately, the purpose of the present study is to help improve pain control in burn patients during wound care and physical therapy, where pain levels with opioids alone are often excessively high.
This study measures how much virtual reality pain distraction reduces pain compared to traditional opioid pain meds, and whether there is additional pain reduction when Virtual Reality distraction + Opioids are combined. In addition to studying the amount of pain reduction, this study will also measure side effects (if any) of the two treatments (Virtual Reality pain distraction and Opioids) alone and when combined.
Healthy volunteers will be recruited from advertisements will undergo a trial of the pain testing. They will receive a series of brief stimuli (at a painful but tolerable safe intensities they select and approve during baseline testing), separated by intervals of no pain.
Participants will rate how much pain they felt after each brief stimulus, and will fill out side effects questionnaires after finishing the pain session.
Subjects will participate in each of the four conditions in which the order is randomized.
- No opioids (0ng/ml hydromorphone) + no virtual reality Snow World distraction
- No opioids + yes virtual reality Snow World distraction
- Moderate dose of pain medicine (4ng/ml hydromorphone) + no virtual reality
- Moderate dose of pain medicine + yes virtual reality Snow World distraction
It is our hypothesis that VR distraction + opioids will show a reduced perception of pain in subjects more than opioids alone or no intervention (control).
Detailed description
In this study, healthy volunteers aged 18-45 who sign up after seeing a flyer or web posting are screened for exclusion via telephone interview, and if eligible, a health background interview. Initial contact will come from the subject's response to recruitment materials. Subjects may withdraw at any time.
These safe laboratory studies with healthy volunteers are designed to help us figure out how to maximize the effectiveness of virtual reality when used with severe burn patients at Harborview Burn Center
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Virtual Reality video distraction, Other: Virtual Reality video gameall study participants will have 4 visits: VR alone, VR + opioid, opioid alone, and no VR/opioid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women 18-45 years old
- Normal height and weight ratio
Key exclusion criteria (11 listed)
- women who are pregnant and nursing
- history of substance abuse
- access to opioids in the workplace
- smokes cigarettes
- history of medical problems with the following: heart, lungs, liver, kidneys, endocrine, neurologic, migraines, or psychiatric requiring medical intervention
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 video distractionVirtual Reality involves wearing a helmet and playing a game called "Snow world". This game has sound and is presented in 3D format. This game has immersive qualities that help user feel as if they are "in" the game. | Other | 1 |
| Virtual Reality video gameVirtual Reality video games involve wearing a helmet with vision and sound. this game is presented in 3D which gives the user the feeling of being "in" the game. The game used for this study is "Snow World" | Other | 1 |
Primary outcome
Efficacy of VR distraction with and without opioid when pain stimulus is applied.
Time frame: at completion of study
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 13 Sep 2011.
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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.
Samuel R. Sharar, MD principal investigator
Professor, 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 video distraction and Virtual Reality video game in people with Pain, 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 2 inclusion and 11 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 13 Sep 2011. 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?
Efficacy of VR distraction with and without opioid when pain stimulus is applied. (time frame: at completion of study). 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 13 Sep 2011; AzTrials last refreshed its copy on 31 Oct 2026.