BurnPhase 2/3VRPT/H2O/RTNCT00261690
Virtual Reality Pain Control During Burn Wound Care
A Phase 2/3 study testing Virtual Reality Distraction in people with Burn, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
Trial summary
Using Virtual Reality as a form of Distraction during Burn Care. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Burn
- What is being tested?
- Virtual Reality Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Mar 2012
- Phase
- Phase 2/3
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Able to complete subjective evaluations of pain
- English-speaking
- Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
- Able to communicate orally
Who cannot join
- Incapable of indicating subjective evaluation of pain
- Non-English-speaking
- Severe head or neck injury or other medical conditions that prohibit patient from wearing VR helmet
- Demonstrating delirium, psychosis, or Organic Brain Disorder
- Unable to communicate verbally
- Significant developmental disability
- Extreme susceptibility to motion sickness
- Reports having no problem with pain during wound care.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington; Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Use of Virtual Reality for Adjunctive Treatment of Burn Pain
Using Virtual Reality as a form of Distraction during Burn Care.
Read the detailed description
The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' procedural burn pain.
- Conditions
- Burn
- Being tested
- Virtual Reality Distraction
- Keywords
- Virtual Reality Distraction
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionBehavioural
Using virtual reality distraction during a procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Virtual Reality distraction Receives: Behavioral: Virtual Reality Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
We use GRS, McGill to measure the outcome.
Measured: once a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startFeb 2002
- Primary completionMar 2012
- Study completionMar 2012
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 BurnStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, David R. Patterson, National Institute of General Medical Sciences (NIGMS)
- Investigators
- David R. Patterson, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261690
- Sponsor's protocol ID
- 13289-C
- Other IDs
- R01GM042725
- Acronym
- VRPT/H2O/RT
- Status last verified
- Jun 2012
- First submitted
- 2 Dec 2005
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoffman HG, Patterson DR, Magula J, Carrougher GJ, Zeltzer K, Dagadakis S, Sharar SR. Water-friendly virtual reality pain control during wound care. J Clin Psychol. 2004 Feb;60(2):189-95. doi: 10.1002/jclp.10244.
PubMed 14724926
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality for Adjunctive Treatment of Burn Pain
- ClinicalTrials.gov ID
- NCT00261690
- Acronym / sponsor ID
- VRPT/H2O/RT / 13289-C
- Conditions
- Burn
- Keywords
- Virtual Reality Distraction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2002
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 Dec 2005 (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.
Using Virtual Reality as a form of Distraction during Burn Care.
Detailed description
The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' procedural burn pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Virtual Reality DistractionVirtual Reality distraction |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Able to complete subjective evaluations of pain
- English-speaking
- Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
- Able to communicate orally
Key exclusion criteria (8 listed)
- Incapable of indicating subjective evaluation of pain
- Non-English-speaking
- Severe head or neck injury or other medical conditions that prohibit patient from wearing VR helmet
- Demonstrating delirium, psychosis, or Organic Brain Disorder
- Unable to communicate verbally
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 DistractionUsing virtual reality distraction during a procedure | Behavioural | 1 |
Primary outcome
We use GRS, McGill to measure the outcome.
Time frame: once a day
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 19 Apr 2013.
- Background: PubMed 14724926Hoffman HG, Patterson DR, Magula J, Carrougher GJ, Zeltzer K, Dagadakis S, Sharar SR. Water-friendly virtual reality pain control during wound care. J Clin Psychol. 2004 Feb;60(2):189-95. doi: 10.1002/jclp.10244.
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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.
David R. Patterson, Ph.D. 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 Phase 2/3 study testing Virtual Reality Distraction in people with Burn, run by National Institute of General Medical Sciences (NIGMS) 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 4 inclusion and 8 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 19 Apr 2013. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
We use GRS, McGill to measure the outcome. (time frame: once a day). 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 NCT00261690, 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 19 Apr 2013.