BurnsNCT00593086
Virtual Reality in Burn Pain Management
A study testing Pain management in people with Burns and Pain, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn patients experiencing severe procedural pain during wound care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Pain management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or oler with thermal injury
- Understands English
- patient perception of previous wound care procedural pain is greater than 6 on a numeric pain scal of 0-10 where 0= no pain and 10=worst pain ever experienced
- ability to use a computer mouse or hit the space bar on a computer keyboard
Who cannot join
- unhealed burned wounds on face, neck or head
- history of severe susceptibility to motion sickness
- presence of open woun ds to the hands that cannot be covered with a dressing while operating the control button
- patients who report a feeling of anxiety or discomfort while viewing the Snow World software on a computer without the helmet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Virtual Reality Video Games to Control Procedural Pain During Burn Wound Care
To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn patients experiencing severe procedural pain during wound care.
Read the detailed description
This is a prospective, randomized cross-over study of the safety and effectiveness of the use of a virtual reality distraction intervention to management procedural pain during burn wound care. Up to 20 subjects will be enrolled until 12 complete the study.
- Being tested
- Pain management, Standard of care/no virtual reality game
- Keywords
- wound care
- Medical subject headings
- Burns, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain managementProcedure or surgery
Also called Snow World or Standard of care
Pain mamagement for burn care procedures.
Standard of care/no virtual reality gameOther
Also called Standard of care
no intervention for standard of care
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Standard of care pain management Receives: Procedure: Pain management; Other: Standard of care/no virtual reality game |
| B | Experimental | SnoWorld Virtual Reality Game Receives: Procedure: Pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2010
- Study completionJun 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 BurnsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Christopher Maani, MD, Principal investigator, United States Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593086
- Sponsor's protocol ID
- H-06-024
- Status last verified
- Feb 2013
- First submitted
- 26 Dec 2007
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Patterson DR, Hoffman HG, Weichman SA, Jensen MP, Sharar SR. Optimizing control of pain from severe burns: a literature review. Am J Clin Hypn. 2004 Jul;47(1):43-54. doi: 10.1080/00029157.2004.10401474. No abstract available.
PubMed 15376608
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality Video Games to Control Procedural Pain During Burn Wound Care
- ClinicalTrials.gov ID
- NCT00593086
- Acronym / sponsor ID
- H-06-024
- Keywords
- wound care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Jun 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Jan 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.
To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn patients experiencing severe procedural pain during wound care.
Detailed description
This is a prospective, randomized cross-over study of the safety and effectiveness of the use of a virtual reality distraction intervention to management procedural pain during burn wound care. Up to 20 subjects will be enrolled until 12 complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Pain management, Other: Standard of care/no virtual reality gameStandard of care pain management |
| B | Experimental | Procedure: Pain managementSnoWorld Virtual Reality Game |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or oler with thermal injury
- Understands English
- patient perception of previous wound care procedural pain is greater than 6 on a numeric pain scal of 0-10 where 0= no pain and 10=worst pain ever experienced
- ability to use a computer mouse or hit the space bar on a computer keyboard
Key exclusion criteria (4 listed)
- unhealed burned wounds on face, neck or head
- history of severe susceptibility to motion sickness
- presence of open woun ds to the hands that cannot be covered with a dressing while operating the control button
- patients who report a feeling of anxiety or discomfort while viewing the Snow World software on a computer without the helmet
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 |
|---|---|---|
| Pain managementAlso: Snow World or Standard of carePain mamagement for burn care procedures. | Procedure or surgery | A, B |
| Standard of care/no virtual reality gameAlso: Standard of careno intervention for standard of care | Other | A |
Primary outcome
There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care
Time frame: 48 hours
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 27 Feb 2013.
- Background: PubMed 15376608Patterson DR, Hoffman HG, Weichman SA, Jensen MP, Sharar SR. Optimizing control of pain from severe burns: a literature review. Am J Clin Hypn. 2004 Jul;47(1):43-54. doi: 10.1080/00029157.2004.10401474. No abstract available.
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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.
Christopher Maani, MD principal investigator
United States Army Institute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain management in people with Burns and Pain, run by United States Army Institute of Surgical Research 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 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 27 Feb 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.
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?
There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care (time frame: 48 hours). 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 NCT00593086, 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 27 Feb 2013.