BurnNCT00591448
Study in the Use of Virtual Reality as an Adjunct to Pain Control in Burn Patients
A study testing Virtual Reality (VR) in people with Burn, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of Virtual Reality (VR) technology during Physical Therapy (PT) and/or Occupational Therapy (OT) for patients with burns. Research questions: Do patients have increased joint Range of Motion (ROM) and reduced pain when using VR during PT compared to PT/OT when VR is not… Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn
- What is being tested?
- Virtual Reality (VR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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
- Pain associated with PT/OT
- Age six years and above
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
Show all 10Show fewer
- Extreme susceptibility to motion sickness
- Reports having no pain/full range of motion during physical therapy
- Seizure disorder
- Frostbite
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement of Pain Management in Burn Patients Using Virtual Reality in Conjunction With Standard Opioids and Sedatives
The purpose of this study is to evaluate the use of Virtual Reality (VR) technology during Physical Therapy (PT) and/or Occupational Therapy (OT) for patients with burns. Research questions: Do patients have increased joint Range of Motion (ROM) and reduced pain when using VR during PT compared to PT/OT when VR is not used? Do scores on an imaging ability scale correlate with the effects of VR when used with PT/OT? Do adults and children differ in their ability to engage in the virtual world?
Read the detailed description
The purpose of this study is to evaluate the use of virtual reality (VR) technology during Physical Therapy (PT) and/or Occupational Therapy (OT) for patients with burns. Due to the pain that many burn patients experience during PT/OT, we are searching for non-medicinal methods of decreasing their pain. The question we will address is: does VR use during PT/OT help to increase Range of Motion (ROM) and decrease pain intensity?
Recovery from a trauma can be hindered by the presence of acute pain. Unfortunately for burn victims, physical and occupational therapies remains an area of significant evoked pain. PT/OT is an integral part of the burn recovery and starts early in the course of treatment. PT/OT is necessary to maintain elasticity of healing skin and thereby promote functional range of motion of affected joints. If the patient is unable to participate in PT/OT due to pain, joint contractures can occur and surgical release of the contracture can become necessary.
Although pain during PT/OT can be treated with opioids, there are several drawbacks to the use of analgesics alone. Side effects, the development of opioid tolerance, and the inability of the drugs to adequately control pain are some of the disadvantages. Supplemental use of nonpharmacologic techniques, along with opioid therapy, has been found to be effective in reducing pain and anxiety. In particular, distraction has been found to be useful to minimize burn pain (Miller, 1992; Patterson, 1995). Virtual reality, due to its immersive nature that includes sight, sound, and sometimes touch, may be an even more effective method of distraction than traditional methods such as video movies or interactive video games. To explain these non-pharmacologic analgesic effects, investigators propose that the illusion of going in to the virtual world draws the patient's attention. Conscious attention is required for the experience of pain (Chapman and Nakamura, 1999; Eccleston and Crombez, 1999). The interactive nature of the immersive virtual reality make VR unusually attention grabbing, leaving less attention available to process incoming pain signals (Hoffman, Patterson and Carrougher, 2000).
In 1996, Hunter Hoffman and David Patterson co-originated new techniques using immersive virtual reality for pain control. Virtual reality is a familiar format to children and young adults, who grew up playing videogames. Like videogames, it is an environment that is stimulated by a computer. However, in virtual reality, visual experiences are presented through special stereoscopic goggles. Virtual reality simulations can include additional sensory information, such as sound through speakers and touch through cyber-gloves. Users interact with a virtual reality environment either through a keyboard, mouse, or a specially designed device. These systems are described as "fully immersive" as the user is surrounded by virtual reality stimulation. Simulated environments have been used to mimic videogames and real-world situations, such as pilot training, driver training, museum tours, and underwater expeditions. Researchers have found that immersive virtual reality distraction can reduce patient's pain rating during severe burn wound care by 30% to 50% (Hoffman, Patterson et al., 2004; Hoffman, Patterson and Carrougher, 2000). Patients receiving adjunctive VR during physical therapy reported large reductions in the amount of time spent thinking about pain, pain intensity (worst pain) and in how unpleasant they found their pain (Hoffman, Patterson, Carrougher and Sharar, 2001). In a recent fMRI brain scan study, participants reported large reductions in subjective pain when in VR compared to no VR during their scan. The controlled laboratory fMRI study further showed that VR analgesia was accompanied by large reductions in pain-related brain activity (Hoffman, Richards et al., 2004).
The proposed study will replicate and extend the work of Hoffman, Patterson and colleagues. Using similar experimental techniques, patients will serve as their own controls to evaluate the effects of the use of VR during physical therapy/occupational therapy for burn care compare to no VR during therapy during several sessions. An imagery scale will be completed by subjects prior to the first session to determine if there is a correlation between imagery scores and the effects of the VR. This may help identify patients who will benefit from VR in the future.
Prior research has shown that some patients respond better than others to adjunct therapy than others. Caregivers may be reluctant to initiate such therapies unless they are certain it will be beneficial. Kwekkeboom has developed and tested the Imaging Ability Questionnaire (IAQ) and the Kids Imaging Ability Questionnaire (KIAQ) to help determine who would benefit from this type of intervention (Kwekkeboom, Maddox, West, 2000). Participants will be completing these questionnaires prior to the first VR therapy session. The instruments for both groups will be the same with the exception of the "imaging ability". Each group will complete an "imaging ability", but one has been designed especially for children, the other for adults.
The majority of the research using VR has been focused on children. Children and adolescents are accustom to playing video games and may have an easier transition into the VR world. We are interested in the adult's ability to become engaged in VR compared to children.
Potential benefits include:
Speedier Physical Rehabilitation a Decreased Pain Experience During Necessary Care Decreased Pain Med Requirements Addition of Variety to Daily Activities Altruistic Benefit Derived From the Possible Future Benefit to Others.
- Conditions
- Burn
- Being tested
- Virtual Reality (VR)
- Keywords
- Thermal injury
- 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 (VR)Other
See above
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Patients with burns participate in VR during occupational therapy (OT) or physical therapy (PT) sessions ranging from 2 to 9 min in length Receives: Other: Virtual Reality (VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved pain scores
Measured: 18 months
Secondary outcomes (1)
There are no secondary outcomes
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Faucher, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591448
- Sponsor's protocol ID
- H-2006-0380
- Status last verified
- Oct 2012
- First submitted
- 26 Dec 2007
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Pain Management in Burn Patients Using Virtual Reality in Conjunction With Standard Opioids and Sedatives
- ClinicalTrials.gov ID
- NCT00591448
- Acronym / sponsor ID
- H-2006-0380
- Conditions
- Burn
- Keywords
- Thermal injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 11 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.
The purpose of this study is to evaluate the use of Virtual Reality (VR) technology during Physical Therapy (PT) and/or Occupational Therapy (OT) for patients with burns. Research questions: Do patients have increased joint Range of Motion (ROM) and reduced pain when using VR during PT compared to PT/OT when VR is not used? Do scores on an imaging ability scale correlate with the effects of VR when used with PT/OT? Do adults and children differ in their ability to engage in the virtual world?
Detailed description
The purpose of this study is to evaluate the use of virtual reality (VR) technology during Physical Therapy (PT) and/or Occupational Therapy (OT) for patients with burns. Due to the pain that many burn patients experience during PT/OT, we are searching for non-medicinal methods of decreasing their pain. The question we will address is: does VR use during PT/OT help to increase Range of Motion (ROM) and decrease pain intensity?
Recovery from a trauma can be hindered by the presence of acute pain. Unfortunately for burn victims, physical and occupational therapies remains an area of significant evoked pain. PT/OT is an integral part of the burn recovery and starts early in the course of treatment. PT/OT is necessary to maintain elasticity of healing skin and thereby promote functional range of motion of affected joints. If the patient is unable to participate in PT/OT due to pain, joint contractures can occur and surgical release of the contracture can become necessary.
Although pain during PT/OT can be treated with opioids, there are several drawbacks to the use of analgesics alone. Side effects, the development of opioid tolerance, and the inability of the drugs to adequately control pain are some of the disadvantages. Supplemental use of nonpharmacologic techniques, along with opioid therapy, has been found to be effective in reducing pain and anxiety. In particular, distraction has been found to be useful to minimize burn pain (Miller, 1992; Patterson, 1995). Virtual reality, due to its immersive nature that includes sight, sound, and sometimes touch, may be an even more effective method of distraction than traditional methods such as video movies or interactive video games. To explain these non-pharmacologic analgesic effects, investigators propose that the illusion of going in to the virtual world draws the patient's attention. Conscious attention is required for the experience of pain (Chapman and Nakamura, 1999; Eccleston and Crombez, 1999). The interactive nature of the immersive virtual reality make VR unusually attention grabbing, leaving less attention available to process incoming pain signals (Hoffman, Patterson and Carrougher, 2000).
In 1996, Hunter Hoffman and David Patterson co-originated new techniques using immersive virtual reality for pain control. Virtual reality is a familiar format to children and young adults, who grew up playing videogames. Like videogames, it is an environment that is stimulated by a computer. However, in virtual reality, visual experiences are presented through special stereoscopic goggles. Virtual reality simulations can include additional sensory information, such as sound through speakers and touch through cyber-gloves. Users interact with a virtual reality environment either through a keyboard, mouse, or a specially designed device. These systems are described as "fully immersive" as the user is surrounded by virtual reality stimulation. Simulated environments have been used to mimic videogames and real-world situations, such as pilot training, driver training, museum tours, and underwater expeditions. Researchers have found that immersive virtual reality distraction can reduce patient's pain rating during severe burn wound care by 30% to 50% (Hoffman, Patterson et al., 2004; Hoffman, Patterson and Carrougher, 2000). Patients receiving adjunctive VR during physical therapy reported large reductions in the amount of time spent thinking about pain, pain intensity (worst pain) and in how unpleasant they found their pain (Hoffman, Patterson, Carrougher and Sharar, 2001). In a recent fMRI brain scan study, participants reported large reductions in subjective pain when in VR compared to no VR during their scan. The controlled laboratory fMRI study further showed that VR analgesia was accompanied by large reductions in pain-related brain activity (Hoffman, Richards et al., 2004).
The proposed study will replicate and extend the work of Hoffman, Patterson and colleagues. Using similar experimental techniques, patients will serve as their own controls to evaluate the effects of the use of VR during physical therapy/occupational therapy for burn care compare to no VR during therapy during several sessions. An imagery scale will be completed by subjects prior to the first session to determine if there is a correlation between imagery scores and the effects of the VR. This may help identify patients who will benefit from VR in the future.
Prior research has shown that some patients respond better than others to adjunct therapy than others. Caregivers may be reluctant to initiate such therapies unless they are certain it will be beneficial. Kwekkeboom has developed and tested the Imaging Ability Questionnaire (IAQ) and the Kids Imaging Ability Questionnaire (KIAQ) to help determine who would benefit from this type of intervention (Kwekkeboom, Maddox, West, 2000). Participants will be completing these questionnaires prior to the first VR therapy session. The instruments for both groups will be the same with the exception of the "imaging ability". Each group will complete an "imaging ability", but one has been designed especially for children, the other for adults.
The majority of the research using VR has been focused on children. Children and adolescents are accustom to playing video games and may have an easier transition into the VR world. We are interested in the adult's ability to become engaged in VR compared to children.
Potential benefits include:
Speedier Physical Rehabilitation a Decreased Pain Experience During Necessary Care Decreased Pain Med Requirements Addition of Variety to Daily Activities Altruistic Benefit Derived From the Possible Future Benefit to Others.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual Reality (VR)Patients with burns participate in VR during occupational therapy (OT) or physical therapy (PT) sessions ranging from 2 to 9 min in length |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 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
- Pain associated with PT/OT
Key exclusion criteria (10 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 (VR)See above | Other | Virtual Reality |
Primary outcome
Improved pain scores
Time frame: 18 months
1 secondary outcome
There are no secondary outcomes
Time frame: 18 months
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 17 Oct 2012.
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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.
Lee Faucher, MD principal investigator
University of Wisconsin, Madison
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 (VR) in people with Burn, run by University of Wisconsin, Madison 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 6 inclusion and 10 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 17 Oct 2012. 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?
Improved pain scores (time frame: 18 months). 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 17 Oct 2012.