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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • United States

    Madison, Wisconsin, 53792

Other trials in United States

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 groups in NCT00591448
Study groupRoleWhat they receive
Virtual RealityExperimentalPatients 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.

  1. Improved pain scores

    Measured: 18 months

Secondary outcomes (1)
  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.

  1. First posted11 Jan 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

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)
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

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.

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