Burn Clinical Trial
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?
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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