Virtual Reality for Pain Relief in the Emergency Room for Reduction of Fractures and Joint Dislocations

Pain control is a common challenge in the Emergency Department(ED). Effective
pain management influences both patient and physician outcomes and experience.
Many ED patients endure significant pain during procedures. Current pain
control approaches still rely heavily on pharmacologic agents. Pharmacological
agents have the risk of adverse reactions, and are not always satisfactory to
achieve sufficient periprocedural analgesia. `
Drawing on the gate control theory, a non-pharmacological alternative for
procedural pain management could be Virtual Reality(VR). VR offers the
potential to divert patients* attention into an alternative reality, which
reduces the focus on pain. Such an intervention could reduce the use of
pharmacological agents and improve efficiencies in staff deployment, as well as
improving the patient*s experience. Several studies have shown that VR is an
effective tool in reducing acute pain experienced during various medical
procedures such as labour contractions, episiotomy repair, periodontal
procedures or burn-related pain, but did not yet demonstrate any feasability in
the ED besides the use on children getting intravascular access. Previous
studies have typically focussed on small sample sizes and/or homogenous patient
populations. These studies have also often relied heavily on self-report
measures as a primary outcome, which is particularly problematic in VR studies
wherein patients cannot be blinded to the intervention. To date, there is
little evidence on the usability and performance of VR for pain control during
medical procedures performed in the ED. The purpose of this study is to further
investigate the use of VR for procedural pain management in the ED.

Primary Objective:
Can VR reduce periprocedural and postprocedural pain during reduction of
fractures and joint dislocations in the ED?

Secondary Objectives:
What are the effects of VR on peri-procedural anxiety?
Does the level of peri-procedural anxiety influence the success of VR?
What are the differences in adverse events between the intervention and control
group?
What effect does the use of VR in ED procedures have on patient, parent (if
applicable) and physician satisfaction?
What effect does the use of VR in ED procedures have on the duration of
treatment in the ED?
How often was the use of antiemetics necessary in those receiving VR?
Was the procedure performed succesfully?

A prospective unblinded randomised controlled trial will be conducted in the ED
of the Elisabeth TweeSteden hospital in Tilburg, the Netherlands. Patients will
be randomised to the intervention group (VR) or the control group (standard of
care).

A Virtual Reality(VR) Head Mounted Display(HMD) with an additional wristband
photoplethysmography sensor will be applied in the intervention group, in
addition to the administration of paracetamol and a NSAID.
In the control group, a standard of care approach will be used.

a. Level of knowledge about mechanism of action
Drawing on the gate control theory, VR will achieve its pain and anxiety relief
by distracting the patient. In daily practice, distraction in children is often
accomplished by viewing a movie or listening to music. Recent literature
suggests the same applies to adults. VR will achieve this distraction by
starting an application that will display a computer generated environment in
front of the patient's eyes. The eyes and ears will be covered up by the device
in order to achieve full immersion while the patient is visually and auditory
isolated from the real environment., thereby creating a full immersion
experience. This immersion will accomplish the feeling of presence in virtual
reality. It is suggested that a higher feeling of presence will attain a higher
degree of relief of pain and anxiety because less attention is available for
the perception of pain.

b. Previous exposure of human beings with the test product(s) and/or products
with a similar biological mechanism
As described in chapter 6, the Pico Neo is a relatively new product and so
there are not yet any clinical studies reported using this device. It is
comparable to HMD*s already in clinical use such as the HTC Vive or Oculus
Rift, with the added benefit of being lighter in weight and untethered
(wireless). Previous studies have reported VR HMD*s to be well-tolerated by
patients .

e. Analysis of potential effect
Meta-analyses have been performed to review the potential benefits and side
effects of VR.
Cybersickness is one of the most commonly described potential side effects.
While this may be unpleasant, it will not have any long term effects. Weech et
al. suggest that presence and cybersickness are negatively correlated though
presence is necessary for adequate immersion and thus pain relief and relief of
anxiety.
The incidence of cybersickness has been significantly reduced with the
advancements of technology but some physical complaints may still occur.

g. Study population
For both the adult patients and the young adolescents, whom will be included in
our study, there has been a decent amount of research regarding the
effectiveness of VR on acute and the chronic pain, including systematic
reviews. These suggest positive effects on pain and anxiety. Though these
studies point towards a favourable outcome, they do not particularly highlight
effectiveness in an acute ED setting.
Some studies have been performed in the acute setting of the ED and suggest a
positive effect on pain, anxiety and even anger. We propose this study to
enlighten us further concerning the effectiveness in acute periprocedural pain
in the ED.

h. Interaction with other products
None. To avoid dizziness we will exclude patients that received opioids.

i. Predictability of effect
Mallari et al.l reviewed the literature in 2019 and included 20 articles, 10 of
which addressed acute pain or procedural pain, nearly all of which showed a
favourable outcome on pain.
As described by Eijlers et al. age might be a predictor in the effectiveness of
VR. They showed the effect size of VR on pain decreased with 0.26 when age
increased by 1 year, suggesting a favourable effect in younger children. Age
was a significant predictor of the effect of VR on pain (P < .001). They found
similar results for anxiety.

j. Can effects be managed?
Relief of pain and anxiety is the main goal of the intervention and is
desirable. As described above, negative side effects in the form of
cybersickness are possible, but with newer equipment the incidence of these
symptoms will most likely be minimised. These effects might be alleviated with
the removal of the VR headset and the use of antiemetics if necessary. In the
case of insufficient pain relief, patients will be treated by the physician
with additional analgesic agents and/or procedural sedation if necessary.