Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: Trial
Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: Trial
Children with burn injuries experience severe pain intensity during medical procedures
 despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain
 management recommend the combination of non-pharmacological and pharmacological interventions
 to enhance pain management and decrease the numerous side effects of analgesics. Virtual
 reality (VR) has gained growing consideration as a non-pharmacological method as it engages
 multiple senses and allows interactions with a virtual world. Oculus Rift ® is a new
 technology in VR that provides more immersiveness, at a relatively low cost, and could
 probably improve the management of pain and anxiety in burn care. It also has the potential,
 with appropriate custom software designed for burn pediatric patients, to reduce the
 cybersickness symptoms (nausea, dizziness) associated with VR. To the knowledge of the
 investigators, none of the pediatric hospitals across Canada have tested VR as a method of
 pain and anxiety management in children with burn injuries. Overall hypotheses: VR
 distraction via Oculus Rift ® could be an effective method to relieve pain, and anxiety, as
 well as a less traumatizing hospital experience, while promoting a more humanistic care
 environment by combining new technologies (VR via Oculus Rift ®) to standard analgesic
 interventions administered to these children. The expected results will have a direct effect
 on physical (pain) and psychological (anxiety, pain memories) health of the child. In
 addition, clinical implications may include other indicators of quality of care and economic
 benefits such as a wider range of motion of burned limbs and reduction in dosage of opioids
 and anxiolytic drugs administered.
1. BACKGROUND:

 Burn injuries are the leading cause of morbidity and mortality in children. They are
 associated with a lot of pain that is difficult to treat and can impede recovery, cause
 high levels of anxiety and alter future pain behaviors, resulting at times in chronic
 pain, paresthesia, or depression. Pain can also decrease participation in treatments
 such as physiotherapy resulting in poor health outcomes. Beyond the immediate pain
 experience, children may develop memories that are accurate, positively or negatively
 estimated (i.e., remembering more or less pain, respectively, as compared to initial
 pain reports). The way that children's memories are framed is important for future pain
 coping and distress at subsequent painful experiences. Moreover, it has been shown that
 pharmacological and non-pharmacological pain management strategies may buffer children
 from developing such biases in pain memories. Procedural pain is still largely managed
 pharmacologically mostly through the use of opioids, benzodiazepines and other
 pharmacological agents which cause a lot of side effects and do not always provide
 sufficient pain reduction. In recent years, the effectiveness of multimodal approaches
 combining medication with non-pharmacological interventions for procedural pain relief
 has been highlighted. Distraction techniques engaging multiple senses may grab the
 child's attention more than the techniques that only engage one sense (e.g, music),
 hence, the increasing interest in more immersive and interactive methods of distraction
 such as VR.

 VR is an active distraction method that allows the user to interact with an immersive
 environment generated by a computer stimulating different senses. A review of studies on
 VR, mostly conducted with adult burn patients, showed a 35 to 50% reduction in
 procedural pain while using VR. However, despite promising results, the use of VR in
 healthcare settings has been limited, mainly due to its high cost. Reviews have
 highlighted the need for more research but mostly for the development of more portable,
 less expensive and more developed VR systems that would promote pain reduction during
 burn procedures especially for children with burn injuries who are considered one of the
 most challenging burn populations. However, there has been a breakthrough in technology
 since 2014 when big scale companies started investing in VR development for commercial
 gaming. Facebook purchased the Oculus Rift® for mass production allowing access to the
 latest technology in VR at a relatively low cost. Oculus Rift® is a VR tool that
 provides a wide field of view, high resolution display, integrated 3D audio and motion
 detection. In addition, its highly immersive properties could help achieve more
 analgesia compared to other VR techniques as a review has shown that the sense of
 presence influences the effectiveness of VR-based analgesia. The sense of presence is a
 subjective psychological state of consciousness of being in the virtual world whereas
 immersiveness refers to the physical environment that could be quantified by measuring
 the field of view or the peripheral vision in the VR goggles. The availability of
 inexpensive yet highly immersive VR googles such as Oculus Rift® could increase the use
 of VR in pain management and burn settings while significantly improving its cost
 effectiveness. A single case study assessed the feasibility of a VR intervention via
 Oculus Rift® in one child of 11 years old with burn injuries during occupational
 therapy. The study showed a reduction in pain intensity and pain unpleasantness
 experienced by the patient, without any side effects. To the knowledge of the
 investigators, no other studies have tested the distraction via Oculus Rift® for
 procedural pain management in children with burn injuries undergoing painful
 physiotherapy treatments.

 2. AIM:

 The aim of this study is to assess the effect of distraction by VR via Oculus Rift® for
 the relief of procedural pain, anxiety and decrease memory of pain in children with burn
 injuries.

 Primary Research Question: In children aged 7 to 18 years, who have suffered burn
 injuries, does VR distraction via Oculus Rift® combined with analgesics provide better
 pain relief during painful procedures including dressing changes and physiotherapy than
 standard pharmacological treatment alone?

 Secondary Research Questions: a) In children aged 7 to 18 years, who have suffered burn
 injuries, does VR distraction via Oculus Rift® combined with analgesics provide better
 anxiety relief during dressing change and physiotherapy than standard pharmacological
 treatment alone? b) Does the use of VR distraction lead to less distressing memories of
 pain than standard pharmacological treatment alone? c) Does the use of VR distraction
 reduce the dose and side effects of analgesics used during burn wound dressing changes
 and physiotherapy in children?

 3. HYPOTHESES

 1. VR distraction via Oculus Rift® combined with analgesics is more effective than
 standard treatment (analgesics alone) to manage procedural pain of children with
 burn injuries.

 2. VR distraction via Oculus Rift® combined with analgesics is more effective than
 standard treatment (analgesics alone) on procedural anxiety of children with burn
 injuries.

 3. VR distraction via Oculus Rift® combined with analgesics will lead to less
 distressing memories of pain than standard treatment (analgesics alone) in children
 with burn injuries

 4. METHODS 4.1 Design. One-group within subject/crossover study design. Given the
 difficulty of ensuring a single or a double-blind condition, and in order to limit the
 interpersonal variability between participants, each child will serve as their own
 control and will receive both standard and experimental treatments during the same
 treatment session through a randomized order.

 4.2 Sample and Setting. Participants will be recruited through convenience sampling upon
 admission to the surgical-trauma burn unit at CHU Ste-Justine, Montreal (Qc), Canada. For a
 statistical power of 80%, an alpha of 0.05, and a significant difference of two points on a 0
 to 10 on the NRS pain scale, the size of the total desired sample is 40 participants who will
 serve as their own controls. The setting of the study is the main referral center for
 pediatric burns in Quebec. It receives nearly 60 admissions during the time of the year when
 there is a higher incidence of burns (April to October) and over all close to 100 admissions
 per year. One third of the total admissions are aged 7 years and older. Given a possible
 census of 33 admissions per year, it appears feasible to recruit around 40 patients over a
 period of two years. This is also the reason behind the choice of the design which would be
 the most feasible given the total population available for recruitment.

 .3 Interventions. A) Standard pharmacological treatment B) Standard treatment in addition to
 Virtual Reality distraction via Oculus Rift

 4.4. Measures. Pain, anxiety and comfort measures will be taken before the treatment
 (physiotherapy or dressing change) session (T1) (for expectancy and baseline state), after
 the first sequence of the session (T2) and after the second sequence of the session (T3).
 Healthcare professionals will be asked to fill an anonymous satisfaction questionnaire 30
 minutes after the end of the session (T4). Memories of pain/anxiety will be assessed at least
 24 hours after each procedure (T5).

 4.5 Study proceedings. Physiotherapy and dressing change sessions typically last between 10
 and 20 minutes. The duration will be divided in two sequences of the same duration (5 to 10
 minutes) where the participant receives the same treatment (range-of-motion exercises for
 physiotherapy or wound cleaning and gauzes application for dressing changes) by the same
 healthcare professional (physiotherapist or nurse). For one sequence, only the standard
 pharmacological treatment will be administered and for the other sequence, patients will
 receive the standard pharmacological treatment in addition to the virtual reality distraction
 via OR. The order of sequences will be randomized.

 4.6 Data analysis plan. Multivariate Analyses and quantitative comparisons will be conducted
 within and between subjects for the dependent variables for repeated measures. The mean
 difference in pain scores of patients at each time-period will be compared using a paired
 t-test. Since the use of rescue medication is a potential indication of a treatment failure,
 the primary analysis will be supplemented by an analysis comparing the proportion of patients
 receiving rescue medication anytime during the procedure. Interpretation of the primary
 analyses will be made with reference to the data regarding rescue medication use. Data
 collected on dichotomous variables will be analyzed using a chi-square test and post-hoc
 analyses if the results are statistically significant.
Inclusion Criteria:

 -  suffer from a burn injury requiring wound dressing change or physiotherapy

 -  presence of a consenting parent who can understand, read and write either French or
 English

 Exclusion Criteria:

 -  requiring intensive care

 -  having a diagnosed cognitive impairment

 -  are unconscious or intubated during dressing change or physiotherapy

 -  suffer from epilepsy (considering the nature of the intervention)

 -  allergic to opioids or other analgesics used for standard pharmacological treatment

 -  having burn injuries on the face preventing the use of the Oculus Rift headset