Virtual Reality Distraction for Procedural Pain Management and Anxiety in Children With Burn Injuries : A Pilot Study
Condition: Burn; Child; Pain; Anxiety
MeSH terms: Burns; Anxiety Disorders
Study type: Interventional

Summary: 
      Procedural pain is the most intense and often undertreated pain associated with burn
      injuries. The use of analgesics does not always provide optimal relief and is accompanied by
      several side effects. Indeed, children with burn injuries still experience severe pain
      intensity during procedures despite the fact that doses of analgesics used with this
      population has almost doubled in the last twenty years. 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. Distraction has been identified among the most effective
      non-pharmacological interventions for pain as it diverts the child's attention to an
      attractive element, hindering the perception of the painful stimuli. Virtual reality (VR) is
      a method of active distraction that offers the child a multi-sensory immersive interaction
      that found many applications for pain management in adult patients. However, very few studies
      have tested the efficacy of distraction by virtual reality on procedural pain and anxiety in
      children with burn injuries.

      The aim of this study is to assess the feasibility and preliminary efficacy of a virtual
      reality prototype developed specifically for the hydrotherapy room of children under seven
      years old for the relief of procedural pain and anxiety in children with burn injuries.
      HYPOTHESES: a) VR distraction is a feasible non-pharmacological intervention for pain
      management during hydrotherapy, b) VR distraction combined with analgesics is more
      efficacious than standard treatment (analgesics alone) on procedural pain and anxiety
      (hydrotherapy) of young children with burn injuries.
    

Detailed description: 
      1. BACKGROUND 1.1 The burden of burns and pain. Burn injuries are among the leading causes
           of visits to the emergency department and hospitalizations in young children. They
           mostly result from scalds and contact with household appliances. Regardless the cause of
           the injury, dressing changes and hydrotherapy sessions for burn injuries are associated
           with extreme pain. The management of acute pain experienced during hydrotherapy sessions
           in patients with burn injuries, called procedural pain, remains a major challenge for
           healthcare professionals. Pain can have several short term effects on the child on the
           development, mood, sleep, appetite, school performance, anxiety and distress levels. In
           the long term, it can decrease the pain threshold, cause stress disorders, affect social
           behavior and seeking of medical services. In burn injuries, pain is often accompanied by
           great anxiety, which in turn, decreases pain tolerance. To relieve pain and anxiety,
           clinicians usually rely on pharmacological agents via the administration of high doses
           of opioids and anxiolytics. The use of these medications can cause deep sedation in
           children, and many side effects such as nausea, vomiting, and respiratory depression.
           Also, despite the growing use of opioids, patients report pain of more than 7 on a scale
           of 0-10 during their dressing changes and hydrotherapy sessions. Multimodal approaches
           combining medication and non-pharmacological interventions should be explored to reduce
           pain and anxiety associated with painful procedures.

           1.2. Innovation of non-pharmacological pain interventions. Studies and reviews have
           highlighted, in recent years, the effectiveness of multimodal approaches combining
           medication with non-pharmacological interventions for procedural pain relief.
           Distraction techniques have been recognized among the most effective non-pharmacological
           interventions. They divert the child's attention to an attractive element, hindering the
           perception of the painful stimuli and therefore reducing pain and anxiety. Distraction
           is based on the gate control theory of Melzack and Wall stating a link between
           perception of pain and level of attention devoted to the stimulus affecting the painful
           experience. Therefore, distraction techniques engaging multiple senses such as vision
           and audition may grab the child's attention more than the techniques that only engage
           one sense. Hence, the increasing interest in more immersive and interactive methods of
           distraction such as virtual reality (VR) for the management of procedural pain.

           1.3 Virtual reality distraction. This is an active distraction method that allows the
           user to interact with an immersive environment generated by a computer stimulating
           different senses (vision, hearing and sometimes touch). VR allows a mental escape
           through multisensory interaction. Its effect is known to decrease pain and anxiety. In
           the past ten years, VR was tested through different studies with older children and
           adult burn victims. A study by Hoffman et al. in 2007, showed that the percentage of
           reduction in pain by VR was comparable to the reduction resulting from a moderate dose
           of hydromorphone equivalent to what a patient would receive during a burn wound care.
           Yet, the authors state that they believe the best analgesia is achieved by combining VR
           with pharmacological treatment. However, very few studies have tested the effect of a
           combination of pharmacological and virtual reality interventions, on procedural pain and
           anxiety of young children suffering from burn injuries. Also, current studies on VR
           mostly use 3D goggles or helmets in contact or close to the face of the child which
           could be challenging with young children since they mostly have burns on their face and
           upper trunk. Therefore, a new VR prototype has been developed in collaboration with the
           Society of Arts and Technology (SAT) in Montreal to provide an immersive interactive
           experience for the burn child in the hydrotherapy tank. The prototype was developed
           after several meetings between the researchers, the designers and engineers and the
           surgical-trauma team of CHU St. Justine. Meetings were followed by an ergonomic study of
           the hydrotherapy room to meet the unit's and patients' specifications and ensure that it
           doesn't interfere with the healthcare professionals work.

        2. AIM The aim of this pilot study is to assess the feasibility and applicability of the
           prototype as well as the satisfaction of the healthcare professionals regarding the use
           of the VR prototype for the relief of procedural pain and anxiety in young children with
           burn injuries.

           Primary Research Question: In children from 2 months to 10 years old who have suffered
           burn injuries, is VR distraction a feasible, applicable and satisfactory method for pain
           relief during hydrotherapy? Secondary Research Question: In children from 2 months to 10
           years old who have suffered burn injuries, does VR distraction provide better pain and
           anxiety relief during hydrotherapy than standard pharmacological treatment?

        3. HYPOTHESES

             1. VR distraction is a feasible and acceptable non-pharmacological method for
                procedural pain relief (during hydrotherapy) of young children with burn injuries.

             2. VR distraction combined with analgesics is more efficacious than standard treatment
                (analgesics alone) on procedural pain and anxiety (during hydrotherapy) of young
                children with burn injuries.

        4. METHODS 4.1 Design. Single-arm pilot study. 4.2 Sample and Setting. Participants will be
           recruited through convenience sampling upon admission to the surgical-trauma burn unit.
           The unit has a hydrotherapy room for inpatients and outpatients. Healthcare
           professionals usually present during hydrotherapy are: a burn wound care nurse, a nurse
           clinician from the pain clinic, an anesthetist, a physical therapist and an orderly. The
           size of the total desired sample is 15 to 20 participants depending on the recruitment
           rate since it is a pilot study. The study will take place in the hydrotherapy room of
           the CHU St. Justine, a large pediatric university teaching hospital in Montreal where
           the VR prototype is installed.

           4.3. Measures. Measures of baseline pain and anxiety will be recorded at T1, 30 minutes
           before the procedure, in the patient's room. Measures for procedural pain, anxiety and
           sedation level will be taken at: T2, before the procedure, upon arrival in the
           hydrotherapy room, T3, during the procedure (10 min after the beginning of the
           hydrotherapy session), T4, immediately after the procedure before leaving the
           hydrotherapy room and T5, 30 minutes after the procedure in the patient's room. The
           patient's comfort level will also be assessed during the procedure at T3. Finally, the
           acceptability of the intervention will be assessed through a questionnaire comprising
           items on the acceptability and satisfaction of the healthcare professionals at T4. The
           same measures will be recorded for each participant for up to three hydrotherapy
           sessions. The primary outcome will be the acceptability of the intervention. Comparisons
           will be made between pain and anxiety levels for the same order of session.

           4.4 Data analysis plan. Descriptive statistics will be performed for sociodemographic
           and clinical variables, comfort levels and the satisfaction of health professionals.
           Analysis of variance (ANOVA) will be used to compare the mean differences in pain scores
           before, during and after the procedure as well as for anxiety and level of sedation.
           Since the use of rescue medication is a potential indication of a treatment failure, the
           analysis will be supplemented by an analysis comparing the proportion of patients
           receiving rescue medication anytime during the procedure. Interpretation of the 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.

        5. FEASIBILITY The setting of the study is the main referral center for pediatric burns in
           Quebec. It receives nearly 60 admissions during the period when there is a higher
           incidence of burns (April to October) and almost 100 admissions per year. The
           investigators will be able to access the population for the study given the PI's
           affiliation to the research center of this setting. Moreover, stakeholders in the pain
           clinic and surgical-trauma unit are aware of the study, and participated in all stages
           of the prototype development.

        6. POSSIBLE PITFALLS AND SOLUTIONS It is unknown whether the VR is a feasible distraction
           technique in young children/infants aged between 2 months and 2 years old. The pilot
           study will help inform the investigators about the visual tracking in infants during
           painful medical procedures. Upon completion of the pilot study, it will be decided
           whether to include or not the young population in the larger trial.

        7. CONTRIBUTION AND EXPECTED RESULTS Despite growing interest in the field, procedural pain
           management in children remains suboptimal and the importance of developing more
           effective methods is required. This project will provide preliminary evidence on the
           feasibility, acceptability, and preliminary efficacy of non-pharmacological methods of
           procedural pain management through the development and testing of innovative
           interventions. VR distraction could be an interesting method to relieve pain, easy to
           use and without known side effects. The investigators hope that it could reduce the need
           for opioids and anxiolytics in burn children and decrease the pain related to the
           procedures while providing a less traumatizing hospital experience, which is often the
           first for children under 5 years old. The expected results have a direct effect on
           physical (pain, comfort) and psychological (anxiety) health of the child. In addition,
           clinical implications may include other indicators of quality of care and economic
           benefits such as duration of the hydrotherapy session, the amount of opioids and anxiety
           drugs administered, the use of coanalgesics, the number of professionals required in the
           hydrotherapy room and duration of wound healing.
    

Intervention name(s): Virtual Reality Distraction
Intervention type(s): Device
Intervention description(s): VR prototype developed by the SAT will be used as the experimental intervention. It has a wide screen installed at the end of the hydrotherapy tank offering a 150-degree field view, on which appears a game allowing the child to have the immersive entertainment experience without the need to wear a helmet or 3D glasses. The child or a proxy, depending on age and burn site, will have the opportunity to interact with the game. The interactive component is not mandatory for the immersive and distractive experiences provided by the prototype. Video games tailored to the child's age and injury, different from the commercially available ones, will be adapted to each age-group of children recruited with control over the speed of movement to avoid motion sickness.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual reality; Immersive distraction; Virtual world; Virtual environment; Procedural pain; Procedural anxiety; Acute pain; Pain management; Anxiety; Children, Child; Kid, Kids; Pediatric, Pediatrics; Young children; Burns; Burn injuries; Burn unit; Hydrotherapy; Burn dressing; Non-pharmacological; Clinical Research; Nursing Practice