Virtual Reality-based Distraction to Reduce Distress in the Pediatric Emergency Department
Condition: Children Requiring IV Placement
Study type: Interventional

Summary: 
      Needle procedures, such as intravenous (IV) insertions, are among the most commonly performed
      procedures for children needing medical care. IV insertions are often a painful and stressful
      experience for both children and their parents/ caregivers. Pediatric pain and distress that
      is not adequately treated may lead to a frightened and uncooperative child, repeated IV
      attempts and overall frustration with care for the family and clinical team.

      Distraction therapy is a common psychological strategy which involves engaging children in a
      cognitive task or activity in order to divert attention away from painful stimuli. Given
      children's growing enthusiasm for novel technology, the investigators propose that an
      immersive virtual reality (VR) experience may provide an effective means of distraction for
      children undergoing IV insertions.
    

Detailed description: 
      Objectives: The investigators' primary objective is to compare the reduction of distress with
      the use of distraction (via the VR intervention) versus current standard of care in children
      aged 6 to 17 years who are undergoing IV placement. The secondary objectives are to compare
      (a) the reduction of pain; (b) the reduction of fear; (c) the reduction of parental/caregiver
      anxiety; and (d) parental/caregiver and nurse satisfaction with the procedure in the
      intervention versus control arms; and (e) to assess the safety of using VR intervention in
      children aged 6 to17 years who are undergoing IV placement.

      Research Plan: The investigators will conduct a randomized controlled trial consisting of a
      control arm receiving departmental standard of care and an intervention arm which will
      include the addition of an immersive VR experience to current standard of care. Children 6 to
      17 years of age who are undergoing IV insertions in the Stollery Children's Hospital
      emergency department will be considered for enrollment into the study. Approximately 80
      families will be recruited over a one-year period.

      Study Intervention and Comparison: The VR intervention will aim to provide distraction by
      immersing the child in an artificial 3-dimensional environment that will engage them for the
      duration of the IV procedure. The child will wear a head-mounted display ("VR goggles") that
      will allow them to explore the virtual world through their own visual perspective in
      360-degrees. A small handheld controller (optional) can be used to interact with the virtual
      environment and change settings. The VR goggles will occlude the patient's view of the
      treatment room, and a pair of noise-cancelling headphones (optional) can be used to further
      block out ambient hospital sounds. Together, this will provide the child with a unique vivid
      experience of being fully immersed or "present" inside the 3D virtual world. The control
      group will receive departmental standard of care which will include topical anesthetic cream
      (mandatory) and may include parent/caregiver support, child life services, nursing support,
      etc (at the discretion of the ED clinical care team and the family). At present, there is no
      single established distraction therapy or routine that is consistently employed for IV
      procedures within the study site ED. Thus, for pragmatic and ethical considerations, it is
      felt that the new study VR intervention should be compared to what is currently already in
      practice (ie. standard of care). Of note, other forms of technology (e.g. smart phones,
      tablets) will not be prohibited in the control group, if the family chooses to offer them.
      Due to ethical and pragmatic considerations, children in both groups must receive topical
      anesthetic cream for IV placement, as it is known to be effective and considered standard of
      care within the study hospital.

      Study Impact: The use of immersive VR technology has previously shown promise in numerous
      healthcare settings. However, there is still a need for robust evidence regarding its
      effectiveness in treating pediatric distress associated with IV procedures, particularly in
      the emergency department. Results of this randomized controlled trial could inform an
      evidence-based strategy for the management of pediatric distress, which could be used in
      settings with and without child life specialists.
    

Intervention name(s): Virtual Reality Distraction
Intervention type(s): Device
Intervention description(s): Distraction therapy using a Virtual Reality (VR) device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Distress; Virtual Reality; Distraction Therapy