Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department
Condition: IV Insertion in the Emergency Department
MeSH terms: Emergencies; Pain, Procedural
Study type: Interventional

Summary: 
      Venipuncture and intravenous (IV) access continue to be the most common causes of pain and
      distress among children in the pediatric emergency department. Virtual reality has been
      successful for reducing pain and fear in many clinical scenarios, including port access in
      oncology patients, anxiety disorders, phobias, burn and wound care and others. There is only
      one previous study examining virtual reality distraction to reduce procedural pain during IV
      insertion in pediatric patients and no previous studies examining this in the emergency
      department setting. In this study, the investigators will compare immersive virtual reality
      (an interactive underwater environment) to the current standard (tablet device/iPad playing a
      movie) for distraction to reduce procedural pain during IV insertion. The investigators
      hypothesize that the immersive quality of the virtual reality will reduce patient's pain
      scores, fear scores and tachycardia during and after the procedure, and have minimal effect
      on departmental flow and nursing satisfaction. If this feasibility pilot study yields
      positive results, the investigators plan to expand to a larger randomized control trial.
    

Detailed description: 
      This study is a pilot randomized control trial that aims to (a) to determine the differences
      in self-reported and proxy-reported pain and fear during IV insertion between the interactive
      VR intervention and control group, and (b) to assess the feasibility (safety, acceptability)
      of the VR intervention to children/families and the healthcare team in the pediatric
      emergency department. The study will consist of two study arms, where both study arms will be
      screened and recruited using the same procedure. Participants will be randomized into either
      (1) Control group: child life specialist plays an age-appropriate video on a tablet device,
      or (2) Intervention (VR Distraction): child life specialist facilitates immersive VR
      experience. Both the intervention and control groups will receive standard medical care
      (e.g., topical anesthetics). A convenience sample of 80 children and adolescents with cancer
      (40 participants per treatment arm; 20 boys and 20 girls per treatment arm) will be
      recruited. In addition to usual care, children in the experimental condition will wear the VR
      headset plus headphones. In the control condition, children will watch a video (i.e., an
      age-appropriate video selected by an emergency department affiliated child life specialist)
      on an iPad, while wearing the same headphones as in the experimental condition.
      Implementation outcomes include accrual and retention rates, acceptability and technical
      difficulties. Effectiveness outcomes include child pain, distress, and fear, as well as
      parent distress.
    

Intervention name(s): Virtual Reality Program; iPad Tablet
Intervention type(s): Device; Device
Intervention description(s): VR with head mounted display (HMD) and headphones.; iPad with headphones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment