Robot-Based Distraction to Reduce Pain and Distress in the Pediatric Emergency Department
Condition: Children Requiring IV Placement
Study type: Interventional

Summary: 
      Intravenous (IV) insertion is one of the most common procedures for children seeking medical
      treatment in the Emergency Department (ED). This procedure is often painful and distressing
      for children and families. This can result in an uncooperative child, a need for multiple
      cannulation attempts, needle phobia, and dissatisfaction with care for family and healthcare
      workers. Non-pharmacological treatments are emerging as a newly favoured adjunct to
      pharmacotherapy, such as distraction therapy.

      Distraction therapy involves engaging children in cognitive tasks in order to divert
      attention from painful stimuli and reduce pain and distress. Currently, distraction therapy
      is not utilized as a standard of care in the ED. Given children's enthusiasm for
      technological devices, we propose that the use of a technologically enhanced device may be a
      more effective distractor and may have a greater impact on pain reduction outcomes of patient
      importance. The primary objective of this study is to compare the reduction of pain and
      distress with the use of distraction (via the MEDi robot) versus current standard care in
      children aged 6 to 11 years who are undergoing IV placement.
    

Detailed description: 
      Setting and Study Period: This study is a randomized controlled trial and will be conducted
      in the Emergency Department of the Stollery Children's Hospital (SCH). The SCH is a tertiary
      care hospital in Edmonton, Alberta whose annual ED census is >50,000 children. Based on our
      team's previous successful work in this field,12 months of patient recruitment is
      anticipated, and projected to occur from February 2017 to January 2018.

      Study Population: The study will include children aged 6-11 years attending the SCH ED, and
      requiring an IV placement. See Eligibility section for detailed inclusion/ exclusion
      criteria. We plan to recruit 80 patients, overall.

      Recruitment: Research Assistants (RAs) will be on shift from approximately 15:00 to 23:00
      seven days a week. This time corresponds with peak visits requiring IV placements based on
      data collected from previous studies conducted in the SCH ED. RAs will identify and approach
      patients aged 6-11 years who require an IV placement. Inclusion/ exclusion criteria will be
      further assessed, and if the child is eligible, the RA will explain the study and invite the
      parent and child to participate. After obtaining written, informed consent from the parent
      (and assent from the child, if applicable), the RA will randomize the patient into one of two
      study arms and begin data collection. The RA will ask one parent/ caregiver for each child to
      participate and complete all relevant questionnaires.

      Study Assessments: After consent/ assent has been obtained, the RA will collect information
      from the parent on baseline demographic variables (ex. age, gender), presenting signs and
      symptoms (ex. chief complaint), as well as previous history with ED visits and IV placement.
      Before the procedure, the RA will bring the MEDi (Medicine and Engineering Designing
      intelligence) robot into the room for children in the distraction group, set it up, and
      explain how to interact with it. The staff nurse will then perform the routine set up for IV
      placement. Pain will be measured using the child's self-reported scores on the Faces Pain
      Scale Revised (FPS-R). These scores will be collected immediately before and after IV
      placement has occurred. The child's response behaviors to pain will be assessed using the
      Observational Scale of Behavioral Distress (OSBD). The procedure and child will be
      video-taped during IV insertion to complete the OSBD scoring. Parental anxiety will be
      measured pre and post procedure with the State Trait Anxiety Inventory - State Scale Revised
      Version (STAI-S, Form Y). The degree of the child's engagement with the robot will be
      measured immediately following the procedure with the Intrinsic Motivation Inventory (IMI).
      Additionally, vitals will be collected pre, post and during the procedure. Data will be
      entered in real-time into a secure online database hosted on REDCap (Research Electronic Data
      Capture).

      Randomization, Allocation and Blinding of Study Treatment: Randomization will be determined
      using a secure online randomization tool, through REDCap, and hosted via the Clinical
      Research Informatics Core at the University of Alberta. A trained RA will obtain the
      computer-generated randomized assignment after child and parent consent/assent has been
      obtained. Allocation will be concealed from the research staff, ED staff, and participants
      until after consent and randomization has been assigned by computer. Due to the nature of the
      intervention, it will not be possible to blind the children, parents, RAs, or ED staff. The
      children and their parents will be informed that the study is to evaluate different forms of
      distraction but will not know the study hypothesis for the MEDi robot. The data analyst will
      be blind to treatment assignment through the use of randomization codes that will not
      identify groups until analysis is complete.

      Study Intervention and Comparison: The intervention will be the use of the MEDi robot. The
      robot will be at the child's eye level, and will be programmed to introduce itself, interact
      with the child, and make encouraging comments about how brave he/she was. The duration of its
      actions will coincide with the length of the procedure (approximately 5-8 minutes). The
      control group will receive standard care, which generally includes the use of topical
      anesthetic cream. This comparison is based on the pragmatic preferences of physicians at the
      Stollery Children's Hospital as well as precedent in the literature.Overall, it is felt that
      any new intervention (e.g., the MEDi robot) should be compared to what is currently in
      practice (i.e., standard care), as no single distraction therapy is consistently and
      routinely employed in EDs at this time.
    

Intervention name(s): MEDi Robot
Intervention type(s): Device
Intervention description(s): Distraction therapy using an interactive humanoid robot
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain Management; Distraction Therapy; Robot Based Distraction; MEDi