MEDi Robot for Pain Management at Induction
Condition: Cognitive Therapy
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a preparation teaching intervention before IV
      insertion, taught by MEDi to children and their parents, will lead to lower levels of
      expected and experienced pain and fear and less distressing pain memories, as compared to
      children who receive standard care. In addition, it will be examined whether this preparation
      intervention will lead to greater parental self-efficacy, less anxiety, and less distressing
      pain memories as compared to controls.
    

Detailed description: 
      The primary aim is to determine the impact of using a humanoid robot in comparison to
      standard care. This proposal describes the first study in the world to test such novel
      technology for preparation teaching intervention before IV insertion. This work builds on
      previous research conducted by the research team and represents a logical next step for this
      collaborative group. This project team includes established and emerging leaders in pain
      management research. This will ensure successful implementation and completion of the
      project. These methods of teaching preparation have the potential for widespread application
      to other medical procedures and clinical settings (eg. oncology dentistry) and lead to
      improved health outcomes for children by easing their suffering and improving the quality of
      their healthcare encounters.

      1.2 Research Questions

      Research Question 1.) Does preparation administered by a humanoid robot (MEDi) reduce
      expectancies and experience of pain and fear of IV insertion in children?

      Hypothesis 1.) Children who receive preparation by MEDi will report expecting and
      experiencing lower levels of fear and pain at IV insertion as compared to youth receiving
      standard care.

      Research Question 2.) Does preparation administered by MEDi lead to higher self-efficacy and
      lower anxiety in parents of children undergoing IV insertion?

      Hypothesis 2.) Parents of children who receive preparation by MEDi will report higher levels
      of self-efficacy and lower anxiety at their children's IV insertion as compared to youth
      receiving standard care.

      Research Question 3.) Do children who receive preparation administered by MEDi and their
      parents have more accurate and positively estimated memories of pain and fear as compared to
      youth receiving standard care and their parents?

      Hypothesis 3.) Children who receive preparation administered by MEDi and their parents will
      report more accurate and positively estimated memories of pain and fear as compared to youth
      receiving standard care and their parents.

      Research Question 4.) Do children who receive preparation administered by MEDi prior to IV
      insertion and their parents expect to experience less pain, fear, anxiety, and higher
      self-efficacy in pain coping at future needle procedures as compared to youth receiving
      standard care and their parents?

      Hypothesis 4.) Children who receive preparation administered by MEDi prior to IV insertion
      and their parents will report expecting to experience lower pain, fear, and anxiety and
      higher self-efficacy in pain coping at future needle procedures as compared to youth
      receiving standard care and their parents.

      2.1 Study Design & Setting

      This study is a single-centre prospective randomized, controlled, two-armed trial: (1)
      humanoid robot, MEDi, provides preparation for intravenous placement; and (2) standard care.
      Patients will be recruited from day surgery at the Alberta Children's Hospital Calgary, AB.
      This study will follow the high methodological standards for reporting RCTs according to the
      Consolidated Standards of Reporting Trials guidelines - extension for nonpharmacological
      treatments and this trial will be registered with clinicaltrials.gov.

      2.2. Study Population

      Legal guardians and/or patients with the ability to understand the study will be asked to
      provide written informed consent prior to participation. Day surgery patients, between the
      ages of 4-12 years old who are presenting for general surgery under general anesthesia, and
      in the American Society of Anesthesiologists class 1 or 2, will be included.
    

Intervention name(s): Humanoid Robot MEDi
Intervention type(s): Device
Intervention description(s): Humanoid robot programmed with cognitive-behavioral interventions such as role modeling, teaching coping strategies, positive reinforcement, parent encouragement
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cognitive Behavioral Support provided by Robot