Robots to Reduce Pain During IV Placement
Condition: Pain; Anxiety
Study type: Interventional

Summary: 
      Peripheral intravenous catheters (IVs) are utilized in the majority of hospitalized children.
      The placement of IVs requires significant staff time, contributes to health care costs, and
      causes pain and distress in the patients receiving them. Techniques currently used at
      Children's Hospital Los Angeles (CHLA) to reduce children's anxiety and increase success of
      IV placement center depends on members of the Child Life Department distracting patients
      during insertion. Recent literature has suggested that humanoid robots can be a powerful form
      of distraction and lead to decreased pain during painful procedures in children. Work done by
      the University of Southern California (USC) Interaction Lab has shown that socially assistive
      robots can use techniques more complex than pure distraction to lead to a human-robot
      interaction that is perceived as more positive by the human. The investigators propose a
      project pairing children receiving an IV with either a (1) Child Life staff member only (2)
      pure distraction robot + Child Life or (3) an robot teaching coping skills + Child Life with
      a goal of reduced pain. Pain will be measured by participant self-report, family member
      perceived pain, parasympathetic activation, and pain behaviors as measured by video.
    

Detailed description: 
      At USC University Park, computer science collaborators have programmed the robot to speak the
      script which will be used for interaction with participants (see additional supporting
      documents).

      At CHLA, patients arriving to the radiology suite for IV placement prior to MRI and utilizing
      Child Life Services will be approached and consented for inclusion. No participant will
      receive a IV purely for the purpose of the study; only participants already ordered to
      receive IV by the medical team will be included. After consent participants will be
      randomized in blocks using a random-condition generating document to one of three test
      conditions: (1) control, with the usual distraction services provided by one of the
      hospital's child life specialists (2) usual child life + non-coping robot or (2) usual child
      life + coping robot.

      Prior to the procedure participant's parent (or legal guardian) will complete a short survey
      related to pain with previous IV insertions, anxiety related to procedures, and attitudes
      toward robots. Participant's parent/guardian will also complete a validated measure of child
      temperament. Participants will complete a baseline measure of their temperament. Participants
      will then rate current level of pain using the Wong-Baker FACES scale. Participant's anxiety
      level will be assessed using the Children's Fear Scale. Participant's baseline heart rate and
      blood pressure is recorded.

      The IV placement itself will be video recorded for all conditions. Independent assessors not
      aware of the research aims will review the tape to score measures of the strength of
      robot-child interaction and pain behaviors. One research team member will record the number
      of attempts needed to place the IV. A trained research team member will be responsible for
      operating the robot if randomized to that condition.

      The robot used is the MAKI - an open-source 3D printable robot designed by Hello Robo Inc.
      The company has not provided any funding to this project. During the interaction the robot
      will speak in a child-like, gender neutral voice. It will ask short questions of participants
      and have pre-recorded response options (see MAKI script in supporting documents).
      Participants will interact with either child life or the robot by touching tablets. This is a
      minimum risk study, similar to the risk involved in watching a video on a screen. The robot
      is small and only moves its facial features, participants are not touching it.

      Pre- and post-intervention participants will repeat the FACES and Fear Scales. The
      participant and parent/guardian will then be given a short post-survey regarding thoughts on
      the utility of the interaction and the amount of the participant's pain. Heart rate will be
      monitored continuously throughout the interaction. Videos will be evaluated using the
      modified Yale Preoperative Anxiety Index and The Child-Adult Medical Procedure Interaction
      Scale-Short Form (CAMPIS-SF).
    

Intervention name(s): Coping Robot; Non-coping Robot
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Socially assistive robot "MAKI" will interact with children via tablet game designed to teach coping skills.; Socially assistive robot "MAKI" will interact with children via tablet game designed to be distraction only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: intravenous line; robot