<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02997631</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00068199</org_study_id>
    <nct_id>NCT02997631</nct_id>
  </id_info>
  <brief_title>Robot-Based Distraction to Reduce Pain and Distress in the Pediatric Emergency Department</brief_title>
  <official_title>A Randomized Controlled Trial of Humanoid Robot-Based Distraction for Venipuncture Pain: The MEDi Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intravenous (IV) insertion is one of the most common procedures for children seeking medical&#xD;
      treatment in the Emergency Department (ED). This procedure is often painful and distressing&#xD;
      for children and families. This can result in an uncooperative child, a need for multiple&#xD;
      cannulation attempts, needle phobia, and dissatisfaction with care for family and healthcare&#xD;
      workers. Non-pharmacological treatments are emerging as a newly favoured adjunct to&#xD;
      pharmacotherapy, such as distraction therapy.&#xD;
&#xD;
      Distraction therapy involves engaging children in cognitive tasks in order to divert&#xD;
      attention from painful stimuli and reduce pain and distress. Currently, distraction therapy&#xD;
      is not utilized as a standard of care in the ED. Given children's enthusiasm for&#xD;
      technological devices, we propose that the use of a technologically enhanced device may be a&#xD;
      more effective distractor and may have a greater impact on pain reduction outcomes of patient&#xD;
      importance. The primary objective of this study is to compare the reduction of pain and&#xD;
      distress with the use of distraction (via the MEDi robot) versus current standard care in&#xD;
      children aged 6 to 11 years who are undergoing IV placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Setting and Study Period: This study is a randomized controlled trial and will be conducted&#xD;
      in the Emergency Department of the Stollery Children's Hospital (SCH). The SCH is a tertiary&#xD;
      care hospital in Edmonton, Alberta whose annual ED census is &gt;50,000 children. Based on our&#xD;
      team's previous successful work in this field,12 months of patient recruitment is&#xD;
      anticipated, and projected to occur from February 2017 to January 2018.&#xD;
&#xD;
      Study Population: The study will include children aged 6-11 years attending the SCH ED, and&#xD;
      requiring an IV placement. See Eligibility section for detailed inclusion/ exclusion&#xD;
      criteria. We plan to recruit 80 patients, overall.&#xD;
&#xD;
      Recruitment: Research Assistants (RAs) will be on shift from approximately 15:00 to 23:00&#xD;
      seven days a week. This time corresponds with peak visits requiring IV placements based on&#xD;
      data collected from previous studies conducted in the SCH ED. RAs will identify and approach&#xD;
      patients aged 6-11 years who require an IV placement. Inclusion/ exclusion criteria will be&#xD;
      further assessed, and if the child is eligible, the RA will explain the study and invite the&#xD;
      parent and child to participate. After obtaining written, informed consent from the parent&#xD;
      (and assent from the child, if applicable), the RA will randomize the patient into one of two&#xD;
      study arms and begin data collection. The RA will ask one parent/ caregiver for each child to&#xD;
      participate and complete all relevant questionnaires.&#xD;
&#xD;
      Study Assessments: After consent/ assent has been obtained, the RA will collect information&#xD;
      from the parent on baseline demographic variables (ex. age, gender), presenting signs and&#xD;
      symptoms (ex. chief complaint), as well as previous history with ED visits and IV placement.&#xD;
      Before the procedure, the RA will bring the MEDi (Medicine and Engineering Designing&#xD;
      intelligence) robot into the room for children in the distraction group, set it up, and&#xD;
      explain how to interact with it. The staff nurse will then perform the routine set up for IV&#xD;
      placement. Pain will be measured using the child's self-reported scores on the Faces Pain&#xD;
      Scale Revised (FPS-R). These scores will be collected immediately before and after IV&#xD;
      placement has occurred. The child's response behaviors to pain will be assessed using the&#xD;
      Observational Scale of Behavioral Distress (OSBD). The procedure and child will be&#xD;
      video-taped during IV insertion to complete the OSBD scoring. Parental anxiety will be&#xD;
      measured pre and post procedure with the State Trait Anxiety Inventory - State Scale Revised&#xD;
      Version (STAI-S, Form Y). The degree of the child's engagement with the robot will be&#xD;
      measured immediately following the procedure with the Intrinsic Motivation Inventory (IMI).&#xD;
      Additionally, vitals will be collected pre, post and during the procedure. Data will be&#xD;
      entered in real-time into a secure online database hosted on REDCap (Research Electronic Data&#xD;
      Capture).&#xD;
&#xD;
      Randomization, Allocation and Blinding of Study Treatment: Randomization will be determined&#xD;
      using a secure online randomization tool, through REDCap, and hosted via the Clinical&#xD;
      Research Informatics Core at the University of Alberta. A trained RA will obtain the&#xD;
      computer-generated randomized assignment after child and parent consent/assent has been&#xD;
      obtained. Allocation will be concealed from the research staff, ED staff, and participants&#xD;
      until after consent and randomization has been assigned by computer. Due to the nature of the&#xD;
      intervention, it will not be possible to blind the children, parents, RAs, or ED staff. The&#xD;
      children and their parents will be informed that the study is to evaluate different forms of&#xD;
      distraction but will not know the study hypothesis for the MEDi robot. The data analyst will&#xD;
      be blind to treatment assignment through the use of randomization codes that will not&#xD;
      identify groups until analysis is complete.&#xD;
&#xD;
      Study Intervention and Comparison: The intervention will be the use of the MEDi robot. The&#xD;
      robot will be at the child's eye level, and will be programmed to introduce itself, interact&#xD;
      with the child, and make encouraging comments about how brave he/she was. The duration of its&#xD;
      actions will coincide with the length of the procedure (approximately 5-8 minutes). The&#xD;
      control group will receive standard care, which generally includes the use of topical&#xD;
      anesthetic cream. This comparison is based on the pragmatic preferences of physicians at the&#xD;
      Stollery Children's Hospital as well as precedent in the literature.Overall, it is felt that&#xD;
      any new intervention (e.g., the MEDi robot) should be compared to what is currently in&#xD;
      practice (i.e., standard care), as no single distraction therapy is consistently and&#xD;
      routinely employed in EDs at this time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2017</start_date>
  <completion_date type="Actual">May 13, 2018</completion_date>
  <primary_completion_date type="Actual">May 13, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain of IV insertion</measure>
    <time_frame>&lt;5 minutes before IV placement, and immediately after IV placement</time_frame>
    <description>Pain scores will be self-reported by the child on the Faces Pain Scale-Revised (FPS-R)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distress associated with IV insertion</measure>
    <time_frame>During continuous 15-second intervals before, during, and after the IV placement procedure. Approximately 5 minutes before and after the procedure will be captured.</time_frame>
    <description>Two RAs will independently observe a videotape of each child and use the Observational Scale of Behavioral Distress (OSBD) to assess children's response behaviors to pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parental anxiety</measure>
    <time_frame>Immediately before and after IV placement</time_frame>
    <description>Measured with the State Trait Anxiety Inventory - State Scale Revised Version (STAI-S, Form Y), a validated and commonly used version of STAI, which has improved psychometric properties</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of child's engagement with robot</measure>
    <time_frame>Approximately 2-5 minutes after IV placement</time_frame>
    <description>To determine a child's degree of engagement with the robotic technology, children, parents, and nurses will complete the 18-item version of the Intrinsic Motivation Inventory</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Children Requiring IV Placement</condition>
  <arm_group>
    <arm_group_label>MEDi Distraction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MEDi Robot</intervention_name>
    <description>Distraction therapy using an interactive humanoid robot</description>
    <arm_group_label>MEDi Distraction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  6 to 11 years of age&#xD;
&#xD;
          -  Needs an IV placement&#xD;
&#xD;
          -  Fully conscious and alert&#xD;
&#xD;
          -  Has sufficient knowledge of the English language to understand and complete the pain&#xD;
             assessments&#xD;
&#xD;
          -  Accompanied by a legal guardian.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hearing or visual impairments&#xD;
&#xD;
          -  Neurocognitive delays&#xD;
&#xD;
          -  Sensory impairment to pain (e.g., spina bifida)&#xD;
&#xD;
          -  Previous enrollment in the same study&#xD;
&#xD;
          -  Other exclusion at the discretion of the clinical staff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samina Ali, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta/Stollery Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stollery Children's Hospital Emergency Department</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>May 23, 2018</last_update_submitted>
  <last_update_submitted_qc>May 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain Management</keyword>
  <keyword>Distraction Therapy</keyword>
  <keyword>Robot Based Distraction</keyword>
  <keyword>MEDi</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02997631
org study id: Pro00068199
nct id: NCT02997631
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain of IV insertion
time frame: <5 minutes before IV placement, and immediately after IV placement
description: Pain scores will be self-reported by the child on the Faces Pain Scale-Revised (FPS-R)
measure: Distress associated with IV insertion
time frame: During continuous 15-second intervals before, during, and after the IV placement procedure. Approximately 5 minutes before and after the procedure will be captured.
description: Two RAs will independently observe a videotape of each child and use the Observational Scale of Behavioral Distress (OSBD) to assess children's response behaviors to pain.
measure: Parental anxiety
time frame: Immediately before and after IV placement
description: Measured with the State Trait Anxiety Inventory - State Scale Revised Version (STAI-S, Form Y), a validated and commonly used version of STAI, which has improved psychometric properties
measure: Degree of child's engagement with robot
time frame: Approximately 2-5 minutes after IV placement
description: To determine a child's degree of engagement with the robotic technology, children, parents, and nurses will complete the 18-item version of the Intrinsic Motivation Inventory
arm group label: MEDi Distraction
arm group type: Experimental
description: 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).
arm group label: Standard Care
arm group type: No Intervention
description: 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 type: Device
intervention name: MEDi Robot
description: Distraction therapy using an interactive humanoid robot
arm group label: MEDi Distraction
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
last name: Samina Ali, MD
role: Principal Investigator
affiliation: University of Alberta/Stollery Children's Hospital
facility: 
country: Canada
responsible party type: Sponsor