<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/NCT04402216</url>
  </required_header>
  <id_info>
    <org_study_id>20-0098</org_study_id>
    <nct_id>NCT04402216</nct_id>
  </id_info>
  <brief_title>Using Virtual Reality Simulation to Prepare Children Undergoing MRI</brief_title>
  <official_title>Using Virtual Reality Simulation to Prepare Children Undergoing MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Colorado</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Colorado</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>
      This study will evaluate the effectiveness of using virtual reality (VR) to reduce distress&#xD;
      in pediatric patients undergoing MRI scans compared to other methods of preparation. Children&#xD;
      will be divided into four groups. The investigators hypothesize the children who receive&#xD;
      Child Life preparation with VR will experience decreased distress compared to the other 3&#xD;
      treatment groups (no formal preparation, Child Life-led preparation, and MRI preparation&#xD;
      video). The investigators also hypothesize that children who receive Child Life-led&#xD;
      preparation will experience better decreased distress than current standard of care (no&#xD;
      formal preparation) and MRI preparation video.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      II. Background and Significance&#xD;
&#xD;
      MRI scans can be difficult for children due to the confined space inside the MRI scanner, the&#xD;
      loud noises that MRI scanners produce, and the amount of time that it takes to complete the&#xD;
      scan. These factors can lead to a significant amount of distress and anxiety, both for the&#xD;
      child undergoing the MRI scan and his or her family. Several techniques have been developed&#xD;
      to reduce distress and anxiety in children undergoing MRI scans. Child Life Specialists have&#xD;
      been proven to help reduce anxiety in children and better prepare them for MRI scans. Having&#xD;
      a Child Life Specialist integrated into the multidisciplinary team treating a pediatric&#xD;
      patient ensures that the child's emotional needs are being met as much as his or her physical&#xD;
      needs.&#xD;
&#xD;
      Evaluation and intervention from a Child Life Specialist reduce anxiety and allows for&#xD;
      children and families to be better prepared for their MRI, reducing distress of the child&#xD;
      undergoing MRI, and reducing the need for anesthesia. Child life specialists are also able to&#xD;
      utilize medical play using mock scanners and coach children in breathing exercises, such as&#xD;
      blowing bubbles or pinwheels to help children comply with holding their breath during MRI&#xD;
      scans, resulting in clearer images. Child Life specialists play a crucial role in effective&#xD;
      communication with families and the rest of the medical team during and after examination.&#xD;
&#xD;
      III. Preliminary Studies/Progress Report&#xD;
&#xD;
      Another technique that has reduced distress in children during MRI is MRI compatible video&#xD;
      goggles, which allow children to watch videos during the MRI scan. Giving children something&#xD;
      to focus on while inside the MRI machine helps them to stay still and feel less anxious while&#xD;
      still remaining awake. VR is a promising technology that has been used to reduce anxiety and&#xD;
      serve as a pain distraction during intravenous placement required for MRI and CT scans as&#xD;
      well as with children with sickle cell disease managing vaso-occlusive pain episodes. The&#xD;
      inherent immersive and interactive properties of VR games make them effective for pain relief&#xD;
      and distraction and also lends VR to countless potential applications in pediatric&#xD;
      healthcare. KindVR is an independent VR firm that develops VR software specifically for the&#xD;
      use of pediatric patients in a hospital setting. This software has been developed to minimize&#xD;
      significant motion, mitigating risk of motion sickness or nausea, and providing targeted,&#xD;
      age-appropriate content. There is not yet any published evidence that VR can be used to&#xD;
      successfully prepare children for MRI scans, but there is strong evidence that this&#xD;
      technology, especially paired with software specifically designed for use with pediatric&#xD;
      patients in a hospital setting can impact important outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>Anxiety Rating</measure>
    <time_frame>immediately before MRI scan</time_frame>
    <description>Pre-procedural anxiety level of the child will be collected via child self-report and staff report before the MRI scan. Patient and Staff will report child's anxiety using a Visual Analog Scale with anchors &quot;Not Anxious&quot; and &quot;Very Anxious.&quot; VAS scores will range from 1-100, with lower scores indicating less anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visit Satisfaction</measure>
    <time_frame>immediately after MRI scan</time_frame>
    <description>The caregiver will be given a standard Likert scale survey that rates satisfaction in the following areas: overall satisfaction with hospital visit, pain management, respect, and compassion. Guardians will be asked to select between &quot;Very Satisfied,&quot; &quot;Satisfied,&quot; &quot;Neutral,&quot; and &quot;Dissatisfied&quot; in each of the aforementioned areas. The survey will also ask parents to rate teamwork between healthcare professionals and overall quality of care received by selecting a response of &quot;Excellent,&quot; &quot;Fair,&quot; &quot;Neutral,&quot; and &quot;Poor.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic Information</measure>
    <time_frame>collected retrospectively within 24 hours after verbal consent is obtained</time_frame>
    <description>age, ethnicity, gender, type of MRI will be pulled via the electronic medical record retrospectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI Scan Quality</measure>
    <time_frame>immediately after MRI scan</time_frame>
    <description>The MRI Technician will report whether the scan was complete, readable, and if rescanning was needed. Length of the MRI in minutes will be recorded as part of a procedural efficiency measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technician feedback</measure>
    <time_frame>immediately after MRI scan</time_frame>
    <description>A cooperation rating will be collected from the MRI technician after the MRI scan. The technician will report the child's cooperation level using a Visual Analog Scale with anchors of &quot;very uncooperative&quot; and &quot;very cooperative.&quot; VAS scores will range from 1-100, with lower scores indicating less cooperation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Rating</measure>
    <time_frame>immediately after MRI scan</time_frame>
    <description>Post-procedural anxiety level of the child will be collected via child self-report and staff report after the MRI scan. Patient and Staff will report child's anxiety using a Visual Analog Scale with anchors &quot;Not Anxious&quot; and &quot;Very Anxious.&quot; VAS scores will range from 1-100, with lower scores indicating less anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Yale Preoperative Anxiety Scale (m-YPAS) Distress Rating</measure>
    <time_frame>collected while patient is MRI scan</time_frame>
    <description>This structured, observational measure of preoperative anxiety in children consists of 27 items in five domains of behavior (Activity, Emotional Expressivity, State of arousal, Vocalization, and Use of parents). Using Kappa statistics, all m-YPAS domains have good to excellent inter- and intraobserver reliability; when compared with other global behavioral measures of anxiety, the m-YPAS had good validity.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Anxiety</condition>
  <condition>Distress</condition>
  <arm_group>
    <arm_group_label>Current standard of care, no formal preparation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will receive the standard of care with no formal preparation. MRI technologist will meet patient prior to scan introducing role of patient, role of MRI technician, and give verbal discussion of MRI process. MRI technologist will offer opportunity for patient to watch a movie as alternative focus/distraction during MRI scan. The child life specialist will not meet with the caregiver or child during their visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child Life-led preparation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will meet with a child life specialist who will provide psychological preparation utilizing photos, MRI sounds, verbal discussion of MRI process, and discuss various coping strategies such as deep breathing or stress ball and option to watch a movie for alternative focus/distraction during the scan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MRI preparation video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be shown an MRI preparation video by the research coordinator in the MRI dressing room prior to MRI scan. The MRI preparation video will walk the patient through the MRI experience with a mock patient explaining all the steps of MRI process from check in to discharge. The child life specialist will not meet with the caregiver or child during their visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child Life preparation with VR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be provided MRI preparation with a child life specialist using the Kind VR device. The VR (virtual reality) session will consist of an audio and visual MRI experience designed to serve as an opportunity for the patient to practice their scan prior to MRI. The VR session will take place once during the Radiology admission and will be approximately 15 minutes in duration. The VR software was developed by Kind VR and was designed specifically for the purpose of preparation for brain MRI. The interactive VR experience walks patients through each step of an MRI. Patients can practice holding still for the MRI and will get feedback from the VR headset when they are moving their head. Along with VR practice session CCLS will discuss various coping strategies such as deep breathing and/or stress ball and option to watch a movie for alternative focus/distraction during the scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Child Life-led preparation</intervention_name>
    <description>Support from a certified child life specialist in preparation for MRI</description>
    <arm_group_label>Child Life preparation with VR</arm_group_label>
    <arm_group_label>Child Life-led preparation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MRI preparation video</intervention_name>
    <description>A descriptive video about what to expect when undergoing MRI</description>
    <arm_group_label>MRI preparation video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>KindVR Virtual Reality MRI Preparation Experience</intervention_name>
    <description>A VR experience to prepare pediatric patients for MRI, to be used in addition to support from a certified child life specialist</description>
    <arm_group_label>Child Life preparation with VR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) patients aged 6- 17 years who are scheduled for an MRI scan&#xD;
&#xD;
          -  (2) without anesthesia and&#xD;
&#xD;
          -  (3) without contrast.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) cognitive impairment that negates the use of the outcome tools or use of virtual&#xD;
             reality device;&#xD;
&#xD;
          -  (2) visual impairment that could not be corrected by lenses;&#xD;
&#xD;
          -  (3) non-English speaking parent or patient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Claire Simonsen</last_name>
    <phone>720-777-5313</phone>
    <email>Claire.Simonsen@childrenscolorado.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Brianne Newman</last_name>
    <phone>720-777-5413</phone>
    <email>brianne.newman@childrenscolorado.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Simonsen</last_name>
      <phone>720-777-5313</phone>
      <email>Claire.Simonsen@childrenscolorado.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>March 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Colorado</investigator_affiliation>
    <investigator_full_name>Brianne Newman</investigator_full_name>
    <investigator_title>Certified Child Life Specialist</investigator_title>
  </responsible_party>
  <keyword>anxiety</keyword>
  <keyword>distress</keyword>
  <keyword>virtual reality</keyword>
  <keyword>MRI</keyword>
  <keyword>pediatrics</keyword>
  <keyword>child life</keyword>
  <keyword>certified child life specialist</keyword>
  <keyword>VR</keyword>
  <keyword>preparation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IDP will not be shared with other researchers.</ipd_description>
  </patient_data>
  <!-- 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/NCT04402216
org study id: 20-0098
nct id: NCT04402216
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the effectiveness of using virtual reality (VR) to reduce distress
      in pediatric patients undergoing MRI scans compared to other methods of preparation. Children
      will be divided into four groups. The investigators hypothesize the children who receive
      Child Life preparation with VR will experience decreased distress compared to the other 3
      treatment groups (no formal preparation, Child Life-led preparation, and MRI preparation
      video). The investigators also hypothesize that children who receive Child Life-led
      preparation will experience better decreased distress than current standard of care (no
      formal preparation) and MRI preparation video.
II. Background and Significance

      MRI scans can be difficult for children due to the confined space inside the MRI scanner, the
      loud noises that MRI scanners produce, and the amount of time that it takes to complete the
      scan. These factors can lead to a significant amount of distress and anxiety, both for the
      child undergoing the MRI scan and his or her family. Several techniques have been developed
      to reduce distress and anxiety in children undergoing MRI scans. Child Life Specialists have
      been proven to help reduce anxiety in children and better prepare them for MRI scans. Having
      a Child Life Specialist integrated into the multidisciplinary team treating a pediatric
      patient ensures that the child's emotional needs are being met as much as his or her physical
      needs.

      Evaluation and intervention from a Child Life Specialist reduce anxiety and allows for
      children and families to be better prepared for their MRI, reducing distress of the child
      undergoing MRI, and reducing the need for anesthesia. Child life specialists are also able to
      utilize medical play using mock scanners and coach children in breathing exercises, such as
      blowing bubbles or pinwheels to help children comply with holding their breath during MRI
      scans, resulting in clearer images. Child Life specialists play a crucial role in effective
      communication with families and the rest of the medical team during and after examination.

      III. Preliminary Studies/Progress Report

      Another technique that has reduced distress in children during MRI is MRI compatible video
      goggles, which allow children to watch videos during the MRI scan. Giving children something
      to focus on while inside the MRI machine helps them to stay still and feel less anxious while
      still remaining awake. VR is a promising technology that has been used to reduce anxiety and
      serve as a pain distraction during intravenous placement required for MRI and CT scans as
      well as with children with sickle cell disease managing vaso-occlusive pain episodes. The
      inherent immersive and interactive properties of VR games make them effective for pain relief
      and distraction and also lends VR to countless potential applications in pediatric
      healthcare. KindVR is an independent VR firm that develops VR software specifically for the
      use of pediatric patients in a hospital setting. This software has been developed to minimize
      significant motion, mitigating risk of motion sickness or nausea, and providing targeted,
      age-appropriate content. There is not yet any published evidence that VR can be used to
      successfully prepare children for MRI scans, but there is strong evidence that this
      technology, especially paired with software specifically designed for use with pediatric
      patients in a hospital setting can impact important outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anxiety Rating
time frame: immediately before MRI scan
description: Pre-procedural anxiety level of the child will be collected via child self-report and staff report before the MRI scan. Patient and Staff will report child's anxiety using a Visual Analog Scale with anchors "Not Anxious" and "Very Anxious." VAS scores will range from 1-100, with lower scores indicating less anxiety.
measure: Visit Satisfaction
time frame: immediately after MRI scan
description: The caregiver will be given a standard Likert scale survey that rates satisfaction in the following areas: overall satisfaction with hospital visit, pain management, respect, and compassion. Guardians will be asked to select between "Very Satisfied," "Satisfied," "Neutral," and "Dissatisfied" in each of the aforementioned areas. The survey will also ask parents to rate teamwork between healthcare professionals and overall quality of care received by selecting a response of "Excellent," "Fair," "Neutral," and "Poor."
measure: Demographic Information
time frame: collected retrospectively within 24 hours after verbal consent is obtained
description: age, ethnicity, gender, type of MRI will be pulled via the electronic medical record retrospectively
measure: MRI Scan Quality
time frame: immediately after MRI scan
description: The MRI Technician will report whether the scan was complete, readable, and if rescanning was needed. Length of the MRI in minutes will be recorded as part of a procedural efficiency measure.
measure: Technician feedback
time frame: immediately after MRI scan
description: A cooperation rating will be collected from the MRI technician after the MRI scan. The technician will report the child's cooperation level using a Visual Analog Scale with anchors of "very uncooperative" and "very cooperative." VAS scores will range from 1-100, with lower scores indicating less cooperation.
measure: Anxiety Rating
time frame: immediately after MRI scan
description: Post-procedural anxiety level of the child will be collected via child self-report and staff report after the MRI scan. Patient and Staff will report child's anxiety using a Visual Analog Scale with anchors "Not Anxious" and "Very Anxious." VAS scores will range from 1-100, with lower scores indicating less anxiety.
measure: Modified Yale Preoperative Anxiety Scale (m-YPAS) Distress Rating
time frame: collected while patient is MRI scan
description: This structured, observational measure of preoperative anxiety in children consists of 27 items in five domains of behavior (Activity, Emotional Expressivity, State of arousal, Vocalization, and Use of parents). Using Kappa statistics, all m-YPAS domains have good to excellent inter- and intraobserver reliability; when compared with other global behavioral measures of anxiety, the m-YPAS had good validity.
arm group label: Current standard of care, no formal preparation
arm group type: No Intervention
description: Participants in this group will receive the standard of care with no formal preparation. MRI technologist will meet patient prior to scan introducing role of patient, role of MRI technician, and give verbal discussion of MRI process. MRI technologist will offer opportunity for patient to watch a movie as alternative focus/distraction during MRI scan. The child life specialist will not meet with the caregiver or child during their visit.
arm group label: Child Life-led preparation
arm group type: Experimental
description: Participants will meet with a child life specialist who will provide psychological preparation utilizing photos, MRI sounds, verbal discussion of MRI process, and discuss various coping strategies such as deep breathing or stress ball and option to watch a movie for alternative focus/distraction during the scan.
arm group label: MRI preparation video
arm group type: Experimental
description: Participants will be shown an MRI preparation video by the research coordinator in the MRI dressing room prior to MRI scan. The MRI preparation video will walk the patient through the MRI experience with a mock patient explaining all the steps of MRI process from check in to discharge. The child life specialist will not meet with the caregiver or child during their visit.
arm group label: Child Life preparation with VR
arm group type: Experimental
description: Participants will be provided MRI preparation with a child life specialist using the Kind VR device. The VR (virtual reality) session will consist of an audio and visual MRI experience designed to serve as an opportunity for the patient to practice their scan prior to MRI. The VR session will take place once during the Radiology admission and will be approximately 15 minutes in duration. The VR software was developed by Kind VR and was designed specifically for the purpose of preparation for brain MRI. The interactive VR experience walks patients through each step of an MRI. Patients can practice holding still for the MRI and will get feedback from the VR headset when they are moving their head. Along with VR practice session CCLS will discuss various coping strategies such as deep breathing and/or stress ball and option to watch a movie for alternative focus/distraction during the scan.
intervention type: Behavioral
intervention name: Child Life-led preparation
description: Support from a certified child life specialist in preparation for MRI
arm group label: Child Life preparation with VR
arm group label: Child Life-led preparation
intervention type: Behavioral
intervention name: MRI preparation video
description: A descriptive video about what to expect when undergoing MRI
arm group label: MRI preparation video
intervention type: Behavioral
intervention name: KindVR Virtual Reality MRI Preparation Experience
description: A VR experience to prepare pediatric patients for MRI, to be used in addition to support from a certified child life specialist
arm group label: Child Life preparation with VR
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claire Simonsen
phone: 720-777-5313
email: Claire.Simonsen@childrenscolorado.org
last name: Brianne Newman
phone: 720-777-5413
email: brianne.newman@childrenscolorado.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital Colorado
investigator full name: Brianne Newman
investigator title: Certified Child Life Specialist
sharing ipd: No
ipd description: IDP will not be shared with other researchers.