<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/NCT03784352</url>
  </required_header>
  <id_info>
    <org_study_id>H18-03184</org_study_id>
    <nct_id>NCT03784352</nct_id>
  </id_info>
  <brief_title>Virtual Reality Pediatric Orthopaedic Outpatient Procedures</brief_title>
  <acronym>VPRO</acronym>
  <official_title>Virtual Reality in Reducing Pain and Anxiety in Pediatric Orthopaedics, a Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>British Columbia Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>British Columbia Children's Hospital</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>
      The main objective of the study is to evaluate the use of Virtual Reality (VR) in managing&#xD;
      pain and anxiety levels during common pediatric orthopaedic outpatient procedures which&#xD;
      include: cast application, cast removal, hardware removal (ie. pins and screws), and botox&#xD;
      injections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immediately following recruitment, demographic data and diseased related information (ie.&#xD;
      location of cast/hardware, reason for cast/hardware placement and location and reason for&#xD;
      botox injection) will be collected through self and/or guardian report. All data will be&#xD;
      collected using REDCap (research electronic data capture). Using a parallel group design,&#xD;
      patients will then be stratified by age (4-7, 8-12 and 13-18 years), gender, and procedure&#xD;
      classifications (hardware or cast or staple or suture removal or cast application or botox&#xD;
      injection) site of hardware or cast or staple or suture or botox injection), and reason for&#xD;
      the procedure (trauma vs a preexisting orthopaedic condition). After randomization by the&#xD;
      REDCap system, patients are taken into the procedure room where a questionnaire (Short STAI)&#xD;
      is completed by the patient to collect pre-procedural state anxiety measurements. Following&#xD;
      this, patients in the control group will receive standard of care (SOC) which allows for the&#xD;
      technician and/or accompanying guardian to try and distract and or console the patient as&#xD;
      they normally would. The patients in the intervention group will receive SOC with Virtual&#xD;
      Reality (VR) interaction a few minutes before, during and following the procedure (around&#xD;
      5-10minutes total). During the procedure the researcher will complete an observational survey&#xD;
      (CEMS) to assess procedural state anxiety. Upon completion, both groups will then be asked to&#xD;
      complete a survey (Short STAI) to collect post-procedural anxiety levels and an additional&#xD;
      survey (Wong Baker Scale) to retrospectively collect pain levels from during the procedure&#xD;
      and their current pain levels post procedure while parent/guardians and cast technician will&#xD;
      be asked to complete their respective satisfaction questionnaires. Following this, the child&#xD;
      will be asked if they experienced any nausea at any point during the procedure, if they did,&#xD;
      they will be asked to complete the BARF questionnaire to measure the amount of nausea&#xD;
      experienced. Following completion of questionnaires, patients who were in the control group&#xD;
      are invited to interact with the VR simulation for a total of 5 minutes. This was chosen to&#xD;
      incentivize recruitment for the study.&#xD;
&#xD;
      SOC will consist of the technician/care provider explaining the procedure while using speech&#xD;
      to be comforting and supportive in addition to parent/guardians being allowed to console and&#xD;
      distract their child during the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 10, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wong Baker Scale (WBS) for Procedural Pain</measure>
    <time_frame>Immediately post procedure</time_frame>
    <description>The WBS is a self-reported outcome measure that asks patients to rate their pain severity by circling the face that best describes the pain on a horizontally positioned VAS with marked end points of &quot;no pain&quot; and &quot;worst possible pain&quot;. There are six possible faces with &quot;no pain&quot; representing a score of 0 and &quot;worst pain&quot; representing a score of 10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety (state anxiety intraprocedure)</measure>
    <time_frame>Intraprocedure</time_frame>
    <description>Intraprocedural state anxiety will be measured using the The Children's Emotional Manifestation Scale (CEMS) which consists of five categories that include:&#xD;
Facial expression, vocalization, activity, interaction and level of cooperation. A score is obtained by reviewing five descriptions in each category and selecting the number that most clearly represents the observed behavior. Each category is given a score from 1 to 5 for a total score of 5-25. A higher score corresponds to a more distressed child.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural Time</measure>
    <time_frame>Intraprocedure</time_frame>
    <description>Measured with a stopwatch: Start of the procedure defined as the moment the patient completes the first short SAIS, which is shortly upon entering the procedural room. End of the procedure is marked as follows: complete removal of cast (for cast removal), removal of last staple or hardware (staple and hardware removal), removal of needle from final injection site (botox injection)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baxter Retching Faces (BARF) Scale for Nausea</measure>
    <time_frame>Immediately post procedure</time_frame>
    <description>Patients will use the pictorial Baxter Retching Faces Scale (BARF) to measure nausea severity. It is a scale of 0-10 with 6 faces, with the first representing no nausea to the last as experiencing vomiting. This scale has been shown to have construct, content and convergent validity in measuring nausea in children. After the patients have completed the post procedure short SAIS the patients will be asked if they had experienced any feelings of nausea at any point during the procedure. If they answer yes, then they will be asked to rate the nausea using the BARF scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State Anxiety Preprocedure</measure>
    <time_frame>Immediately pre-procedure</time_frame>
    <description>State Anxiety will be measured prior to start of procedure using the Short SAIS (state anxiety inventory scale) which is a shortened version of the Spielberger State Trait Anxiety Inventory (STAI) Scale will be used to collect data on state anxiety. State anxiety refers to the anxiety levels at a particular moment in time. This is in contrast to trait anxiety which is a measure of the tendency of an individual to experience anxiety across different situations. The short SAIS is a six item questionnaire with four possible responses for each item. The total score ranges from 6-24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety. The total time to complete the questionnaire is approximately five minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State Anxiety Postprocedure</measure>
    <time_frame>Immediately post procedure</time_frame>
    <description>State Anxiety will also be measured immediately after completion of the procedure using the Short SAIS (state anxiety inventory scale) which is a shortened version of the Spielberger State Trait Anxiety Inventory (STAI) Scale will be used to collect data on state anxiety. State anxiety refers to the anxiety levels at a particular moment in time. This is in contrast to trait anxiety which is a measure of the tendency of an individual to experience anxiety across different situations. The short SAIS is a six item questionnaire with four possible responses for each item. The total score ranges from 6-24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety. The total time to complete the questionnaire is approximately five minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trait Anxiety</measure>
    <time_frame>Preprocedure while in the waiting area</time_frame>
    <description>The Penn State Worry Questionnaire for Children (PSWQ-C) is a screening tool for assessing generalized anxiety in children aged 7-17 years. It consists of a 14 item self-reported questionnaire. Respondents indicate how often each item applies to them, choosing from the following responses: &quot;never&quot;, &quot;sometimes&quot;, &quot;often&quot;, and &quot;always&quot;, with points ranging from 0 to 3 for each item. The total score ranges from 0 to 42, with higher scores indicating a greater tendency to worry. The total time to complete the questionnaire is approximately five minutes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Anxiety</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Virtual Reality (VR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will consist of standard of care (SOC) in addition to the use of virtual reality. SOC consists of the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure and interacting with other distractions techniques that may be available (ie. ipad, or mobile device) Patients assigned to the VR group will interact with VR through mobile-based VR googles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Virtual Reality (VR)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm will receive regular standard of care (SOC), the same that would be received if they were not enrolled in the study. SOC will include the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure and interacting with other distractions techniques that may be available (ie. ipad, or mobile device)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality</intervention_name>
    <description>A calming virtual reality game will be played</description>
    <arm_group_label>Virtual Reality (VR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  child must be between the ages of 4 and 18 years&#xD;
&#xD;
          -  the parent/guardians and child are both able to speak and read English or have a&#xD;
             translator be present for them&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  symptoms of respiratory or gastrointestinal infection&#xD;
&#xD;
          -  visual, auditory, cognitive impairment or developmental delay&#xD;
&#xD;
          -  history of seizures or epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kishore Mulpuri, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>British Columbia Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>Ontario</state>
        <zip>V6H3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>British Columbia Children's Hospital</investigator_affiliation>
    <investigator_full_name>Bejaan Jivraj</investigator_full_name>
    <investigator_title>Research Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03784352
org study id: H18-03184
nct id: NCT03784352
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of the study is to evaluate the use of Virtual Reality (VR) in managing
      pain and anxiety levels during common pediatric orthopaedic outpatient procedures which
      include: cast application, cast removal, hardware removal (ie. pins and screws), and botox
      injections.
Immediately following recruitment, demographic data and diseased related information (ie.
      location of cast/hardware, reason for cast/hardware placement and location and reason for
      botox injection) will be collected through self and/or guardian report. All data will be
      collected using REDCap (research electronic data capture). Using a parallel group design,
      patients will then be stratified by age (4-7, 8-12 and 13-18 years), gender, and procedure
      classifications (hardware or cast or staple or suture removal or cast application or botox
      injection) site of hardware or cast or staple or suture or botox injection), and reason for
      the procedure (trauma vs a preexisting orthopaedic condition). After randomization by the
      REDCap system, patients are taken into the procedure room where a questionnaire (Short STAI)
      is completed by the patient to collect pre-procedural state anxiety measurements. Following
      this, patients in the control group will receive standard of care (SOC) which allows for the
      technician and/or accompanying guardian to try and distract and or console the patient as
      they normally would. The patients in the intervention group will receive SOC with Virtual
      Reality (VR) interaction a few minutes before, during and following the procedure (around
      5-10minutes total). During the procedure the researcher will complete an observational survey
      (CEMS) to assess procedural state anxiety. Upon completion, both groups will then be asked to
      complete a survey (Short STAI) to collect post-procedural anxiety levels and an additional
      survey (Wong Baker Scale) to retrospectively collect pain levels from during the procedure
      and their current pain levels post procedure while parent/guardians and cast technician will
      be asked to complete their respective satisfaction questionnaires. Following this, the child
      will be asked if they experienced any nausea at any point during the procedure, if they did,
      they will be asked to complete the BARF questionnaire to measure the amount of nausea
      experienced. Following completion of questionnaires, patients who were in the control group
      are invited to interact with the VR simulation for a total of 5 minutes. This was chosen to
      incentivize recruitment for the study.

      SOC will consist of the technician/care provider explaining the procedure while using speech
      to be comforting and supportive in addition to parent/guardians being allowed to console and
      distract their child during the procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Wong Baker Scale (WBS) for Procedural Pain
time frame: Immediately post procedure
description: The WBS is a self-reported outcome measure that asks patients to rate their pain severity by circling the face that best describes the pain on a horizontally positioned VAS with marked end points of "no pain" and "worst possible pain". There are six possible faces with "no pain" representing a score of 0 and "worst pain" representing a score of 10
measure: Anxiety (state anxiety intraprocedure)
time frame: Intraprocedure
description: Intraprocedural state anxiety will be measured using the The Children's Emotional Manifestation Scale (CEMS) which consists of five categories that include:
Facial expression, vocalization, activity, interaction and level of cooperation. A score is obtained by reviewing five descriptions in each category and selecting the number that most clearly represents the observed behavior. Each category is given a score from 1 to 5 for a total score of 5-25. A higher score corresponds to a more distressed child.
measure: Procedural Time
time frame: Intraprocedure
description: Measured with a stopwatch: Start of the procedure defined as the moment the patient completes the first short SAIS, which is shortly upon entering the procedural room. End of the procedure is marked as follows: complete removal of cast (for cast removal), removal of last staple or hardware (staple and hardware removal), removal of needle from final injection site (botox injection)
measure: Baxter Retching Faces (BARF) Scale for Nausea
time frame: Immediately post procedure
description: Patients will use the pictorial Baxter Retching Faces Scale (BARF) to measure nausea severity. It is a scale of 0-10 with 6 faces, with the first representing no nausea to the last as experiencing vomiting. This scale has been shown to have construct, content and convergent validity in measuring nausea in children. After the patients have completed the post procedure short SAIS the patients will be asked if they had experienced any feelings of nausea at any point during the procedure. If they answer yes, then they will be asked to rate the nausea using the BARF scale.
measure: State Anxiety Preprocedure
time frame: Immediately pre-procedure
description: State Anxiety will be measured prior to start of procedure using the Short SAIS (state anxiety inventory scale) which is a shortened version of the Spielberger State Trait Anxiety Inventory (STAI) Scale will be used to collect data on state anxiety. State anxiety refers to the anxiety levels at a particular moment in time. This is in contrast to trait anxiety which is a measure of the tendency of an individual to experience anxiety across different situations. The short SAIS is a six item questionnaire with four possible responses for each item. The total score ranges from 6-24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety. The total time to complete the questionnaire is approximately five minutes.
measure: State Anxiety Postprocedure
time frame: Immediately post procedure
description: State Anxiety will also be measured immediately after completion of the procedure using the Short SAIS (state anxiety inventory scale) which is a shortened version of the Spielberger State Trait Anxiety Inventory (STAI) Scale will be used to collect data on state anxiety. State anxiety refers to the anxiety levels at a particular moment in time. This is in contrast to trait anxiety which is a measure of the tendency of an individual to experience anxiety across different situations. The short SAIS is a six item questionnaire with four possible responses for each item. The total score ranges from 6-24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety. The total time to complete the questionnaire is approximately five minutes.
measure: Trait Anxiety
time frame: Preprocedure while in the waiting area
description: The Penn State Worry Questionnaire for Children (PSWQ-C) is a screening tool for assessing generalized anxiety in children aged 7-17 years. It consists of a 14 item self-reported questionnaire. Respondents indicate how often each item applies to them, choosing from the following responses: "never", "sometimes", "often", and "always", with points ranging from 0 to 3 for each item. The total score ranges from 0 to 42, with higher scores indicating a greater tendency to worry. The total time to complete the questionnaire is approximately five minutes.
arm group label: Virtual Reality (VR)
arm group type: Experimental
description: The intervention will consist of standard of care (SOC) in addition to the use of virtual reality. SOC consists of the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure and interacting with other distractions techniques that may be available (ie. ipad, or mobile device) Patients assigned to the VR group will interact with VR through mobile-based VR googles.
arm group label: No Virtual Reality (VR)
arm group type: No Intervention
description: This arm will receive regular standard of care (SOC), the same that would be received if they were not enrolled in the study. SOC will include the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure and interacting with other distractions techniques that may be available (ie. ipad, or mobile device)
intervention type: Device
intervention name: Virtual Reality
description: A calming virtual reality game will be played
arm group label: Virtual Reality (VR)
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kishore Mulpuri, MBBS
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: British Columbia Children's Hospital
investigator full name: Bejaan Jivraj
investigator title: Research Student
mesh term: Anxiety Disorders
sharing ipd: No