<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/NCT03835390</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00030717</org_study_id>
    <nct_id>NCT03835390</nct_id>
  </id_info>
  <brief_title>SIMDiscovery: The Benefits of Utilizing a Simulation Preparation Program for Spinal Fusion Surgery</brief_title>
  <official_title>SIMDiscovery: The Benefits of Utilizing a Preparation Program With Simulation in Reducing Anxiety and Increasing Preparedness Among Parents and Their Children Undergoing Spinal Fusion Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston 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>
      This is a pilot study aiming to examine preliminary effectiveness of a preparation program&#xD;
      which includes simulation (SIMDiscovery) in reducing anxiety and increasing feelings of&#xD;
      preparedness among parents and their children who will undergo spinal fusion surgery.&#xD;
      SIMDiscovery is an experiential learning preparation program which aims to educate children&#xD;
      and families about different medical procedures through simulation play.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2019</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 9, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Parent's and Adolescent's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>Parent and adolescent anxiety will be measured at baseline utilizing the State/Trait Anxiety Inventory (STAI) (Spielberger et al., 1983). The STAI consists of 40 items total-20 items assessing trait anxiety (general proneness to anxious behavior) and 20 items assessing state anxiety (a current emotional state). All items are scored using a four-point scale (e.g., ranging from &quot;Almost Never&quot; to &quot;Almost Always&quot;). Scores can range from 20 to 80 with higher scores indicating greater anxiety. This measure has been validated for use with individuals ages 15 and above (Julian, 2011). If a patient is 15 years of age or above, they will complete the STAI, rather than the STAIC (see below).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Child's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory for Children</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>Child anxiety will be assessed utilizing the State/Trait Anxiety Inventory for Children (STAIC) (Spielberger &amp; Edwards, 1973). Similar to the STAI, the STAIC consists of 20 items assessing state anxiety and 20 items assessing trait anxiety. Items are scored using a four-point scale and higher scores indicate greater anxiety. The STAIC has been validated for use with children up to age 15 years (Spielberger &amp; Edwards, 1973).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Parent's Baseline Feelings of Preparedness at 1 month using Caregiver Preparedness Scale</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>Parent preparedness will be measured using the Caregiver Preparedness Scale (CPS) (Archbold, et al., 1990). This scale has been validated for use with adult caregivers (Petruzzo et al., 2017; Pucciarelli et al., 2014). The CPS includes eight items assessing caregiver preparedness to care for a patient's physical and emotional needs, setting up services, coping with the stress of caregiving, making caregiving activities pleasant for the caregiver and patient, responding and managing emergencies, obtaining assistance from the health care system, and overall preparedness. Each item is rated from 0 (not at all prepared) to 4 (Very well prepared). Items are summed for a total score that ranges from 0 to 32, with higher scores indicating feeling better prepared for the caregiving role.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Child's Baseline Feelings of Preparedness at 1 month using a modified Caregiver Preparedness Scale</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>In order to examine themes similar to parent preparedness but from the patient's perspective, we will administer a measure similar to the CPS (above) for children and adolescent patients. This measure has not been validated; rather, based on the validity of the CPS used to assess parent preparedness, we modified the measure to assess patients' perception of their ability to care for or advocate for themselves regarding their physical and emotional needs prior to the surgery. (Archbold, et al., 1990). All patients will complete this measure. This measure consists of six questions and similar to the CPS, each item is rated from 0 (not at all prepared) to 4 (Very well prepared). Items are summed for a total score that ranges from 0 to 24, with higher scores indicating more feelings of preparedness for the surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge of Perioperative Procedures measured by Spinal Fusion Knowledge Assessment</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>Facts that patients learn through the preoperative appointment and the SIMDiscovery program measured by the Spine Fusion Knowledge Assessment developed by our team</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Scoliosis Idiopathic Adolescent</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who agree to participate in the SIMDiscovery program will be asked if they would like to participate in the research. If they consent, they will fill out pre- and post-questionnaires concerning quality of life, anxiety levels concerning the surgery, and a knowledge assessment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SIMDiscovery</intervention_name>
    <description>The SIMDiscovery program consists of nine stations that were designed to mirror the different stages of the perioperative process. The stations mirror the different stages of the surgical process and provide patients and their families with education regarding what they can anticipate during each aspect of the intervention.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and adolescents with adolescent idiopathic scoliosis and their parent(s)&#xD;
&#xD;
          -  Spinal fusion surgery scheduled&#xD;
&#xD;
          -  Developmental Age range (10+; no upper age range)&#xD;
&#xD;
          -  Males and females of all races and ethnicities&#xD;
&#xD;
          -  English-speaking families (although English need not be their primary language)&#xD;
&#xD;
          -  Both patient and caregiver (when patient is under 18 years of age) are able to attend&#xD;
             SIMDiscovery program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Other significant chronic medical conditions (e.g., spina bifida, muscular&#xD;
             dystrophy)&#xD;
&#xD;
          -  Anterior surgical access&#xD;
&#xD;
          -  ICU stay expected post-op&#xD;
&#xD;
          -  Cognitive functioning level below 10yo&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Hedequist, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lauren Potthoff, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Daniel Hedequist</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Preparedness</keyword>
  <keyword>Spinal Fusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</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/NCT03835390
org study id: IRB-P00030717
nct id: NCT03835390
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pilot study aiming to examine preliminary effectiveness of a preparation program
      which includes simulation (SIMDiscovery) in reducing anxiety and increasing feelings of
      preparedness among parents and their children who will undergo spinal fusion surgery.
      SIMDiscovery is an experiential learning preparation program which aims to educate children
      and families about different medical procedures through simulation play.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Parent's and Adolescent's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory
time frame: Baseline, 1 month
description: Parent and adolescent anxiety will be measured at baseline utilizing the State/Trait Anxiety Inventory (STAI) (Spielberger et al., 1983). The STAI consists of 40 items total-20 items assessing trait anxiety (general proneness to anxious behavior) and 20 items assessing state anxiety (a current emotional state). All items are scored using a four-point scale (e.g., ranging from "Almost Never" to "Almost Always"). Scores can range from 20 to 80 with higher scores indicating greater anxiety. This measure has been validated for use with individuals ages 15 and above (Julian, 2011). If a patient is 15 years of age or above, they will complete the STAI, rather than the STAIC (see below).
measure: Change from Child's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory for Children
time frame: Baseline, 1 month
description: Child anxiety will be assessed utilizing the State/Trait Anxiety Inventory for Children (STAIC) (Spielberger & Edwards, 1973). Similar to the STAI, the STAIC consists of 20 items assessing state anxiety and 20 items assessing trait anxiety. Items are scored using a four-point scale and higher scores indicate greater anxiety. The STAIC has been validated for use with children up to age 15 years (Spielberger & Edwards, 1973).
measure: Change from Parent's Baseline Feelings of Preparedness at 1 month using Caregiver Preparedness Scale
time frame: Baseline, 1 month
description: Parent preparedness will be measured using the Caregiver Preparedness Scale (CPS) (Archbold, et al., 1990). This scale has been validated for use with adult caregivers (Petruzzo et al., 2017; Pucciarelli et al., 2014). The CPS includes eight items assessing caregiver preparedness to care for a patient's physical and emotional needs, setting up services, coping with the stress of caregiving, making caregiving activities pleasant for the caregiver and patient, responding and managing emergencies, obtaining assistance from the health care system, and overall preparedness. Each item is rated from 0 (not at all prepared) to 4 (Very well prepared). Items are summed for a total score that ranges from 0 to 32, with higher scores indicating feeling better prepared for the caregiving role.
measure: Change from Child's Baseline Feelings of Preparedness at 1 month using a modified Caregiver Preparedness Scale
time frame: Baseline, 1 month
description: In order to examine themes similar to parent preparedness but from the patient's perspective, we will administer a measure similar to the CPS (above) for children and adolescent patients. This measure has not been validated; rather, based on the validity of the CPS used to assess parent preparedness, we modified the measure to assess patients' perception of their ability to care for or advocate for themselves regarding their physical and emotional needs prior to the surgery. (Archbold, et al., 1990). All patients will complete this measure. This measure consists of six questions and similar to the CPS, each item is rated from 0 (not at all prepared) to 4 (Very well prepared). Items are summed for a total score that ranges from 0 to 24, with higher scores indicating more feelings of preparedness for the surgery.
measure: Knowledge of Perioperative Procedures measured by Spinal Fusion Knowledge Assessment
time frame: Baseline, 1 month
description: Facts that patients learn through the preoperative appointment and the SIMDiscovery program measured by the Spine Fusion Knowledge Assessment developed by our team
arm group label: Intervention
arm group type: Experimental
description: Participants who agree to participate in the SIMDiscovery program will be asked if they would like to participate in the research. If they consent, they will fill out pre- and post-questionnaires concerning quality of life, anxiety levels concerning the surgery, and a knowledge assessment.
intervention type: Behavioral
intervention name: SIMDiscovery
description: The SIMDiscovery program consists of nine stations that were designed to mirror the different stages of the perioperative process. The stations mirror the different stages of the surgical process and provide patients and their families with education regarding what they can anticipate during each aspect of the intervention.
arm group label: Intervention
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Daniel Hedequist, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Lauren Potthoff, PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Daniel Hedequist
investigator title: Principle Investigator
mesh term: Scoliosis
sharing ipd: No