<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/NCT03755687</url>
  </required_header>
  <id_info>
    <org_study_id>AAAS3531</org_study_id>
    <nct_id>NCT03755687</nct_id>
  </id_info>
  <brief_title>Art Therapy Pain Management Adolescents Pediatric ED</brief_title>
  <official_title>Effectiveness of Art Therapy Interventions for Adolescent Pain Management in the Pediatric Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Art Therapy Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</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 project is studying adolescents between the ages of 12 to 18 years that come to the&#xD;
      emergency department and are in pain. We want to find out how well art therapy is able to&#xD;
      decrease the pain they are experiencing. Art therapy will involve making art and working with&#xD;
      an art therapist to find new ways of expressing thoughts and feelings through art making.&#xD;
&#xD;
      In adolescents presenting to the emergency department with a painful condition, our aims are&#xD;
      as follows:&#xD;
&#xD;
      Aim #1: To determine the degree that art therapy intervention reduces pain and anxiety.&#xD;
&#xD;
      Aim #2: To determine the degree that art therapy reduces pain and anxiety 1 hour after the&#xD;
      intervention.&#xD;
&#xD;
      Aim #3: To explore the qualitative experience of patients undergoing art therapy&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain is one of the most common reasons for patients to visit the emergency department (ED),&#xD;
      and can be treated using both complementary and pharmacological strategies. However, children&#xD;
      are often undertreated for pain which results in not only short term problems, but long term&#xD;
      consequences such as trauma and stress-induced disorders; health care avoidance as adults;&#xD;
      increased pain sensitivity; and decreased response to future analgesia. There have been&#xD;
      variable efforts made to improve the ED management of pain in children, but adolescents are&#xD;
      frequently overlooked. A review of the literature revealed that art therapy for pain&#xD;
      management in adolescents is understudied. The majority of studies describe the effects of&#xD;
      art therapy on the emotional well-being in surgical and oncology populations in adults and&#xD;
      children. The studies that did evaluate the effectiveness of art therapy for pain management&#xD;
      in children focused primarily on surgical and medical oncology populations with children aged&#xD;
      2-14 years. Of these studies, none evaluated adolescents in the ED, which is a high volume&#xD;
      and high stress environment that confers a distinct experience for patients compared to other&#xD;
      medical settings. Evaluation of art therapy interventions using quantitative self-report&#xD;
      measures with strong validity in children and further delineation of the patient experience&#xD;
      related to art therapy is necessary. Advanced evaluation of aforementioned interventions&#xD;
      would expand the evidence base needed to describe effectiveness of these interventions and&#xD;
      support greater implementation and dissemination. These are the gaps in knowledge that the&#xD;
      investigators aim to fill with the proposed study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2019</start_date>
  <completion_date type="Actual">November 19, 2021</completion_date>
  <primary_completion_date type="Actual">November 19, 2021</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>
    <intervention_model_description>Prospective observational pilot study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in patient pain intensity: Verbal Numerical Rating Scale</measure>
    <time_frame>1 hour</time_frame>
    <description>Pain intensity measured using the Verbal Numerical Rating Scale. Minimum score (no pain) = 0, maximum score (most/worst pain) = 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient anxiety: Short Form STAI</measure>
    <time_frame>1 hour</time_frame>
    <description>Anxiety measured using the short form State-Trait Anxiety Inventory (STAI). Consists of six short statements (e.g. &quot;I feel calm&quot;, &quot;I am tense&quot;). For each statement, subject selects a response on a 4-point Likert scale, ranging from 1=Not at all, to 4=Very much.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perception of pain and anxiety: Qualitative questions</measure>
    <time_frame>1 hour</time_frame>
    <description>Qualitative questions (3): 1. How would you describe this art therapy session? 2. What were some sensations you experienced in your body while you were engaged in the session? 3. Is there anything else you would like to say about what you are experiencing in your body and the art therapy session?</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Art Therapy Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardized mixed media art therapy directives (e.g. drawing/painting/collaging within a circle)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Art Therapy Intervention</intervention_name>
    <description>Standardized mixed media art directives.</description>
    <arm_group_label>Art Therapy Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12 to 18 years of age, inclusive&#xD;
&#xD;
          -  Painful condition with self-reported pain score of &gt;3/10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Critical illness as per attending physician&#xD;
&#xD;
          -  Any neurological or developmental condition that precludes engagement in art therapy&#xD;
             or ability to use a self-reported measure of pain&#xD;
&#xD;
          -  Chronic disease associated with pain (e.g. sickle cell disease, fibromyalgia)&#xD;
&#xD;
          -  Medical condition necessitating multiple painful procedures (e.g. malignancy, organ&#xD;
             transplant)&#xD;
&#xD;
          -  Does not speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel S Tsze, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susanne M Bifano, MPS, MSED</last_name>
    <role>Study Director</role>
    <affiliation>NewYork-Presbyterian Morgan Stanley Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NewYork Presbyterian Morgan Stanley Children's Hospital Emergency Department</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x. Erratum In: Br J Clin Psychol. 2020 Jun;59(2):276.</citation>
    <PMID>1393159</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>December 3, 2021</last_update_submitted>
  <last_update_submitted_qc>December 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Daniel S Tsze, MD, MPH</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics in Emergency Medicine at CUMC</investigator_title>
  </responsible_party>
  <keyword>Art Therapy</keyword>
  <keyword>Pain Management</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Emergency Medicine</keyword>
  <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/NCT03755687
org study id: AAAS3531
nct id: NCT03755687
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project is studying adolescents between the ages of 12 to 18 years that come to the
      emergency department and are in pain. We want to find out how well art therapy is able to
      decrease the pain they are experiencing. Art therapy will involve making art and working with
      an art therapist to find new ways of expressing thoughts and feelings through art making.

      In adolescents presenting to the emergency department with a painful condition, our aims are
      as follows:

      Aim #1: To determine the degree that art therapy intervention reduces pain and anxiety.

      Aim #2: To determine the degree that art therapy reduces pain and anxiety 1 hour after the
      intervention.

      Aim #3: To explore the qualitative experience of patients undergoing art therapy
      intervention.
Pain is one of the most common reasons for patients to visit the emergency department (ED),
      and can be treated using both complementary and pharmacological strategies. However, children
      are often undertreated for pain which results in not only short term problems, but long term
      consequences such as trauma and stress-induced disorders; health care avoidance as adults;
      increased pain sensitivity; and decreased response to future analgesia. There have been
      variable efforts made to improve the ED management of pain in children, but adolescents are
      frequently overlooked. A review of the literature revealed that art therapy for pain
      management in adolescents is understudied. The majority of studies describe the effects of
      art therapy on the emotional well-being in surgical and oncology populations in adults and
      children. The studies that did evaluate the effectiveness of art therapy for pain management
      in children focused primarily on surgical and medical oncology populations with children aged
      2-14 years. Of these studies, none evaluated adolescents in the ED, which is a high volume
      and high stress environment that confers a distinct experience for patients compared to other
      medical settings. Evaluation of art therapy interventions using quantitative self-report
      measures with strong validity in children and further delineation of the patient experience
      related to art therapy is necessary. Advanced evaluation of aforementioned interventions
      would expand the evidence base needed to describe effectiveness of these interventions and
      support greater implementation and dissemination. These are the gaps in knowledge that the
      investigators aim to fill with the proposed study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective observational pilot study
primary purpose: Treatment
masking: None (Open Label)
measure: Change in patient pain intensity: Verbal Numerical Rating Scale
time frame: 1 hour
description: Pain intensity measured using the Verbal Numerical Rating Scale. Minimum score (no pain) = 0, maximum score (most/worst pain) = 10.
measure: Change in patient anxiety: Short Form STAI
time frame: 1 hour
description: Anxiety measured using the short form State-Trait Anxiety Inventory (STAI). Consists of six short statements (e.g. "I feel calm", "I am tense"). For each statement, subject selects a response on a 4-point Likert scale, ranging from 1=Not at all, to 4=Very much.
measure: Perception of pain and anxiety: Qualitative questions
time frame: 1 hour
description: Qualitative questions (3): 1. How would you describe this art therapy session? 2. What were some sensations you experienced in your body while you were engaged in the session? 3. Is there anything else you would like to say about what you are experiencing in your body and the art therapy session?
arm group label: Art Therapy Intervention
arm group type: Experimental
description: Standardized mixed media art therapy directives (e.g. drawing/painting/collaging within a circle)
intervention type: Other
intervention name: Art Therapy Intervention
description: Standardized mixed media art directives.
arm group label: Art Therapy Intervention
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel S Tsze, MD, MPH
role: Principal Investigator
affiliation: Columbia University
last name: Susanne M Bifano, MPS, MSED
role: Study Director
affiliation: NewYork-Presbyterian Morgan Stanley Children's Hospital
facility: 
country: United States
citation: Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x. Erratum In: Br J Clin Psychol. 2020 Jun;59(2):276.
PMID: 1393159
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Daniel S Tsze, MD, MPH
investigator title: Associate Professor of Pediatrics in Emergency Medicine at CUMC
sharing ipd: No