<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/NCT03308240</url>
  </required_header>
  <id_info>
    <org_study_id>1037793-2</org_study_id>
    <nct_id>NCT03308240</nct_id>
  </id_info>
  <brief_title>Magic Therapy to Relieve Pediatric Patient Anxiety and Improve the Hospitalization Experience</brief_title>
  <official_title>Magic Therapy to Relieve Pediatric Patient Anxiety and Improve the Hospitalization Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stony Brook 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 study will assess the efficacy of magic therapy services in relieving pediatric patient&#xD;
      anxiety and parent anxiety in an inpatient setting. It will also measure family satisfaction&#xD;
      with child life services during the hospital visit and health professional opinions regarding&#xD;
      such a therapy in an inpatient setting. The primary evaluation method will be through&#xD;
      surveys. No prior investigations have studied using magic therapy as a primary tool to&#xD;
      improve the psychological well-being of pediatric patients over the span of an inpatient&#xD;
      hospitalization. Study and improvement of magic therapy services provides an evidence-based&#xD;
      approach to improve pediatric patient psychological well-being, assist physicians in&#xD;
      obtaining pediatric patient cooperation with procedures, and improving the hospitalization&#xD;
      experience for the family of hospitalized pediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of magic in healthcare has been described across a variety of settings. Several&#xD;
      peer-reviewed publications have described the use of magic to help encourage the recovery of&#xD;
      motor skills 2. Green et al. reported that after the completion of an intense 2-week&#xD;
      magic-theme summer camp, patients with spastic hemiplegia significantly increased the usage&#xD;
      of their affected hand 3. Another investigation sought to study if magic could be used to aid&#xD;
      in communication with mentally-disabled children 4. This study concluded that magic was&#xD;
      effective in building trust, improving the subjects' self-esteem, and enriching their&#xD;
      interpersonal skills.&#xD;
&#xD;
      Magic has also been partially studied in a surgical context for relieving perioperative&#xD;
      anxiety. One study sought to evaluate the efficacy of clowns (whose performance included&#xD;
      magic tricks) in relieving perioperative anxiety 5. Patients that were undergoing surgical&#xD;
      procedures were placed in either a clown group or non-clown group. These patients were not&#xD;
      grouped based on surgical procedures, and patients were included that were undergoing one of&#xD;
      ten different surgeries. Anxiety levels of the pediatric patients were measured in the&#xD;
      waiting room and induction room immediately prior to anesthesia administration. Additionally,&#xD;
      parent state and trait anxiety was measured during their child's induction using the&#xD;
      State-Trait Anxiety Inventory (STAI). Health professionals involved in the surgeries were&#xD;
      also questioned using a questionnaire developed by the authors to obtain health providers'&#xD;
      opinion regarding the presence of clowns as administered in the study. Moreover, clowns&#xD;
      filled out a self-evaluation form regarding how they believed their interaction with the&#xD;
      child went prior to the surgery. The authors found that the clown group displayed decreased&#xD;
      anxiety during anesthesia induction but not in the waiting room. They also documented that&#xD;
      health professionals believed the clowns benefitted the child, but at the same time, a&#xD;
      majority of the staff discouraged continuance of the program due to interference with&#xD;
      operating room procedures.&#xD;
&#xD;
      This study will assess the efficacy of magic therapy services in relieving pediatric patient&#xD;
      anxiety and parent anxiety in an inpatient setting. It will also measure family satisfaction&#xD;
      with child life services during the hospital visit and health professional opinions regarding&#xD;
      such a therapy in an inpatient setting. The primary evaluation method will be through&#xD;
      surveys. No prior investigations have studied using magic therapy as a primary tool to&#xD;
      improve the psychological well-being of pediatric patients over the span of an inpatient&#xD;
      hospitalization. Study and improvement of magic therapy services provides an evidence-based&#xD;
      approach to improve pediatric patient psychological well-being, assist physicians in&#xD;
      obtaining pediatric patient cooperation with procedures, and improving the hospitalization&#xD;
      experience for the family of hospitalized pediatric patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Anticipated">July 26, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 26, 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>
    <intervention_model_description>Two groups will be studied: an experimental group (patient and caregiver) receiving one magic therapy session within the hospitalization period and a control group (patient and caregiver) who will receive standard child life therapies.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the therapeutic benefits of magic therapeutic intervention and impact on patient anxiety age 5-13 years.</measure>
    <time_frame>1-2 days per patient during course of hospitalization</time_frame>
    <description>The Venham Picture Test (VPT) will be administed pre- and post-therapies (magic and standard child life therapies) to patients aged 5-13 to measure anxiety levels. The VPT is a measure of childhood state anxiety that has been validated for use in children aged 3-13 (Venham, Bengston, &amp; Cipes, 1979). It has a series of pictures of faces expressing escalating levels of paint/anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the therapeutic benefits of magic therapeutic intervention and impact on pediatric patient anxiety age 5-16 years.</measure>
    <time_frame>1-2 days per patient during course of hospitalization</time_frame>
    <description>The Facial Image Scale will be administered pre- and post-therapies (magic and standard child life services) to children abed 5-16. The Facial Image Scale is a validated too that utilizes a series of five faces depicting faces ranging in expression from very happy to very unhappy (Buchanan &amp; Niven, 2002). Children are asked at a specific time, which face they feel like at the moment. This scale has been used and validated in children aged 3-18.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the therapeutic benefits of magic therapeutic intervention and impact on patient (age 5-16) and caregiver anxiety.</measure>
    <time_frame>1-2 days per patient during course of hospitalization</time_frame>
    <description>The 6-item State-Trait Anxiety Inventory (STAI) is a validated tool which will be used to measure anxiety pre- and post-therapies (magic and standard child life therapies) for pediatric patients 5-16 years of age, and for caregivers of patients (Marteau &amp; Bekker, 1992; Thanh Nhan Nguyen, Nilsson, Hellström, &amp; Bengtson, 2010). This scale has also been validated in children from age 5-16 (Apell, Paradi, Kokinsky, Nilsson, &amp; Kokinsky, 2011).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine medical professional opinions regarding magic therapeutic services as offered at Stony Brook Children's Hospital.</measure>
    <time_frame>One year, duration of patient/caregiver couplet enrollment</time_frame>
    <description>Medical professionals will receive a questionnaire adapted from a prior study to assess their opinions regarding magic as a therapeutic intervention in an inpatient setting.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Magic Therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medical student magicians who have completed MagicAid training will provide the therapy.&#xD;
Three or four tricks will be performed per patient at the discretion of the magician to cater to patient age and cognition capabilities. Patients in the experimental group may be given the opportunity to learn a magic trick that has been presented to them as well.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Child Life Therapy Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Stony Brook Child Life Specialists will provide standard therapies available to all patients, such as pet therapy, art therapy, music therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Magic Therapy</intervention_name>
    <description>As described in the arm description</description>
    <arm_group_label>Magic Therapy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All 5-18 year-old patients that are admitted to the general pediatric inpatient&#xD;
             pediatric unit at Stony Brook Children's&#xD;
&#xD;
          -  All Caregivers of patients admitted to the general pediatric inpatient pediatric unit&#xD;
             at Stony Brook Children's&#xD;
&#xD;
          -  All medical professionals present on the pediatric inpatient unit at Stony Brook&#xD;
             Children's during magic and child life service therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients/caregivers who are not able to speak/read English&#xD;
&#xD;
          -  Patients under the age of 5 years, as the instruments to be used to measure anxiety&#xD;
             have not been validated in this age group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-8111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maribeth B Chitkara, MD</last_name>
      <phone>631-444-2648</phone>
      <email>maribeth.chitkara@stonybrookmedicine.edu</email>
    </contact>
    <investigator>
      <last_name>Harrison Pravder, BS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Elkin, BS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amanda Leng-Smith, BS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stony Brook University</investigator_affiliation>
    <investigator_full_name>Maribeth Chitkara</investigator_full_name>
    <investigator_title>Associate Professor of Clinical Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Magic</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Pediatric</keyword>
  <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/NCT03308240
org study id: 1037793-2
nct id: NCT03308240
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will assess the efficacy of magic therapy services in relieving pediatric patient
      anxiety and parent anxiety in an inpatient setting. It will also measure family satisfaction
      with child life services during the hospital visit and health professional opinions regarding
      such a therapy in an inpatient setting. The primary evaluation method will be through
      surveys. No prior investigations have studied using magic therapy as a primary tool to
      improve the psychological well-being of pediatric patients over the span of an inpatient
      hospitalization. Study and improvement of magic therapy services provides an evidence-based
      approach to improve pediatric patient psychological well-being, assist physicians in
      obtaining pediatric patient cooperation with procedures, and improving the hospitalization
      experience for the family of hospitalized pediatric patients.
The use of magic in healthcare has been described across a variety of settings. Several
      peer-reviewed publications have described the use of magic to help encourage the recovery of
      motor skills 2. Green et al. reported that after the completion of an intense 2-week
      magic-theme summer camp, patients with spastic hemiplegia significantly increased the usage
      of their affected hand 3. Another investigation sought to study if magic could be used to aid
      in communication with mentally-disabled children 4. This study concluded that magic was
      effective in building trust, improving the subjects' self-esteem, and enriching their
      interpersonal skills.

      Magic has also been partially studied in a surgical context for relieving perioperative
      anxiety. One study sought to evaluate the efficacy of clowns (whose performance included
      magic tricks) in relieving perioperative anxiety 5. Patients that were undergoing surgical
      procedures were placed in either a clown group or non-clown group. These patients were not
      grouped based on surgical procedures, and patients were included that were undergoing one of
      ten different surgeries. Anxiety levels of the pediatric patients were measured in the
      waiting room and induction room immediately prior to anesthesia administration. Additionally,
      parent state and trait anxiety was measured during their child's induction using the
      State-Trait Anxiety Inventory (STAI). Health professionals involved in the surgeries were
      also questioned using a questionnaire developed by the authors to obtain health providers'
      opinion regarding the presence of clowns as administered in the study. Moreover, clowns
      filled out a self-evaluation form regarding how they believed their interaction with the
      child went prior to the surgery. The authors found that the clown group displayed decreased
      anxiety during anesthesia induction but not in the waiting room. They also documented that
      health professionals believed the clowns benefitted the child, but at the same time, a
      majority of the staff discouraged continuance of the program due to interference with
      operating room procedures.

      This study will assess the efficacy of magic therapy services in relieving pediatric patient
      anxiety and parent anxiety in an inpatient setting. It will also measure family satisfaction
      with child life services during the hospital visit and health professional opinions regarding
      such a therapy in an inpatient setting. The primary evaluation method will be through
      surveys. No prior investigations have studied using magic therapy as a primary tool to
      improve the psychological well-being of pediatric patients over the span of an inpatient
      hospitalization. Study and improvement of magic therapy services provides an evidence-based
      approach to improve pediatric patient psychological well-being, assist physicians in
      obtaining pediatric patient cooperation with procedures, and improving the hospitalization
      experience for the family of hospitalized pediatric patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups will be studied: an experimental group (patient and caregiver) receiving one magic therapy session within the hospitalization period and a control group (patient and caregiver) who will receive standard child life therapies.
primary purpose: Treatment
masking: None (Open Label)
measure: To assess the therapeutic benefits of magic therapeutic intervention and impact on patient anxiety age 5-13 years.
time frame: 1-2 days per patient during course of hospitalization
description: The Venham Picture Test (VPT) will be administed pre- and post-therapies (magic and standard child life therapies) to patients aged 5-13 to measure anxiety levels. The VPT is a measure of childhood state anxiety that has been validated for use in children aged 3-13 (Venham, Bengston, & Cipes, 1979). It has a series of pictures of faces expressing escalating levels of paint/anxiety.
measure: To assess the therapeutic benefits of magic therapeutic intervention and impact on pediatric patient anxiety age 5-16 years.
time frame: 1-2 days per patient during course of hospitalization
description: The Facial Image Scale will be administered pre- and post-therapies (magic and standard child life services) to children abed 5-16. The Facial Image Scale is a validated too that utilizes a series of five faces depicting faces ranging in expression from very happy to very unhappy (Buchanan & Niven, 2002). Children are asked at a specific time, which face they feel like at the moment. This scale has been used and validated in children aged 3-18.
measure: To assess the therapeutic benefits of magic therapeutic intervention and impact on patient (age 5-16) and caregiver anxiety.
time frame: 1-2 days per patient during course of hospitalization
description: The 6-item State-Trait Anxiety Inventory (STAI) is a validated tool which will be used to measure anxiety pre- and post-therapies (magic and standard child life therapies) for pediatric patients 5-16 years of age, and for caregivers of patients (Marteau & Bekker, 1992; Thanh Nhan Nguyen, Nilsson, Hellström, & Bengtson, 2010). This scale has also been validated in children from age 5-16 (Apell, Paradi, Kokinsky, Nilsson, & Kokinsky, 2011).
measure: To determine medical professional opinions regarding magic therapeutic services as offered at Stony Brook Children's Hospital.
time frame: One year, duration of patient/caregiver couplet enrollment
description: Medical professionals will receive a questionnaire adapted from a prior study to assess their opinions regarding magic as a therapeutic intervention in an inpatient setting.
arm group label: Magic Therapy Group
arm group type: Experimental
description: Medical student magicians who have completed MagicAid training will provide the therapy.
Three or four tricks will be performed per patient at the discretion of the magician to cater to patient age and cognition capabilities. Patients in the experimental group may be given the opportunity to learn a magic trick that has been presented to them as well.
arm group label: Standard Child Life Therapy Group
arm group type: No Intervention
description: Stony Brook Child Life Specialists will provide standard therapies available to all patients, such as pet therapy, art therapy, music therapy.
intervention type: Behavioral
intervention name: Magic Therapy
description: As described in the arm description
arm group label: Magic Therapy Group
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stony Brook University
investigator full name: Maribeth Chitkara
investigator title: Associate Professor of Clinical Pediatrics
mesh term: Anxiety Disorders
sharing ipd: No