<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/NCT04413773</url>
  </required_header>
  <id_info>
    <org_study_id>VideoAnx2020</org_study_id>
    <nct_id>NCT04413773</nct_id>
  </id_info>
  <brief_title>Patient Anxiety Reduction in Children by Using Simple Explanation Videos</brief_title>
  <official_title>Use of Simple Explanation Videos to Reduce Perioperative Patient Anxiety in Children.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</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 reduction of preoperative anxiety in children and adolescents before an elective surgical&#xD;
      procedure is an important clinical question in perioperative care. Adequate, age-appropriate&#xD;
      patient information about the processes of the inpatient stay plays an important role in&#xD;
      order to address possible worries and fears to reduce.&#xD;
&#xD;
      The medium video is popular with children and adolescents today and offers the possibility of&#xD;
      an easily understandable and vivid presentation of information.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies by the health insurance companies, scientific publications and economic papers show&#xD;
      that in times of increasing economic interests of the hospitals and the resulting necessity&#xD;
      of economic working methods in the medical system, less time remains for human interaction.&#xD;
      This creates areas of conflict, such as the patient's right to information regarding the time&#xD;
      available to medical personnel. This in turn leads to significant stress factors in patients&#xD;
      who are involved in the treatment and mostly on the communication level, such as &quot;Missing&#xD;
      information&quot;, &quot;misunderstood visit&quot;, &quot;missing partnership relationship&quot; refer to what is&#xD;
      reflected in patient satisfaction and fears. Studies show how important good perioperative&#xD;
      psychosocial care is for reducing these circumstances in children, also and especially in the&#xD;
      context of further development. The drug options for calming and reducing anxiety are already&#xD;
      known, but there are also increasing numbers of non-drug approaches to reducing anxiety and&#xD;
      stress in the literature. Painting therapy and clinic clowns are examples. However, access to&#xD;
      such resources is limited and costs are permanently high. New technologies, e.g. mobile&#xD;
      phones and tablets, with the associated media, increasingly finding their way into our&#xD;
      society, are now inexpensive to buy and have become an integral part of most households. Such&#xD;
      devices and media are increasingly used in clinical studies and patient care. Their use is&#xD;
      tested extensively in modern medicine, e.g. to avoid unnecessary postoperative consultations&#xD;
      in the emergency room or to increase cognitive learning for children. Even small children can&#xD;
      use and understand these media early on. Videos are one of the most common media already&#xD;
      understood by the smallest patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</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>randomized controlled trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in perioperative Anxiety in Children (T1 vs. T2, TAU vs. Video)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The primary endpoint was to analyze the preoperative state-anxiety in children before (t1) and after (t2) the intervention (video), compared with standard care (TAU). we use State-Trait-Anxiety-Operation-Inventory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in perioperative Anxiety in Parental Report (T1 vs. T2, TAU vs. Video)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Secondary endpoint was to analyze the preoperative trait-anxiety in children, as well as the preoperative state- and trait-anxiety in the parental report. We use the State-Trait-Anxiety-Operation-Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nurse reported anxiety before and after Intervention (T1 vs. T2)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>we analyzed the nurse-reported anxiety status of the child before (t1) and after (t2) the intervention, we use a short State-Anxiety-Inventory (Krohne et al. 2005)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative Anxiety separated in state and trait anxiety (T1 vs T2, TAU vs Video)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>difference between anxiety levels, again separated in state and trait, reported by children, We use the State-Trait-Anxiety-Operation-Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of STOA in a pediatric cohort</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Evaluation of Questionnaire in a pediatric cohort</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Perioperative Anxiety</condition>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as Usual, Explanation of standard procedures before, during and after surgery by nurse</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual + Video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment as usual and additionally Video</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual + Video</intervention_name>
    <description>Additionally to treatment as usual a video is shown to participant about procedures on the ward before, during and after surgery</description>
    <arm_group_label>Treatment as usual + Video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>Explanation of standard procedures before, during and after surgery by nurse</description>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients (children) who present themselves planned in the Altona Children's&#xD;
             Hospital or in the University Clinic Hamburg Eppendorf in the course of an upcoming&#xD;
             elective operation.&#xD;
&#xD;
          2. The surgical intervention must take place in one of the following body regions:&#xD;
             thorax, abdomen and / or extremities (incl. Head and neck)&#xD;
&#xD;
          3. A signed declaration of consent from the parents or legal guardians is available&#xD;
&#xD;
          4. The patient has given a declaration of consent&#xD;
&#xD;
          5. No mental illnesses may be diagnosed&#xD;
&#xD;
          6. No chronic pre-existing conditions may be diagnosed&#xD;
&#xD;
          7. Age of the patients is between 6 and 17 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No signed declaration of consent from the parents or legal guardians available&#xD;
&#xD;
          2. There is no signed declaration of consent from the patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julian Trah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of pediatric surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Hamburg Eppendorf - Department of pediatric surgery</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Altona Children's Hospital</name>
      <address>
        <city>Hamburg</city>
        <zip>22763</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>December 6, 2021</last_update_submitted>
  <last_update_submitted_qc>December 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsklinikum Hamburg-Eppendorf</investigator_affiliation>
    <investigator_full_name>Dr. med. Julian Trah</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Anxiety, Video education, perioperative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT04413773
org study id: VideoAnx2020
nct id: NCT04413773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The reduction of preoperative anxiety in children and adolescents before an elective surgical
      procedure is an important clinical question in perioperative care. Adequate, age-appropriate
      patient information about the processes of the inpatient stay plays an important role in
      order to address possible worries and fears to reduce.

      The medium video is popular with children and adolescents today and offers the possibility of
      an easily understandable and vivid presentation of information.
Studies by the health insurance companies, scientific publications and economic papers show
      that in times of increasing economic interests of the hospitals and the resulting necessity
      of economic working methods in the medical system, less time remains for human interaction.
      This creates areas of conflict, such as the patient's right to information regarding the time
      available to medical personnel. This in turn leads to significant stress factors in patients
      who are involved in the treatment and mostly on the communication level, such as "Missing
      information", "misunderstood visit", "missing partnership relationship" refer to what is
      reflected in patient satisfaction and fears. Studies show how important good perioperative
      psychosocial care is for reducing these circumstances in children, also and especially in the
      context of further development. The drug options for calming and reducing anxiety are already
      known, but there are also increasing numbers of non-drug approaches to reducing anxiety and
      stress in the literature. Painting therapy and clinic clowns are examples. However, access to
      such resources is limited and costs are permanently high. New technologies, e.g. mobile
      phones and tablets, with the associated media, increasingly finding their way into our
      society, are now inexpensive to buy and have become an integral part of most households. Such
      devices and media are increasingly used in clinical studies and patient care. Their use is
      tested extensively in modern medicine, e.g. to avoid unnecessary postoperative consultations
      in the emergency room or to increase cognitive learning for children. Even small children can
      use and understand these media early on. Videos are one of the most common media already
      understood by the smallest patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled trial
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in perioperative Anxiety in Children (T1 vs. T2, TAU vs. Video)
time frame: Through study completion, an average of 1 year
description: The primary endpoint was to analyze the preoperative state-anxiety in children before (t1) and after (t2) the intervention (video), compared with standard care (TAU). we use State-Trait-Anxiety-Operation-Inventory
measure: Change in perioperative Anxiety in Parental Report (T1 vs. T2, TAU vs. Video)
time frame: Through study completion, an average of 1 year
description: Secondary endpoint was to analyze the preoperative trait-anxiety in children, as well as the preoperative state- and trait-anxiety in the parental report. We use the State-Trait-Anxiety-Operation-Inventory
measure: Nurse reported anxiety before and after Intervention (T1 vs. T2)
time frame: Through study completion, an average of 1 year
description: we analyzed the nurse-reported anxiety status of the child before (t1) and after (t2) the intervention, we use a short State-Anxiety-Inventory (Krohne et al. 2005)
measure: Perioperative Anxiety separated in state and trait anxiety (T1 vs T2, TAU vs Video)
time frame: Through study completion, an average of 1 year
description: difference between anxiety levels, again separated in state and trait, reported by children, We use the State-Trait-Anxiety-Operation-Inventory
measure: Evaluation of STOA in a pediatric cohort
time frame: Through study completion, an average of 1 year
description: Evaluation of Questionnaire in a pediatric cohort
arm group label: Treatment as usual
arm group type: Active Comparator
description: Treatment as Usual, Explanation of standard procedures before, during and after surgery by nurse
arm group label: Treatment as usual + Video
arm group type: Experimental
description: Treatment as usual and additionally Video
intervention type: Other
intervention name: Treatment as usual + Video
description: Additionally to treatment as usual a video is shown to participant about procedures on the ward before, during and after surgery
arm group label: Treatment as usual + Video
intervention type: Other
intervention name: Treatment as usual
description: Explanation of standard procedures before, during and after surgery by nurse
arm group label: Treatment as usual
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Julian Trah, MD
role: Principal Investigator
affiliation: Department of pediatric surgery
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Universitätsklinikum Hamburg-Eppendorf
investigator full name: Dr. med. Julian Trah
investigator title: Medical Doctor
mesh term: Anxiety Disorders