<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/NCT03274336</url>
  </required_header>
  <id_info>
    <org_study_id>Schulthess_Anä_12</org_study_id>
    <nct_id>NCT03274336</nct_id>
  </id_info>
  <brief_title>Influence of Audiovisual Aids in the Preanesthetic Interview</brief_title>
  <official_title>Influence of Audiovisual Aids in the Preanesthetic Interview: A Comparison of the Effect of Face-to-face-interview Versus a Brochure and Video Assisted Interview</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schulthess Klinik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schulthess Klinik</source>
  <oversight_info>
    <has_dmc>Yes</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>
      1000 patients will be asked to fill out a questionnaire about preanesthetic visit right after&#xD;
      the interview. On a daily randomization the Groups will be assigned to: Group A =&#xD;
      face-to-face interview; Group B = interview plus brochure, Group C= interview plus movie.&#xD;
&#xD;
      Evaluation of patient satisfaction und knowledge transfer will be evaluated with a&#xD;
      questionnaire filled out right after the interview with the anesthesist.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Actual">September 30, 2015</completion_date>
  <primary_completion_date type="Actual">September 1, 2015</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>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction on a questionnaire</measure>
    <time_frame>15 Minutes</time_frame>
    <description>Patient satisfaction after the preanesthetic interview is measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time</measure>
    <time_frame>30 Minutes</time_frame>
    <description>time needed for the preanesthetic interview in Minutes</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1172</enrollment>
  <condition>Patient Satisfaction</condition>
  <arm_group>
    <arm_group_label>interview</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>questionnaire after face-to-face interview</description>
  </arm_group>
  <arm_group>
    <arm_group_label>brochure</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>questionnaire interview plus brochure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>movie</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>questionnaire interview plus movie</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>questionnaire post preanesthetic interview</description>
    <arm_group_label>brochure</arm_group_label>
    <arm_group_label>interview</arm_group_label>
    <arm_group_label>movie</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>face-to-face interview</intervention_name>
    <description>Group A = face-to-face interview</description>
    <arm_group_label>interview</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>brochure</intervention_name>
    <description>after reading a brochure a face to face interview will take place</description>
    <arm_group_label>brochure</arm_group_label>
    <arm_group_label>interview</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>movie</intervention_name>
    <description>after seeing a film about the procedure a face-to-face interview will take place</description>
    <arm_group_label>interview</arm_group_label>
    <arm_group_label>movie</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  voluntary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  language Problems&#xD;
&#xD;
          -  not able to read or write&#xD;
&#xD;
          -  patients does not want to fill out questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Berthold Moser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schulthess Klinik</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>patient satisfaction</keyword>
  <keyword>preanesthesia</keyword>
  <keyword>movie</keyword>
  <keyword>brochure</keyword>
  <keyword>face-to-face interview</keyword>
  <!-- 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/NCT03274336
org study id: Schulthess_Anä_12
nct id: NCT03274336
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
1000 patients will be asked to fill out a questionnaire about preanesthetic visit right after
      the interview. On a daily randomization the Groups will be assigned to: Group A =
      face-to-face interview; Group B = interview plus brochure, Group C= interview plus movie.

      Evaluation of patient satisfaction und knowledge transfer will be evaluated with a
      questionnaire filled out right after the interview with the anesthesist.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Patient satisfaction on a questionnaire
time frame: 15 Minutes
description: Patient satisfaction after the preanesthetic interview is measured
measure: time
time frame: 30 Minutes
description: time needed for the preanesthetic interview in Minutes
arm group label: interview
arm group type: Active Comparator
description: questionnaire after face-to-face interview
arm group label: brochure
arm group type: Placebo Comparator
description: questionnaire interview plus brochure
arm group label: movie
arm group type: Placebo Comparator
description: questionnaire interview plus movie
intervention type: Behavioral
intervention name: questionnaire
description: questionnaire post preanesthetic interview
arm group label: brochure
arm group label: interview
arm group label: movie
intervention type: Behavioral
intervention name: face-to-face interview
description: Group A = face-to-face interview
arm group label: interview
intervention type: Behavioral
intervention name: brochure
description: after reading a brochure a face to face interview will take place
arm group label: brochure
arm group label: interview
intervention type: Behavioral
intervention name: movie
description: after seeing a film about the procedure a face-to-face interview will take place
arm group label: interview
arm group label: movie
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Berthold Moser, MD
role: Principal Investigator
affiliation: Schulthess Klinik
responsible party type: Sponsor