<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/NCT01703871</url>
  </required_header>
  <id_info>
    <org_study_id>HM-1</org_study_id>
    <nct_id>NCT01703871</nct_id>
  </id_info>
  <brief_title>Music During Diagnostic Hysteroscopy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Campus Bio-Medico University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Campus Bio-Medico University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Office Hysteroscopy is associated with a level of anxiety that could condition tolerability&#xD;
      of the procedure by the patient.&#xD;
&#xD;
      The aim of this study is to evaluate the impact of music on anxiety state, expected and&#xD;
      received pain by patients during office hysteroscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pain</condition>
  <condition>Anxiety</condition>
  <condition>Tolerability</condition>
  <eligibility>
    <study_pop>
      <textblock>
        primary care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients candidates for office hysteroscopy in menopausal status or in childbearing&#xD;
             age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous diagnostic hysteroscopy and/or RCU&#xD;
&#xD;
          -  Current or recent pelvic Inflammation&#xD;
&#xD;
          -  Invasive cervix cancer&#xD;
&#xD;
          -  Ongoing pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 8, 2012</last_update_submitted>
  <last_update_submitted_qc>October 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Campus Bio-Medico University</investigator_affiliation>
    <investigator_full_name>Cafa Ester Valentina</investigator_full_name>
    <investigator_title>medical doctor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01703871
org study id: HM-1
nct id: NCT01703871
lead sponsor: 
has dmc: No
Office Hysteroscopy is associated with a level of anxiety that could condition tolerability
      of the procedure by the patient.

      The aim of this study is to evaluate the impact of music on anxiety state, expected and
      received pain by patients during office hysteroscopy.
observational model: Cohort
time perspective: Prospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Campus Bio-Medico University
investigator full name: Cafa Ester Valentina
investigator title: medical doctor