<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/NCT03828591</url>
  </required_header>
  <id_info>
    <org_study_id>ENDO.PS.</org_study_id>
    <nct_id>NCT03828591</nct_id>
  </id_info>
  <brief_title>Endometriosis and Psychological Support</brief_title>
  <official_title>The Impact of Psychological Support During the Hospitalization in Women With Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endometriosis is a common disease, causing significant pain (dysmenorrhea, dysuria, dyspnea,&#xD;
      dyspareunia, and chronic pelvic pain) and infertility, drastically reducing patients' quality&#xD;
      of life.&#xD;
&#xD;
      Endometriosis surgery is often a stressful event for the patient. For that reason,&#xD;
      psychological support can improve patients' general health state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of endometriosis,&#xD;
      undergoing surgery for the removal of endometriotic lesions are included in the study.&#xD;
&#xD;
      Psychological support is offered to all women one month before and one month after surgery. A&#xD;
      group of patients will receive intensive psychological support during hospitalization.&#xD;
&#xD;
      Patients are divided into 2 groups:&#xD;
&#xD;
      Group A: patients receiving intensive psychological support during hospitalization&#xD;
&#xD;
      Group B: patients not receiving intensive psychological support during hospitalization&#xD;
&#xD;
      After surgery, patients will be included in the post-operative follow-up, as usual in the&#xD;
      investigator's clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>General health state</measure>
    <time_frame>From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery</time_frame>
    <description>Measurement of quality of life of patients underwent surgery for endometriosis, using the validated questionnaire Clinical Outcomes In Routine Evaluation, with a total score from 1 (the best outcome) to more than 85 (the worse outcome), where: 1 to 20 is Healthy; 21 to 33 is Low level; 34 to 50 is Mild level; 51 to 67 is Moderate level; 68 to 84 is Moderate to severe level; more than 85 is Severe level. The questionnaire is submitted one month before surgery and at the hospitalization discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain: Numeric Rating Scale</measure>
    <time_frame>Postoperative: at the hospitalization discharge (assessed up to 7 days after surgery) and one month after surgery</time_frame>
    <description>Evaluation of postoperative pain using Numeric Rating Scale, from 0 to 10 (where 0 is no pain and 10 is the worse pain ever).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery</time_frame>
    <description>Measurement of anxiety and depression of patients underwent surgery for endometriosis, using the validated questionnaire Hospital Anxiety and Depression Scale, from 0 (the best outcome) to 21 (the worse outcome), where: 0 to 7 is Normal; 8 to 10 is Borderline case; 11 to 21 is Abnormal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery</time_frame>
    <description>Measurement of stress in patients underwent surgery for endometriosis, using the validated questionnaire Perceived Stress Scale, from 0 (the best outcome) to 40 (the worse outcome), where scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Group A (intensive support)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients that receive standard and intensive psychological support during hospitalization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (standard support)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients that receive only standard psychological support during hospitalization</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intensive psychological support</intervention_name>
    <description>Two meeting with a psychologist during the hospitalization (the first two days after surgery; the second one at the moment of the hospitalization discharge)</description>
    <arm_group_label>Group A (intensive support)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard psychological support</intervention_name>
    <description>Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery</description>
    <arm_group_label>Group A (intensive support)</arm_group_label>
    <arm_group_label>Group B (standard support)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing surgery for endometriosis&#xD;
&#xD;
          -  Patients that have signed an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with active or history of psychological/psychiatric diseases&#xD;
&#xD;
          -  Patients that refuse psychological support&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alessandro Arena, MD</last_name>
    <phone>0512144385</phone>
    <email>alessandroarena1588@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessandro Arena, MD</last_name>
      <phone>0512144385</phone>
      <email>alessandroarena1588@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Renato Seracchioli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alessandro Arena, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Federica Manzara, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chiara Ferracuti, Psychologist</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Manuela Mastronardi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>Renato Seracchioli</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Endometriosis</keyword>
  <keyword>Psychological support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</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/NCT03828591
org study id: ENDO.PS.
nct id: NCT03828591
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Endometriosis is a common disease, causing significant pain (dysmenorrhea, dysuria, dyspnea,
      dyspareunia, and chronic pelvic pain) and infertility, drastically reducing patients' quality
      of life.

      Endometriosis surgery is often a stressful event for the patient. For that reason,
      psychological support can improve patients' general health state.
Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of endometriosis,
      undergoing surgery for the removal of endometriotic lesions are included in the study.

      Psychological support is offered to all women one month before and one month after surgery. A
      group of patients will receive intensive psychological support during hospitalization.

      Patients are divided into 2 groups:

      Group A: patients receiving intensive psychological support during hospitalization

      Group B: patients not receiving intensive psychological support during hospitalization

      After surgery, patients will be included in the post-operative follow-up, as usual in the
      investigator's clinical practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: General health state
time frame: From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
description: Measurement of quality of life of patients underwent surgery for endometriosis, using the validated questionnaire Clinical Outcomes In Routine Evaluation, with a total score from 1 (the best outcome) to more than 85 (the worse outcome), where: 1 to 20 is Healthy; 21 to 33 is Low level; 34 to 50 is Mild level; 51 to 67 is Moderate level; 68 to 84 is Moderate to severe level; more than 85 is Severe level. The questionnaire is submitted one month before surgery and at the hospitalization discharge.
measure: Postoperative pain: Numeric Rating Scale
time frame: Postoperative: at the hospitalization discharge (assessed up to 7 days after surgery) and one month after surgery
description: Evaluation of postoperative pain using Numeric Rating Scale, from 0 to 10 (where 0 is no pain and 10 is the worse pain ever).
measure: Anxiety and Depression
time frame: From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
description: Measurement of anxiety and depression of patients underwent surgery for endometriosis, using the validated questionnaire Hospital Anxiety and Depression Scale, from 0 (the best outcome) to 21 (the worse outcome), where: 0 to 7 is Normal; 8 to 10 is Borderline case; 11 to 21 is Abnormal.
measure: Stress
time frame: From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
description: Measurement of stress in patients underwent surgery for endometriosis, using the validated questionnaire Perceived Stress Scale, from 0 (the best outcome) to 40 (the worse outcome), where scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress.
arm group label: Group A (intensive support)
arm group type: Other
description: Patients that receive standard and intensive psychological support during hospitalization
arm group label: Group B (standard support)
arm group type: Other
description: Patients that receive only standard psychological support during hospitalization
intervention type: Procedure
intervention name: Intensive psychological support
description: Two meeting with a psychologist during the hospitalization (the first two days after surgery; the second one at the moment of the hospitalization discharge)
arm group label: Group A (intensive support)
intervention type: Procedure
intervention name: Standard psychological support
description: Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery
arm group label: Group A (intensive support)
arm group label: Group B (standard support)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Alessandro Arena, MD
phone: 0512144385
email: alessandroarena1588@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: Renato Seracchioli
investigator title: principal investigator
mesh term: Endometriosis