<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/NCT04436354</url>
  </required_header>
  <id_info>
    <org_study_id>GaziosmanpasaTREHa</org_study_id>
    <nct_id>NCT04436354</nct_id>
  </id_info>
  <brief_title>The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy</brief_title>
  <official_title>The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gaziosmanpasa Research and Education Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gaziosmanpasa Research and Education Hospital</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 present study revealed that the TL position is supposed to be more efficient not only for&#xD;
      lowering pain score but also reducing the procedural time. Also, performing hysteroscopy in&#xD;
      this position may be easier for doctors than in the lithotomy position.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      VOH is a widely used diagnostic method and seems to be getting more into outpatient clinics.&#xD;
      Despite its huge contribution to clinical practice, pain during the procedure is an important&#xD;
      limiting factor. We aimed to investigate the effect of the trendelenburg lithotomy position&#xD;
      to the pain and procedural time.However, there is a scarcity of research on this subject.&#xD;
      Therefore, the rationale of the study was to enlighten the gap in the literature regarding&#xD;
      the pain score and procedural time during VOH for diagnostic purposes in TL position. In&#xD;
      order to gain scientific evidence, a randomized controlled trial was conducted to compare&#xD;
      pain score and duration of procedure between the standard lithotomy position and TL position.&#xD;
      Also, the convenience for the physician performing the procedure was assessed. To the best of&#xD;
      our knowledge, this is the first study in the literature investigating the effect of the&#xD;
      position of the patient during the procedure on both time, pain, and the convenience for the&#xD;
      physician simultaneously.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">April 16, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Score for pain</measure>
    <time_frame>12 months</time_frame>
    <description>The Visual Pain Scale (VPS) was used to evaluate pain levels with 0 represented pain-free, while 10 described the most severe pain (Ekin et al. 2009; Price et al. 1983). Patients were asked to mark the pain expressing point on the VPS immediately after VOH. The severity of pain is determined by the value of the point (cm) marked by the participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>procedural times</measure>
    <time_frame>12 months</time_frame>
    <description>minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>attitudinal Likert type survey</measure>
    <time_frame>12 months</time_frame>
    <description>with a 5-point attitudinal Likert type survey; a psychometric scale commonly used to score responses in a questionnaire. The ease or difficulty of the procedure was categorized as 1-very easy, 2-easy, 3-ineffective, 4-difficult, 5-very difficult, and the physician performing the procedure marked&#xD;
the appropriate section for each VOH procedure in the scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">157</enrollment>
  <condition>Uterine Diseases</condition>
  <arm_group>
    <arm_group_label>vaginoscopic office hysteroscopy in the trendelenburg position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>vaginoscopic office hysteroscopy in lithotomy position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>vaginoscopic office hysteroscopy</intervention_name>
    <description>comparison of procedural time and pain scores of patients in different gynecologycal positions</description>
    <arm_group_label>vaginoscopic office hysteroscopy in lithotomy position</arm_group_label>
    <arm_group_label>vaginoscopic office hysteroscopy in the trendelenburg position</arm_group_label>
    <other_name>positions</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  uterine disorders&#xD;
&#xD;
          -  abnormal uterine bleeding&#xD;
&#xD;
          -  infertility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  cervical disorders&#xD;
&#xD;
          -  pelvic infections&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34255</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>September 19, 2021</last_update_submitted>
  <last_update_submitted_qc>September 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gaziosmanpasa Research and Education Hospital</investigator_affiliation>
    <investigator_full_name>Fatma ketenci gencer</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>vaginoscopic office hysteroscopy</keyword>
  <keyword>lithotomy position</keyword>
  <keyword>trendelenburg lithotomy position</keyword>
  <keyword>visual pain score</keyword>
  <keyword>procedural time</keyword>
  <keyword>Likert scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04436354
org study id: GaziosmanpasaTREHa
nct id: NCT04436354
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study revealed that the TL position is supposed to be more efficient not only for
      lowering pain score but also reducing the procedural time. Also, performing hysteroscopy in
      this position may be easier for doctors than in the lithotomy position.
VOH is a widely used diagnostic method and seems to be getting more into outpatient clinics.
      Despite its huge contribution to clinical practice, pain during the procedure is an important
      limiting factor. We aimed to investigate the effect of the trendelenburg lithotomy position
      to the pain and procedural time.However, there is a scarcity of research on this subject.
      Therefore, the rationale of the study was to enlighten the gap in the literature regarding
      the pain score and procedural time during VOH for diagnostic purposes in TL position. In
      order to gain scientific evidence, a randomized controlled trial was conducted to compare
      pain score and duration of procedure between the standard lithotomy position and TL position.
      Also, the convenience for the physician performing the procedure was assessed. To the best of
      our knowledge, this is the first study in the literature investigating the effect of the
      position of the patient during the procedure on both time, pain, and the convenience for the
      physician simultaneously.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Visual Analog Score for pain
time frame: 12 months
description: The Visual Pain Scale (VPS) was used to evaluate pain levels with 0 represented pain-free, while 10 described the most severe pain (Ekin et al. 2009; Price et al. 1983). Patients were asked to mark the pain expressing point on the VPS immediately after VOH. The severity of pain is determined by the value of the point (cm) marked by the participant
measure: procedural times
time frame: 12 months
description: minutes
measure: attitudinal Likert type survey
time frame: 12 months
description: with a 5-point attitudinal Likert type survey; a psychometric scale commonly used to score responses in a questionnaire. The ease or difficulty of the procedure was categorized as 1-very easy, 2-easy, 3-ineffective, 4-difficult, 5-very difficult, and the physician performing the procedure marked
the appropriate section for each VOH procedure in the scale.
arm group label: vaginoscopic office hysteroscopy in the trendelenburg position
arm group type: Experimental
arm group label: vaginoscopic office hysteroscopy in lithotomy position
arm group type: Experimental
intervention type: Procedure
intervention name: vaginoscopic office hysteroscopy
description: comparison of procedural time and pain scores of patients in different gynecologycal positions
arm group label: vaginoscopic office hysteroscopy in lithotomy position
arm group label: vaginoscopic office hysteroscopy in the trendelenburg position
other name: positions
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Gaziosmanpasa Research and Education Hospital
investigator full name: Fatma ketenci gencer
investigator title: Principle investigator
mesh term: Uterine Diseases
sharing ipd: Yes