xml: <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/NCT06007313</url>
    </required_header>
    <id_info>
      <org_study_id>swyclinical2023</org_study_id>
      <nct_id>NCT06007313</nct_id>
    </id_info>
    <brief_title>Mental Stress and Bowel Preparation Quality</brief_title>
    <official_title>A Cross-sectional Study of the Relationship Between Mental Stress and Bowel Preparation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</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>
        The goal of this cross-sectional study was to explore the relationship between physical and&#xD;
        psychological stress and the quality of bowel preparation before a colonoscopy examination,&#xD;
        in order to improve the quality of bowel preparation.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
        Does physical and psychological stress affect the quality of colonoscopic bowel preparation,&#xD;
        and delay disease detection? How can we improve the quality of colonoscopy？ Participants will&#xD;
        be asked to complete a questionnaire containing their demographics, history of diseases and&#xD;
        drugs, lifestyle habits, and physical and 14-item perceived stress scale(PSS-14). Quality of&#xD;
        bowel preparation was assessed by the Boston bowel preparation scale（BPS）.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 1000 patients who were to undergo colonoscopy at the Endoscopy Centre of the&#xD;
        Department of Gastroenterology, Renji Hospital, from May 2023 to August 2023 were collected,&#xD;
        and the general information and the physical and mental stress test scale of the patients&#xD;
        were collected by questionnaires from random samples, and they were screened for enrolment&#xD;
        according to the inclusion and exclusion criteria. The correlation between physical and&#xD;
        mental stress and the quality of bowel preparation for colonoscopy was analyzed according to&#xD;
        the Boston Rating Scale (BPS), which is used by colonoscopists to assess the quality of bowel&#xD;
        preparation for each patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The quality of bowel preparation</measure>
      <time_frame>During colonoscopy, about 20 minutes</time_frame>
      <description>Quality of bowel preparation was assessed by the Boston bowel preparation scale(BPS). The BPS is used to assess the quality of bowel preparation on a 9-point scale. The colon is divided into three sections (right-sided colon, transverse colon and left-sided colon) and each segment is scored on a four-point scale (0-3), with higher scores indicating a cleaner bowel. The total Boston score is 9, with a score of less than 6 indicating poor bowel preparation.</description>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Colonoscopy</condition>
    <condition>Intestinal Disease</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who underwent colonoscopy from May 2023-August 2023 at the Endoscopy Centre, Renji&#xD;
          East Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants aged 18 to 75 years old with an indication for colonoscopy&#xD;
  &#xD;
            -  Participants signed an informed consent form for colonoscopy and underwent colonoscopy&#xD;
  &#xD;
            -  Participants not be with a history of digestive tumors, active inflammatory bowel&#xD;
               disease and other conditions that significantly affect colonic motility&#xD;
  &#xD;
            -  Participants with good communication and comprehension skills and be able to answer&#xD;
               assessment questions accurately&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Withdrawal prior to colonoscopy&#xD;
  &#xD;
            -  Incomplete completion of information&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wen-yu Su, Ph.D.</last_name>
      <phone>00-86-021-13761981114</phone>
      <email>swy260589@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Renji Hospital, School of Medicine, Shanghai Jiao Tong University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200127</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wen-yu Su, Ph.D.</last_name>
        <phone>00-86-021-13761981114</phone>
        <email>swy260589@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intestinal Diseases</mesh_term>
      <mesh_term>Stress, Psychological</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007313
  org study id: swyclinical2023
  nct id: NCT06007313
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this cross-sectional study was to explore the relationship between physical and
        psychological stress and the quality of bowel preparation before a colonoscopy examination,
        in order to improve the quality of bowel preparation.
  
        The main questions it aims to answer are:
  
        Does physical and psychological stress affect the quality of colonoscopic bowel preparation,
        and delay disease detection? How can we improve the quality of colonoscopy？ Participants will
        be asked to complete a questionnaire containing their demographics, history of diseases and
        drugs, lifestyle habits, and physical and 14-item perceived stress scale(PSS-14). Quality of
        bowel preparation was assessed by the Boston bowel preparation scale（BPS）.
  A total of 1000 patients who were to undergo colonoscopy at the Endoscopy Centre of the
        Department of Gastroenterology, Renji Hospital, from May 2023 to August 2023 were collected,
        and the general information and the physical and mental stress test scale of the patients
        were collected by questionnaires from random samples, and they were screened for enrolment
        according to the inclusion and exclusion criteria. The correlation between physical and
        mental stress and the quality of bowel preparation for colonoscopy was analyzed according to
        the Boston Rating Scale (BPS), which is used by colonoscopists to assess the quality of bowel
        preparation for each patient.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: The quality of bowel preparation
  time frame: During colonoscopy, about 20 minutes
  description: Quality of bowel preparation was assessed by the Boston bowel preparation scale(BPS). The BPS is used to assess the quality of bowel preparation on a 9-point scale. The colon is divided into three sections (right-sided colon, transverse colon and left-sided colon) and each segment is scored on a four-point scale (0-3), with higher scores indicating a cleaner bowel. The total Boston score is 9, with a score of less than 6 indicating poor bowel preparation.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Wen-yu Su, Ph.D.
  phone: 00-86-021-13761981114
  email: swy260589@126.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Intestinal Diseases
  mesh term: Stress, Psychological