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/NCT05980975</url>
    </required_header>
    <id_info>
      <org_study_id>MersinUniversityy</org_study_id>
      <nct_id>NCT05980975</nct_id>
    </id_info>
    <brief_title>The Effect of Coffee and Hot Water on Gastroıntestınal Functıons</brief_title>
    <official_title>The Effect of Coffee and Hot Water Consumptıon on Gastroıntestınal System Functıons After Cesarrean Sectıon</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mersin University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mersin University</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 aim of this study is to examine the effects of coffee and hot water consumption on&#xD;
        gastrointestinal system functions after cesarean section performed under general anesthesia.&#xD;
        The study is in a randomized controlled experimental design.&#xD;
  &#xD;
        The sample of the study consisted of 25 participants in the coffee group (Group 1), 26&#xD;
        participants in the hot water group (Group 2) and 27 participants in the control group (Group&#xD;
        3). After cesarean section, at the 4th, 8th and 12th hours of the operation, the first&#xD;
        intervention group (coffee group) received 2 gr. granulated coffee, the second intervention&#xD;
        group (hot water group) was given 100 ml of 50-60 C0 sugar-free hot water, the third group&#xD;
        (control group) was given no intervention other than routine applications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: The aim of this study is to examine the effects of coffee and hot water&#xD;
        consumption on gastrointestinal system functions after cesarean section performed under&#xD;
        general anesthesia.&#xD;
  &#xD;
        Materials and Methods: The study is in a randomized controlled experimental design. Patients&#xD;
        who had an uncomplicated cesarean section under general anesthesia, were older than 18 years&#xD;
        of age, completed the 37th week of pregnancy, did not have any gastrointestinal system&#xD;
        disease that could affect the results of the study, and did not use drugs, and who could&#xD;
        understand and speak Turkish were included in the study. The sample of the study consisted of&#xD;
        25 participants in the coffee group (Group 1), 26 participants in the hot water group (Group&#xD;
        2) and 27 participants in the control group (Group 3). After cesarean section, at the 4th,&#xD;
        8th and 12th hours of the operation, the first intervention group (coffee group) received 2&#xD;
        gr. granulated coffee, the second intervention group (hot water group) was given 100 ml of&#xD;
        50-60 C0 sugar-free hot water, the third group (control group) was given no intervention&#xD;
        other than routine applications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">July 15, 2023</completion_date>
    <primary_completion_date type="Actual">February 1, 2022</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>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>First bowel sound time listened with stethoscope</measure>
      <time_frame>24 hours</time_frame>
      <description>After cesarean section, the four quadrants of the abdomen were listened to every hour for the first 12 hours and every 4 hours for the next 12 hours by the investigator, and the first bowel sound time was determined by the investigator.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>First gas output, first defecation output, nausea and vomiting by the patient's statement checklist</measure>
      <time_frame>24 hours</time_frame>
      <description>Nausea, vomiting, first gas and first defecation times were determined by the patient's statement.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">77</enrollment>
    <condition>COFFEE</condition>
    <condition>Gastrointestinal Motility and Defecation Conditions</condition>
    <arm_group>
      <arm_group_label>Coffee group (Group 1)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Then, at the 4th hour, 8th hour and 12th hour of the surgery, the patients in the coffee group received 10 gr. granulated coffee.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hot water group (Group 2)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients in the hot water group were given 200 ml of 50-60 C0 sugar-free hot water at the 4th hour, 8th hour and 12th hour of the operation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group (Group 3)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No application was made to the control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Coffee</intervention_name>
      <description>4th hour, 8th hour and 12th hour of after the surgery, the patients in the coffee group received 10 gr. granulated coffee.</description>
      <arm_group_label>Coffee group (Group 1)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hot water</intervention_name>
      <description>hot water group were given 200 ml of 50-60 C0 sugar-free hot water at the 4th hour, 8th hour and 12th hour of after the operation</description>
      <arm_group_label>Hot water group (Group 2)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Cesarean section performed by the physician determined in the research&#xD;
  &#xD;
            -  Over 18 years old,&#xD;
  &#xD;
            -  Completing the 37. gestational week,&#xD;
  &#xD;
            -  Do not have any gastrointestinal system disease that may affect the results of the&#xD;
               research and do not use drugs,&#xD;
  &#xD;
            -  Able to understand and speak Turkish,&#xD;
  &#xD;
            -  Women who voluntarily participated in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cesarean section performed by a different physician than the physician determined in&#xD;
               the study.&#xD;
  &#xD;
            -  Younger than 18,&#xD;
  &#xD;
            -  Not completing the 37.gestational week&#xD;
  &#xD;
            -  Having any gastrointestinal system disease that may affect the research results and&#xD;
               using medication&#xD;
  &#xD;
            -  Can't understand or speak Turkish.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Cesarean section is performed only on women.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Mersin University</name>
        <address>
          <city>Mersin</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mersin University</investigator_affiliation>
      <investigator_full_name>Seher Gürdil Yılmaz</investigator_full_name>
      <investigator_title>Lecturer doctor</investigator_title>
    </responsible_party>
    <keyword>cesarean section</keyword>
    <keyword>coffee</keyword>
    <keyword>bowel sound</keyword>
    <keyword>flatulence</keyword>
    <!-- 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/NCT05980975
  org study id: MersinUniversityy
  nct id: NCT05980975
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to examine the effects of coffee and hot water consumption on
        gastrointestinal system functions after cesarean section performed under general anesthesia.
        The study is in a randomized controlled experimental design.
  
        The sample of the study consisted of 25 participants in the coffee group (Group 1), 26
        participants in the hot water group (Group 2) and 27 participants in the control group (Group
        3). After cesarean section, at the 4th, 8th and 12th hours of the operation, the first
        intervention group (coffee group) received 2 gr. granulated coffee, the second intervention
        group (hot water group) was given 100 ml of 50-60 C0 sugar-free hot water, the third group
        (control group) was given no intervention other than routine applications.
  Objective: The aim of this study is to examine the effects of coffee and hot water
        consumption on gastrointestinal system functions after cesarean section performed under
        general anesthesia.
  
        Materials and Methods: The study is in a randomized controlled experimental design. Patients
        who had an uncomplicated cesarean section under general anesthesia, were older than 18 years
        of age, completed the 37th week of pregnancy, did not have any gastrointestinal system
        disease that could affect the results of the study, and did not use drugs, and who could
        understand and speak Turkish were included in the study. The sample of the study consisted of
        25 participants in the coffee group (Group 1), 26 participants in the hot water group (Group
        2) and 27 participants in the control group (Group 3). After cesarean section, at the 4th,
        8th and 12th hours of the operation, the first intervention group (coffee group) received 2
        gr. granulated coffee, the second intervention group (hot water group) was given 100 ml of
        50-60 C0 sugar-free hot water, the third group (control group) was given no intervention
        other than routine applications.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  measure: First bowel sound time listened with stethoscope
  time frame: 24 hours
  description: After cesarean section, the four quadrants of the abdomen were listened to every hour for the first 12 hours and every 4 hours for the next 12 hours by the investigator, and the first bowel sound time was determined by the investigator.
  measure: First gas output, first defecation output, nausea and vomiting by the patient's statement checklist
  time frame: 24 hours
  description: Nausea, vomiting, first gas and first defecation times were determined by the patient's statement.
  arm group label: Coffee group (Group 1)
  arm group type: Experimental
  description: Then, at the 4th hour, 8th hour and 12th hour of the surgery, the patients in the coffee group received 10 gr. granulated coffee.
  arm group label: Hot water group (Group 2)
  arm group type: Experimental
  description: The patients in the hot water group were given 200 ml of 50-60 C0 sugar-free hot water at the 4th hour, 8th hour and 12th hour of the operation.
  arm group label: Control group (Group 3)
  arm group type: No Intervention
  description: No application was made to the control group.
  intervention type: Other
  intervention name: Coffee
  description: 4th hour, 8th hour and 12th hour of after the surgery, the patients in the coffee group received 10 gr. granulated coffee.
  arm group label: Coffee group (Group 1)
  intervention type: Other
  intervention name: Hot water
  description: hot water group were given 200 ml of 50-60 C0 sugar-free hot water at the 4th hour, 8th hour and 12th hour of after the operation
  arm group label: Hot water group (Group 2)
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Cesarean section is performed only on women.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Mersin University
  investigator full name: Seher Gürdil Yılmaz
  investigator title: Lecturer doctor