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/NCT05990140</url>
    </required_header>
    <id_info>
      <org_study_id>Vesile23</org_study_id>
      <nct_id>NCT05990140</nct_id>
    </id_info>
    <brief_title>The Effect of Peppermint Flavored Mouthwash Applied to Patients</brief_title>
    <official_title>The Effect of Peppermint Flavored Mouthwash Applied to Patients in the First 30 Days After Bariatric Surgery on Nausea-Vomiting, Anxiety and Biochemical Parameters</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ataturk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ataturk University</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>
        Treatment of obesity consists of diet/lifestyle modification and bariatric surgery consisting&#xD;
        of several procedures. One of the most common complications in the early period after&#xD;
        bariatric surgery is nausea and vomiting due to the reduction of gastric capacity. According&#xD;
        to the guidelines of the American Society of Metabolic and Bariatric Surgery (ASMBS),&#xD;
        acid-base disorders, electrolyte abnormalities (especially calcium, potassium, magnesium,&#xD;
        sodium and phosphorus deficiency), insufficiency of fat-soluble vitamins (ADEK), folic acid,&#xD;
        iron, thiamine after bariatric surgery. and B12 deficiency etc. On the other hand, anxiety&#xD;
        after bariatric surgery is also an important problem.&#xD;
  &#xD;
        It is possible to reduce nausea and vomiting by stimulating the vagal nerve. Gargling,&#xD;
        laughing, singing loudly, etc. The movements stimulate the vagus nerve by activating the&#xD;
        muscles behind the larynx, and the vagus nerve prevents nausea and vomiting by simulating the&#xD;
        gastrointestinal tract. With the activation of the diaphragm; The vagus nerve is stimulated,&#xD;
        the parasympathetic nervous system is activated and cortisol production decreases, reducing&#xD;
        stress and anxiety. The peppermint plant, which is widely used in our country, is also used&#xD;
        as a relief in cases such as nausea, stomachache, and colds. It is expected that the nurse,&#xD;
        who is a member of the multidisciplinary team, will be able to properly define the surgical&#xD;
        risks and comorbidities associated with the clinical status of obesity in patients who have&#xD;
        undergone bariatric surgery and to apply the necessary interventions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">July 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 12, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>State-Trait Anxiety Inventory</measure>
      <time_frame>up to 1 month</time_frame>
      <description>This inventory consists of two separate sections. consists of 40 questions in total. General temperament of the person in 20 questions in the continuous section While the state is evaluated, how the person feels at that moment is evaluated in the state section. Continually Anxiety is an individual's tendency to experience anxiety. State anxiety is the stressful situation in which the individual is It is the subjective fear felt by the situation. While it rises when the stress is intense, the stress In cases where the level of anxiety decreases, the State-Trait Anxiety Inventory score decreases. Inventory While filling, one of the 4 options is preferred; scores are added together and high scores are shows anxiety levels</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Nausea Vomiting Visual Comparison Scale</measure>
      <time_frame>up to 1 month</time_frame>
      <description>It is a scale that evaluates the severity of nausea of the participants on a 10-centimeter ruler with &quot;0&quot; on the left end, no nausea at all, and &quot;100&quot; on the right end as the most severe nausea (unbearable nausea).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determination of Levels of Biochemical Parameters in Blood</measure>
      <time_frame>up to 1 month</time_frame>
      <description>Laboratory results obtained routinely in the hospital where the study will be conducted will be used.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Postoperative Complications</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Consent of all patients will be obtained the night before surgery. Biochemical parameter levels and state trait anxiety scale and apfel risk scale will be recorded.&#xD;
  As it will be difficult for the experimental group to be oriented while giving mouthwash training after the surgery, mouthwash training will be given at a time when it is available the night before the operation. State anxiety scale, visual comparison scale and nausea and vomiting effect scale will be administered before discharge (approximately 48 hours). After discharge, he will continue to gargle in the same way 3 times a day. At the end of the first week, all patients will be called by the researcher and the state anxiety scale, visual comparison scale and nausea and vomiting effect scale shared on the digital environment will be filled and recorded. This process will continue for 4 weeks. In the last measurement, visual comparison scale, nausea vomiting and state trait anxiety scale will also be filled.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Consent of all patients will be obtained the night before surgery. Biochemical parameter levels and state trait anxiety scale and apfel risk scale will be recorded.&#xD;
  The state anxiety scale, visual comparison scale and nausea and vomiting effect scale will be administered to the control group before they are discharged (approximately at the 48th hour). At the end of the first week, all patients will be called by the researcher, and the state anxiety scale, visual comparison scale and nausea and vomiting effect scale will be filled and recorded. This process will continue for 4 weeks. In the last measurement, visual comparison scale, nausea vomiting and state trait anxiety scale will also be filled. At the end of the first month, the biochemical parameters taken during the routine hospital control will be recorded.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>peppermint flavored mouthwash</intervention_name>
      <description>The Effect of Peppermint Flavored Mouthwash Applied to Patients in the First 30 Days After Bariatric Surgery on Nausea-Vomiting, Anxiety and Biochemical Parameters</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Be between the ages of 18-65&#xD;
  &#xD;
            2. Having had bariatric surgery&#xD;
  &#xD;
            3. Absence of communication barriers&#xD;
  &#xD;
            4. Volunteering to participate in research&#xD;
  &#xD;
            5. Mental well-being&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Presence of major depression or psychosis&#xD;
  &#xD;
            2. Having a communication barrier&#xD;
  &#xD;
            3. Being transferred to another unit&#xD;
  &#xD;
            4. Leaving work voluntarily&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vesile Eskici İlgin, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ataturk University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vesile Eskici İlgin, Dr</last_name>
      <phone>05057820893</phone>
      <email>vesile_eskici_86@hotmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ataturk University</investigator_affiliation>
      <investigator_full_name>Vesile Eskici Ilgin</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>nausea-vomiting</keyword>
    <keyword>anxiety</keyword>
    <keyword>nurse</keyword>
    <keyword>Biochemical Parameters</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Postoperative Complications</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05990140
  org study id: Vesile23
  nct id: NCT05990140
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Treatment of obesity consists of diet/lifestyle modification and bariatric surgery consisting
        of several procedures. One of the most common complications in the early period after
        bariatric surgery is nausea and vomiting due to the reduction of gastric capacity. According
        to the guidelines of the American Society of Metabolic and Bariatric Surgery (ASMBS),
        acid-base disorders, electrolyte abnormalities (especially calcium, potassium, magnesium,
        sodium and phosphorus deficiency), insufficiency of fat-soluble vitamins (ADEK), folic acid,
        iron, thiamine after bariatric surgery. and B12 deficiency etc. On the other hand, anxiety
        after bariatric surgery is also an important problem.
  
        It is possible to reduce nausea and vomiting by stimulating the vagal nerve. Gargling,
        laughing, singing loudly, etc. The movements stimulate the vagus nerve by activating the
        muscles behind the larynx, and the vagus nerve prevents nausea and vomiting by simulating the
        gastrointestinal tract. With the activation of the diaphragm; The vagus nerve is stimulated,
        the parasympathetic nervous system is activated and cortisol production decreases, reducing
        stress and anxiety. The peppermint plant, which is widely used in our country, is also used
        as a relief in cases such as nausea, stomachache, and colds. It is expected that the nurse,
        who is a member of the multidisciplinary team, will be able to properly define the surgical
        risks and comorbidities associated with the clinical status of obesity in patients who have
        undergone bariatric surgery and to apply the necessary interventions.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: State-Trait Anxiety Inventory
  time frame: up to 1 month
  description: This inventory consists of two separate sections. consists of 40 questions in total. General temperament of the person in 20 questions in the continuous section While the state is evaluated, how the person feels at that moment is evaluated in the state section. Continually Anxiety is an individual's tendency to experience anxiety. State anxiety is the stressful situation in which the individual is It is the subjective fear felt by the situation. While it rises when the stress is intense, the stress In cases where the level of anxiety decreases, the State-Trait Anxiety Inventory score decreases. Inventory While filling, one of the 4 options is preferred; scores are added together and high scores are shows anxiety levels
  measure: Nausea Vomiting Visual Comparison Scale
  time frame: up to 1 month
  description: It is a scale that evaluates the severity of nausea of the participants on a 10-centimeter ruler with "0" on the left end, no nausea at all, and "100" on the right end as the most severe nausea (unbearable nausea).
  measure: Determination of Levels of Biochemical Parameters in Blood
  time frame: up to 1 month
  description: Laboratory results obtained routinely in the hospital where the study will be conducted will be used.
  arm group label: Experimental
  arm group type: Experimental
  description: Consent of all patients will be obtained the night before surgery. Biochemical parameter levels and state trait anxiety scale and apfel risk scale will be recorded.
  As it will be difficult for the experimental group to be oriented while giving mouthwash training after the surgery, mouthwash training will be given at a time when it is available the night before the operation. State anxiety scale, visual comparison scale and nausea and vomiting effect scale will be administered before discharge (approximately 48 hours). After discharge, he will continue to gargle in the same way 3 times a day. At the end of the first week, all patients will be called by the researcher and the state anxiety scale, visual comparison scale and nausea and vomiting effect scale shared on the digital environment will be filled and recorded. This process will continue for 4 weeks. In the last measurement, visual comparison scale, nausea vomiting and state trait anxiety scale will also be filled.
  arm group label: Control
  arm group type: No Intervention
  description: Consent of all patients will be obtained the night before surgery. Biochemical parameter levels and state trait anxiety scale and apfel risk scale will be recorded.
  The state anxiety scale, visual comparison scale and nausea and vomiting effect scale will be administered to the control group before they are discharged (approximately at the 48th hour). At the end of the first week, all patients will be called by the researcher, and the state anxiety scale, visual comparison scale and nausea and vomiting effect scale will be filled and recorded. This process will continue for 4 weeks. In the last measurement, visual comparison scale, nausea vomiting and state trait anxiety scale will also be filled. At the end of the first month, the biochemical parameters taken during the routine hospital control will be recorded.
  intervention type: Other
  intervention name: peppermint flavored mouthwash
  description: The Effect of Peppermint Flavored Mouthwash Applied to Patients in the First 30 Days After Bariatric Surgery on Nausea-Vomiting, Anxiety and Biochemical Parameters
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Vesile Eskici İlgin, Dr
  role: Principal Investigator
  affiliation: Ataturk University
  last name: Vesile Eskici İlgin, Dr
  phone: 05057820893
  email: vesile_eskici_86@hotmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Ataturk University
  investigator full name: Vesile Eskici Ilgin
  investigator title: Principal Investigator
  mesh term: Postoperative Complications
  sharing ipd: No