<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/NCT03236623</url>
  </required_header>
  <id_info>
    <org_study_id>7289</org_study_id>
    <nct_id>NCT03236623</nct_id>
  </id_info>
  <brief_title>Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period.</brief_title>
  <official_title>The Use of the Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade Estadual de Londrina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</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>
      Thirst is defined as the desire to drink water. The perception and satiation of thirst&#xD;
      constitute an interconnected network of neuronal, physiological and hormonal mechanisms that&#xD;
      act simultaneously. In the oropharyngeal cavity are ionic channels called Transient Receptor&#xD;
      Potential Melastatin 8 stimulated by cold temperatures and menthol, which aid in the control&#xD;
      and decrease of the thirst intensity for providing refreshment and satiety without, however,&#xD;
      the necessity of fluid intake In high amounts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thus, the present study aims to: compare the intensity and discomfort of thirst in the use of&#xD;
      the menthol popsicle and usual care in patients in the preoperative period. This is a&#xD;
      randomized clinical trial, to be performed in a public tertiary hospital. The sample size&#xD;
      calculation will be performed after the pilot test is conducted. Two groups will be formed&#xD;
      through randomization. The tested intervention consists of the menthol popsicle (experimental&#xD;
      group). The thirst intensity (primary outcome) will be measured by means of the Numerical&#xD;
      Scale and the discomfort of thirst (secondary outcome) through the Perioperative Seat&#xD;
      Discomfort Scale, in two moments: at the end of the first approach of the patient and 20&#xD;
      minutes after the intervention. The results of this research may support the decision-making&#xD;
      of health professionals in the implementation of effective and safe actions to manage the&#xD;
      seat of the surgical patient in the preoperative period. Another relevant aspect is the&#xD;
      production of knowledge about the problem, which is scarce both in the national and&#xD;
      international scenario.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Anticipated">November 26, 2017</completion_date>
  <primary_completion_date type="Actual">September 26, 2017</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>
    <intervention_model_description>This is a study with an experimental research design, such as a randomizedclinical trial, parallel, prospective and monocentric.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of thirst</measure>
    <time_frame>Measured at the beginning of the survey. For the experimental group, this measurement was measured again 20 minutes after tasting the menthol popsicle. For the control group, this measure was re-measured 20 minutes after the randomization.</time_frame>
    <description>Measured from zero to ten, where zero is no thirst and ten worst thirst.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discomfort of thirst.</measure>
    <time_frame>Measured at the beginning of the survey. For the experimental group, this measurement was measured again 20 minutes after tasting the menthol popsicle. For the control group, this measure was re-measured 20 minutes after the randomization.</time_frame>
    <description>Measured according to the Perioperative Headquarters Discomfort Scale (EDESP). The final EDESP score ranges from zero to 14 points, 14 of which correspond to the most intense discomfort related to the perioperative seat.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Thirst</condition>
  <condition>Perioperative Nursing</condition>
  <arm_group>
    <arm_group_label>Menthol Popsicle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will be questioned when the intensity and discomfort of thirst. After randomization, the patient assigned to the experimental group will experience a menthol popsicle. After 20 minutes of the end of the popsicle, will again be questioned as to the intensity and discomfort of thirst. The popsicle will have a support that will assist the patient in the administration of the intervention, giving him autonomy and safety in the application of the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patient will be questioned when the intensity and discomfort of thirst. After randomization, the patient assigned to the control group should receive the usual care consisting of absolute fasting the food and drinks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Menthol Popsicle</intervention_name>
    <description>The menthol popsicle composed of 0.05% menthol, 0.05% saccharin, 30ml ultrafiltered water and 2% cereal alcohol. The popsicle will have a support that will assist the patient in the administration of the intervention, giving him autonomy and safety in the application of the intervention.</description>
    <arm_group_label>Menthol Popsicle</arm_group_label>
    <other_name>Menthol Ice</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 60 years;&#xD;
&#xD;
          -  Without the use of pre-anesthetic medication, until the moment of data collection;&#xD;
&#xD;
          -  Conscious and alert, who recognizes himself and responds to the stimuli of the&#xD;
             environment;&#xD;
&#xD;
          -  Oriented in relation to time and space;&#xD;
&#xD;
          -  Fasting for more than two hours at the time of data collection;&#xD;
&#xD;
          -  Minimum time of three hours prior to the scheduled time for surgery, to approach and&#xD;
             collect data;&#xD;
&#xD;
          -  Report thirst.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presenting a contraindication of ingestion or swallowing;&#xD;
&#xD;
          -  Present mandibular trauma;&#xD;
&#xD;
          -  Being nauseated or vomiting;&#xD;
&#xD;
          -  Refer to allergy to mentha;&#xD;
&#xD;
          -  In dialysis;&#xD;
&#xD;
          -  Report sjogren's syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Aroni</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aroni</last_name>
    <phone>+5543999761025</phone>
    <email>aronipatricia@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Patricia Aroni</name>
      <address>
        <city>Londrina</city>
        <state>Paraná</state>
        <zip>86047160</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Aroni</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Patricia Aroni</investigator_full_name>
    <investigator_title>researcher</investigator_title>
  </responsible_party>
  <keyword>Surgical Patient</keyword>
  <keyword>Menthol</keyword>
  <keyword>Clinical Study</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menthol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03236623
org study id: 7289
nct id: NCT03236623
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thirst is defined as the desire to drink water. The perception and satiation of thirst
      constitute an interconnected network of neuronal, physiological and hormonal mechanisms that
      act simultaneously. In the oropharyngeal cavity are ionic channels called Transient Receptor
      Potential Melastatin 8 stimulated by cold temperatures and menthol, which aid in the control
      and decrease of the thirst intensity for providing refreshment and satiety without, however,
      the necessity of fluid intake In high amounts.
Thus, the present study aims to: compare the intensity and discomfort of thirst in the use of
      the menthol popsicle and usual care in patients in the preoperative period. This is a
      randomized clinical trial, to be performed in a public tertiary hospital. The sample size
      calculation will be performed after the pilot test is conducted. Two groups will be formed
      through randomization. The tested intervention consists of the menthol popsicle (experimental
      group). The thirst intensity (primary outcome) will be measured by means of the Numerical
      Scale and the discomfort of thirst (secondary outcome) through the Perioperative Seat
      Discomfort Scale, in two moments: at the end of the first approach of the patient and 20
      minutes after the intervention. The results of this research may support the decision-making
      of health professionals in the implementation of effective and safe actions to manage the
      seat of the surgical patient in the preoperative period. Another relevant aspect is the
      production of knowledge about the problem, which is scarce both in the national and
      international scenario.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a study with an experimental research design, such as a randomizedclinical trial, parallel, prospective and monocentric.
primary purpose: Treatment
masking: None (Open Label)
measure: Intensity of thirst
time frame: Measured at the beginning of the survey. For the experimental group, this measurement was measured again 20 minutes after tasting the menthol popsicle. For the control group, this measure was re-measured 20 minutes after the randomization.
description: Measured from zero to ten, where zero is no thirst and ten worst thirst.
measure: Discomfort of thirst.
time frame: Measured at the beginning of the survey. For the experimental group, this measurement was measured again 20 minutes after tasting the menthol popsicle. For the control group, this measure was re-measured 20 minutes after the randomization.
description: Measured according to the Perioperative Headquarters Discomfort Scale (EDESP). The final EDESP score ranges from zero to 14 points, 14 of which correspond to the most intense discomfort related to the perioperative seat.
arm group label: Menthol Popsicle
arm group type: Experimental
description: The patient will be questioned when the intensity and discomfort of thirst. After randomization, the patient assigned to the experimental group will experience a menthol popsicle. After 20 minutes of the end of the popsicle, will again be questioned as to the intensity and discomfort of thirst. The popsicle will have a support that will assist the patient in the administration of the intervention, giving him autonomy and safety in the application of the intervention.
arm group label: Usual care
arm group type: No Intervention
description: The patient will be questioned when the intensity and discomfort of thirst. After randomization, the patient assigned to the control group should receive the usual care consisting of absolute fasting the food and drinks.
intervention type: Other
intervention name: Menthol Popsicle
description: The menthol popsicle composed of 0.05% menthol, 0.05% saccharin, 30ml ultrafiltered water and 2% cereal alcohol. The popsicle will have a support that will assist the patient in the administration of the intervention, giving him autonomy and safety in the application of the intervention.
arm group label: Menthol Popsicle
other name: Menthol Ice
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Patricia Aroni
role: Principal Investigator
affiliation: University of São Paulo
last name: Aroni
phone: +5543999761025
email: aronipatricia@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Patricia Aroni
investigator title: researcher
mesh term: Menthol
sharing ipd: No