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/NCT06008262</url>
    </required_header>
    <id_info>
      <org_study_id>E-81477236-604.01.01-1666</org_study_id>
      <nct_id>NCT06008262</nct_id>
    </id_info>
    <brief_title>Cold Application Effects on Nausea and Vomiting After Laparoscopic Cholecystectomy</brief_title>
    <official_title>The Effect of Cold Application on Nausea and Vomiting After Laparoscopic Cholecystectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara Medipol University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara Medipol 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>
        This clinical trial aims to test the effect of cold application on postoperative nausea and&#xD;
        vomiting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nausea and vomiting seen within the first 24 hours after surgery are defined as&#xD;
        &quot;Post-Operative Nausea and Vomiting (POBK). Postoperative nausea and vomiting are one of the&#xD;
        most common complications of anesthesia. It has been reported that the risk of nausea and&#xD;
        vomiting is particularly high after laparoscopic cholecystectomy. It is stated that vagal&#xD;
        stimulation and pneumoperitoneum process may trigger this situation in laparoscopic&#xD;
        surgeries. Nausea and vomiting after surgery is a very uncomfortable situation for the&#xD;
        patient. There are several pharmacological methods to prevent and treat POBK. However, it is&#xD;
        stated that the non-pharmacological approach should also be brought to the fore. It is stated&#xD;
        that cold reduces molecular activity and causes vasoconstriction. It is stated that cold can&#xD;
        slow down the blood flow to the vomiting center in the medulla oblongata and the progression&#xD;
        of nausea and vomiting can be slowed down. In this way, it is thought that it will contribute&#xD;
        to increasing patient satisfaction and providing cost-effective care.&#xD;
  &#xD;
        The study will conduct as a prospective randomized controlled trial. After obtaining verbal&#xD;
        and written consent from the patients before and after the surgery, the study will conduct&#xD;
        with various data collection forms.&#xD;
  &#xD;
        These forms are; the patient data collection form, numerical evaluation scale, preoperative&#xD;
        Apfel risk score evaluation form, postoperative nausea severity evaluation form, and&#xD;
        perceived effectiveness of the ice pack forms will use. Laparoscopic cholecystectomy will&#xD;
        perform and all cases meeting the inclusion criteria will evaluate. Patients will randomize.&#xD;
        The ice pack will apply in group-I (n=27), and group II (n=27) will be the control group. An&#xD;
        ice pack will be applied to the posterior upper neck regions of patients with nausea in&#xD;
        Group-I, at an interval of 5 minutes. The vital signs of the patients will be recorded. The&#xD;
        severity of nausea and pain of the patients will be evaluated with a numerical rating scale.&#xD;
        The effectiveness of its application as perceived by the patient will be evaluated.&#xD;
  &#xD;
        In the control group, the severity of nausea and pain will be determined by using a numerical&#xD;
        evaluation scale in patients with postoperative nausea. Vital signs will be recorded at this&#xD;
        stage. Standard procedures will be applied to these patients within the scope of nursing&#xD;
        practices.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">July 3, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from postoperative nausea degree in a 15 minutes</measure>
      <time_frame>Within 15 minutes of first sense of postoperative nausea</time_frame>
      <description>In this section, the degree of postoperative nausea will decrease or disappear. This status will evaluate with Numerical Evaluation Scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from postoperative vomiting in a 15 minutes</measure>
      <time_frame>Within 15 minutes of first sense of postoperative nausea</time_frame>
      <description>In this section, postoperative vomiting will not occur. This status will evaluate with yes/no question.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of cold application effectiveness</measure>
      <time_frame>Within 15 minutes of first sense of postoperative nausea</time_frame>
      <description>In this section, the effectiveness of cold application with a Ice Pack Perceived Effectiveness Form. In this form, there are three different expressions as the application reduced nausea, did not affect nausea, increased nausea.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Laparoscopic Cholecystectomy</condition>
    <condition>Postoperative Nausea and Vomiting</condition>
    <arm_group>
      <arm_group_label>Cold Application Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>An ice pack will be applied to the posterior upper neck regions of patients with nausea in Group-I, with an interval of 5 minutes. The vital signs of the patients will be recorded. The severity of nausea and pain of the patients will be evaluated with a numerical rating scale. The effectiveness of its application as perceived by the patient will be evaluated.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>In the control group, the severity of nausea and pain will be determined by using a numerical evaluation scale in patients with postoperative nausea. Vital signs will be recorded at this stage. Normal procedures will be applied to these patients within the scope of nursing practices.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cold Application</intervention_name>
      <description>An ice pack will be applied to the posterior upper neck regions of patients with nausea in Group-I, with an interval of 5 minutes. The vital signs of the patients will be recorded. The severity of nausea and pain of the patients will be evaluated with a numerical rating scale. The effectiveness of its application as perceived by the patient will be evaluated.</description>
      <arm_group_label>Cold Application Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion in ASA (American Society of Anesthesiologists) I-II-III class&#xD;
  &#xD;
            -  Being over 18 years old&#xD;
  &#xD;
            -  Having received general anesthesia&#xD;
  &#xD;
            -  Preoperative pain value of 6 or less&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe nausea in the preoperative period&#xD;
  &#xD;
            -  Being hypothermic in the postoperative period&#xD;
  &#xD;
            -  Having had head and neck surgery&#xD;
  &#xD;
            -  Taking prophylactic antiemetics&#xD;
  &#xD;
            -  Postoperative pain value of 7 and above&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Neslihan Ilkaz, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ankara Medipol University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Neslihan Ilkaz</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Son JS, Oh JY, Ko S. Effects of hypercapnia on postoperative nausea and vomiting after laparoscopic surgery: a double-blind randomized controlled study. Surg Endosc. 2017 Nov;31(11):4576-4582. doi: 10.1007/s00464-017-5519-8. Epub 2017 Apr 7.</citation>
      <PMID>28389799</PMID>
    </reference>
    <reference>
      <citation>Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833. Erratum In: Anesth Analg. 2020 Nov;131(5):e241.</citation>
      <PMID>32467512</PMID>
    </reference>
    <reference>
      <citation>Hooper VD. SAMBA Consensus Guidelines for the Management of Postoperative Nausea and Vomiting: An Executive Summary for Perianesthesia Nurses. J Perianesth Nurs. 2015 Oct;30(5):377-82. doi: 10.1016/j.jopan.2015.08.009. No abstract available.</citation>
      <PMID>26408511</PMID>
    </reference>
    <reference>
      <citation>Scharfenberg DR, Salcido A, Malone P, Clark J, Steele MA. Managing Postoperative Nausea With an Application of Ice Pack to the Posterior Upper Neck. J Perianesth Nurs. 2022 Dec;37(6):774-777. doi: 10.1016/j.jopan.2021.12.010. Epub 2022 May 28.</citation>
      <PMID>35637077</PMID>
    </reference>
    <reference>
      <citation>Hymel N, Davies M. Evidence-Based Antiemetic Decision Tool for Management of Postoperative Nausea and Vomiting in Patients at High Risk of QT Prolongation and Patients Receiving Neurotransmitter-Modulating Medications. AANA J. 2020 Aug;88(4):312-318.</citation>
      <PMID>32718430</PMID>
    </reference>
    <reference>
      <citation>American Society of PeriAnesthesia Nurses PONV/PDNV Strategic Work Team. ASPAN'S evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J Perianesth Nurs. 2006 Aug;21(4):230-50. doi: 10.1016/j.jopan.2006.06.003. No abstract available.</citation>
      <PMID>16935735</PMID>
    </reference>
    <reference>
      <citation>Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494.</citation>
      <PMID>24356162</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara Medipol University</investigator_affiliation>
      <investigator_full_name>Neslihan Ilkaz</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Laparoscopic cholecystectomy</keyword>
    <keyword>Postoperative Nausea and Vomiting</keyword>
    <keyword>Cold application</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nausea</mesh_term>
      <mesh_term>Vomiting</mesh_term>
      <mesh_term>Postoperative Nausea and Vomiting</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/NCT06008262
  org study id: E-81477236-604.01.01-1666
  nct id: NCT06008262
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial aims to test the effect of cold application on postoperative nausea and
        vomiting.
  Nausea and vomiting seen within the first 24 hours after surgery are defined as
        "Post-Operative Nausea and Vomiting (POBK). Postoperative nausea and vomiting are one of the
        most common complications of anesthesia. It has been reported that the risk of nausea and
        vomiting is particularly high after laparoscopic cholecystectomy. It is stated that vagal
        stimulation and pneumoperitoneum process may trigger this situation in laparoscopic
        surgeries. Nausea and vomiting after surgery is a very uncomfortable situation for the
        patient. There are several pharmacological methods to prevent and treat POBK. However, it is
        stated that the non-pharmacological approach should also be brought to the fore. It is stated
        that cold reduces molecular activity and causes vasoconstriction. It is stated that cold can
        slow down the blood flow to the vomiting center in the medulla oblongata and the progression
        of nausea and vomiting can be slowed down. In this way, it is thought that it will contribute
        to increasing patient satisfaction and providing cost-effective care.
  
        The study will conduct as a prospective randomized controlled trial. After obtaining verbal
        and written consent from the patients before and after the surgery, the study will conduct
        with various data collection forms.
  
        These forms are; the patient data collection form, numerical evaluation scale, preoperative
        Apfel risk score evaluation form, postoperative nausea severity evaluation form, and
        perceived effectiveness of the ice pack forms will use. Laparoscopic cholecystectomy will
        perform and all cases meeting the inclusion criteria will evaluate. Patients will randomize.
        The ice pack will apply in group-I (n=27), and group II (n=27) will be the control group. An
        ice pack will be applied to the posterior upper neck regions of patients with nausea in
        Group-I, at an interval of 5 minutes. The vital signs of the patients will be recorded. The
        severity of nausea and pain of the patients will be evaluated with a numerical rating scale.
        The effectiveness of its application as perceived by the patient will be evaluated.
  
        In the control group, the severity of nausea and pain will be determined by using a numerical
        evaluation scale in patients with postoperative nausea. Vital signs will be recorded at this
        stage. Standard procedures will be applied to these patients within the scope of nursing
        practices.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change from postoperative nausea degree in a 15 minutes
  time frame: Within 15 minutes of first sense of postoperative nausea
  description: In this section, the degree of postoperative nausea will decrease or disappear. This status will evaluate with Numerical Evaluation Scale.
  measure: Change from postoperative vomiting in a 15 minutes
  time frame: Within 15 minutes of first sense of postoperative nausea
  description: In this section, postoperative vomiting will not occur. This status will evaluate with yes/no question.
  measure: Evaluation of cold application effectiveness
  time frame: Within 15 minutes of first sense of postoperative nausea
  description: In this section, the effectiveness of cold application with a Ice Pack Perceived Effectiveness Form. In this form, there are three different expressions as the application reduced nausea, did not affect nausea, increased nausea.
  arm group label: Cold Application Group
  arm group type: Experimental
  description: An ice pack will be applied to the posterior upper neck regions of patients with nausea in Group-I, with an interval of 5 minutes. The vital signs of the patients will be recorded. The severity of nausea and pain of the patients will be evaluated with a numerical rating scale. The effectiveness of its application as perceived by the patient will be evaluated.
  arm group label: Control Group
  arm group type: No Intervention
  description: In the control group, the severity of nausea and pain will be determined by using a numerical evaluation scale in patients with postoperative nausea. Vital signs will be recorded at this stage. Normal procedures will be applied to these patients within the scope of nursing practices.
  intervention type: Other
  intervention name: Cold Application
  description: An ice pack will be applied to the posterior upper neck regions of patients with nausea in Group-I, with an interval of 5 minutes. The vital signs of the patients will be recorded. The severity of nausea and pain of the patients will be evaluated with a numerical rating scale. The effectiveness of its application as perceived by the patient will be evaluated.
  arm group label: Cold Application Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Neslihan Ilkaz, PhD
  role: Principal Investigator
  affiliation: Ankara Medipol University
  facility: 
  country: Turkey
  citation: Son JS, Oh JY, Ko S. Effects of hypercapnia on postoperative nausea and vomiting after laparoscopic surgery: a double-blind randomized controlled study. Surg Endosc. 2017 Nov;31(11):4576-4582. doi: 10.1007/s00464-017-5519-8. Epub 2017 Apr 7.
  PMID: 28389799
  citation: Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833. Erratum In: Anesth Analg. 2020 Nov;131(5):e241.
  PMID: 32467512
  citation: Hooper VD. SAMBA Consensus Guidelines for the Management of Postoperative Nausea and Vomiting: An Executive Summary for Perianesthesia Nurses. J Perianesth Nurs. 2015 Oct;30(5):377-82. doi: 10.1016/j.jopan.2015.08.009. No abstract available.
  PMID: 26408511
  citation: Scharfenberg DR, Salcido A, Malone P, Clark J, Steele MA. Managing Postoperative Nausea With an Application of Ice Pack to the Posterior Upper Neck. J Perianesth Nurs. 2022 Dec;37(6):774-777. doi: 10.1016/j.jopan.2021.12.010. Epub 2022 May 28.
  PMID: 35637077
  citation: Hymel N, Davies M. Evidence-Based Antiemetic Decision Tool for Management of Postoperative Nausea and Vomiting in Patients at High Risk of QT Prolongation and Patients Receiving Neurotransmitter-Modulating Medications. AANA J. 2020 Aug;88(4):312-318.
  PMID: 32718430
  citation: American Society of PeriAnesthesia Nurses PONV/PDNV Strategic Work Team. ASPAN'S evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J Perianesth Nurs. 2006 Aug;21(4):230-50. doi: 10.1016/j.jopan.2006.06.003. No abstract available.
  PMID: 16935735
  citation: Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494.
  PMID: 24356162
  responsible party type: Principal Investigator
  investigator affiliation: Ankara Medipol University
  investigator full name: Neslihan Ilkaz
  investigator title: Assistant Professor
  mesh term: Nausea
  mesh term: Vomiting
  mesh term: Postoperative Nausea and Vomiting