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/NCT06014216</url>
    </required_header>
    <id_info>
      <org_study_id>21/093/GHT</org_study_id>
      <nct_id>NCT06014216</nct_id>
    </id_info>
    <brief_title>Treating Post-Operative Thirst With Flavoured Ice Lollies or Water - a Comparative Study to Improve Post-operative Discomfort</brief_title>
    <acronym>THIRST</acronym>
    <official_title>Treating Post-Operative Thirst With Flavoured Ice Lollies or Water - a Comparative Study to Improve Post-operative Discomfort</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gloucestershire Hospitals NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gloucestershire Hospitals NHS Foundation Trust</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>
        Patients are asked not to eat and drink before their operation, and we know that this can&#xD;
        make people feel thirstier when they wake up from their anaesthetic. We want to know if&#xD;
        giving patients ice lollies improves their thirst more than if they were given water.&#xD;
        Gloucestershire Royal Hospital is funding and running a research study to find ways to try&#xD;
        and improve this.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The 2019 peri-operative quality improvement project (PQIP) run by the Royal College of&#xD;
        Anaesthetists showed 79% of patients experience moderate to severe thirst post-operatively.&#xD;
        As a significant source of post-operative discomfort, resolving patient thirst may&#xD;
        significantly improve their experience.&#xD;
  &#xD;
        Whilst provision of oral fluids may be able to alleviate some thirst, many patients are&#xD;
        unable to drink sufficient quantities to quench their thirst following an anaesthetic.&#xD;
        Furthermore, studies have shown that frozen water is able to quench thirst to a greater&#xD;
        degree than liquids.&#xD;
  &#xD;
        The purpose of this study is to determine whether ice lollies quench post-operative thirst to&#xD;
        a greater degree than water. Patients are already routinely offered water post-operatively,&#xD;
        the offering of flavoured ice lollies is a novel intervention for our hospital. We intend to&#xD;
        investigate two primary outcomes. First, can ice lollies quench post-operative thirst to a&#xD;
        greater degree than water and therefore improve patient discomfort. Second, if ice lollies&#xD;
        are found to be superior to water in quenching thirst and improving post-operative&#xD;
        discomfort, do these patients take less time to recover from their operation?&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 19, 2021</start_date>
    <completion_date type="Actual">May 17, 2021</completion_date>
    <primary_completion_date type="Actual">May 17, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The primary outcome measure is the level of post-operative thirst following intervention with either water or ice lolly.</measure>
      <time_frame>Intervention is to be given when the patient is adequately recovered from anaesthesia. An initial thirst score is recorded, then intervention given. Thirst scores are recorded again 15 minutes later to provide data for the primary outcome measure.</time_frame>
      <description>Data on pre and post-intervention thirst will be recorded using questionnaires and a numerical rating score from 0 to 10, with 0 being no thirst at all and 10 being very thirsty. These scores will also be sub-divided into no thirst (0), mild thirst (1-3), moderate thirst (4-7) and severe thirst (8-10). This data will undergo statistical analysis to challenge the null hypothesis for the primary outcome measure.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">173</enrollment>
    <condition>Postoperative Thirst</condition>
    <arm_group>
      <arm_group_label>Patients allocated ice lollies to treat post-operative thirst</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ice lollies consisted of a flavoured ice popsicle (blackcurrant) provided through hospital catering. Participants were allocated a single ice popsicle with thirst scores recored pre and post intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients allocated water as control comparison</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Water is a routine treatment for post-operative thirst and therefore used a control to compare our intervention against.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Flavoured ice lollies (popsicles)</intervention_name>
      <description>Blackcurrant flavoured ice popsicles, 105ml volume.</description>
      <arm_group_label>Patients allocated ice lollies to treat post-operative thirst</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Water</intervention_name>
      <description>Water from tap, one cup given by recovery nurses.</description>
      <arm_group_label>Patients allocated water as control comparison</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients over 18 years of age&#xD;
  &#xD;
            2. Patients attending for elective surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Allergy to products within the ice lolly&#xD;
  &#xD;
            2. Designated nil-by-mouth by anaesthetic or surgical teams&#xD;
  &#xD;
            3. Patient less than 18 years old&#xD;
  &#xD;
            4. Patient unable to give consent&#xD;
  &#xD;
            5. Refusal of patient to be involved with study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>David Sleep, BSc MSc MBBS D.Phil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gloucestershire Hospitals NHS Foundation Trust</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Gloucestershire Royal Hospital</name>
        <address>
          <city>Gloucester</city>
          <state>Gloucestershire</state>
          <zip>GL1 3NN</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Thirst</keyword>
    <keyword>Postoperative</keyword>
    <keyword>Ice Lollies</keyword>
    <keyword>Anaesthesia</keyword>
    <keyword>Hydration</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This is a small centre study with a minor intervention. Participant information is limited to demographic and operative data only.</ipd_description>
    </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/NCT06014216
  org study id: 21/093/GHT
  nct id: NCT06014216
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients are asked not to eat and drink before their operation, and we know that this can
        make people feel thirstier when they wake up from their anaesthetic. We want to know if
        giving patients ice lollies improves their thirst more than if they were given water.
        Gloucestershire Royal Hospital is funding and running a research study to find ways to try
        and improve this.
  The 2019 peri-operative quality improvement project (PQIP) run by the Royal College of
        Anaesthetists showed 79% of patients experience moderate to severe thirst post-operatively.
        As a significant source of post-operative discomfort, resolving patient thirst may
        significantly improve their experience.
  
        Whilst provision of oral fluids may be able to alleviate some thirst, many patients are
        unable to drink sufficient quantities to quench their thirst following an anaesthetic.
        Furthermore, studies have shown that frozen water is able to quench thirst to a greater
        degree than liquids.
  
        The purpose of this study is to determine whether ice lollies quench post-operative thirst to
        a greater degree than water. Patients are already routinely offered water post-operatively,
        the offering of flavoured ice lollies is a novel intervention for our hospital. We intend to
        investigate two primary outcomes. First, can ice lollies quench post-operative thirst to a
        greater degree than water and therefore improve patient discomfort. Second, if ice lollies
        are found to be superior to water in quenching thirst and improving post-operative
        discomfort, do these patients take less time to recover from their operation?
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The primary outcome measure is the level of post-operative thirst following intervention with either water or ice lolly.
  time frame: Intervention is to be given when the patient is adequately recovered from anaesthesia. An initial thirst score is recorded, then intervention given. Thirst scores are recorded again 15 minutes later to provide data for the primary outcome measure.
  description: Data on pre and post-intervention thirst will be recorded using questionnaires and a numerical rating score from 0 to 10, with 0 being no thirst at all and 10 being very thirsty. These scores will also be sub-divided into no thirst (0), mild thirst (1-3), moderate thirst (4-7) and severe thirst (8-10). This data will undergo statistical analysis to challenge the null hypothesis for the primary outcome measure.
  arm group label: Patients allocated ice lollies to treat post-operative thirst
  arm group type: Experimental
  description: Ice lollies consisted of a flavoured ice popsicle (blackcurrant) provided through hospital catering. Participants were allocated a single ice popsicle with thirst scores recored pre and post intervention.
  arm group label: Patients allocated water as control comparison
  arm group type: Other
  description: Water is a routine treatment for post-operative thirst and therefore used a control to compare our intervention against.
  intervention type: Other
  intervention name: Flavoured ice lollies (popsicles)
  description: Blackcurrant flavoured ice popsicles, 105ml volume.
  arm group label: Patients allocated ice lollies to treat post-operative thirst
  intervention type: Other
  intervention name: Water
  description: Water from tap, one cup given by recovery nurses.
  arm group label: Patients allocated water as control comparison
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: David Sleep, BSc MSc MBBS D.Phil
  role: Principal Investigator
  affiliation: Gloucestershire Hospitals NHS Foundation Trust
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: This is a small centre study with a minor intervention. Participant information is limited to demographic and operative data only.