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/NCT06040411</url>
    </required_header>
    <id_info>
      <org_study_id>Mersin University.</org_study_id>
      <nct_id>NCT06040411</nct_id>
    </id_info>
    <brief_title>The Effect of Acupressure on Preoperative Anxiety and Postoperative Pain and Nausea-Vomiting</brief_title>
    <acronym>Acupress</acronym>
    <official_title>The Effect of Acupressure on Preoperative Anxiety and Postoperative Pain and Nausea-Vomiting in ENT Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mersin University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mersin 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>
        The study was conducted in the ENT Clinic of Mersin Şehir Training and Research Hospital&#xD;
        between June 1 and December 1, 2021, with a total of 60 adult patients, 30 in the study group&#xD;
        and 30 in the control group, who met the inclusion and exclusion criteria.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the study, 60 patients were randomly assigned to the study and control groups. The study&#xD;
        group (n = 30) included Shen Men, the 7th acupuncture point (HT7) of the heart meridian&#xD;
        located between the ulna and pisiform bones on the radial side of the flexor carpi ulnaris&#xD;
        tendon, EX-HN3 (Yintang) located in the middle of the beginning of both eyebrows and the&#xD;
        thumb and the LI4 points located in the space between the index finger (between the 1st and&#xD;
        2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial&#xD;
        side) were applied for an average of 15 minutes. No intervention didn't made to the control&#xD;
        group (n = 30). The primary outcome of the study is the effect of acupressure on the state&#xD;
        and trait anxiety level of patients. The secondary outcome of the study is the effect of&#xD;
        acupressure on pain and nausea and vomiting level in patients. Anxiety levels of the patients&#xD;
        were evaluated before and 15 minutes after acupressure application; pain levels were&#xD;
        evaluated at the 4th postoperative hour, before going to bed at night (22.00), waking up in&#xD;
        the morning (08.00) and at discharge; nausea and vomiting levels were evaluated in the first&#xD;
        24 hours after surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2021</start_date>
    <completion_date type="Actual">December 1, 2021</completion_date>
    <primary_completion_date type="Actual">June 1, 2021</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>Prospective, parallel, randomized controlled clinical trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The statistician was blinded to analyze the data.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Anxiety evaluated using the State Anxiety Scale</measure>
      <time_frame>Change from before implementation and immediately after, 15th minutes after implementation</time_frame>
      <description>Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Numerical Pain Scale</measure>
      <time_frame>Change from the 4th hour after surgery, through the discharge, an average of 2 days</time_frame>
      <description>In this scale, the patient is asked to describe the severity of his/her pain in numbers, and the scale consists of a horizontal line, with &quot;0&quot; or &quot;no pain&quot; at the starting point and &quot;10&quot; or &quot;unbearable pain&quot; at the end point. The numbers from 0 to 10 are equally spaced on the horizontal line and 1-3 is defined as mild pain, 4-6 as moderate pain and 7-10 as severe pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nausea and vomiting</measure>
      <time_frame>Change from surgery to the first 24 hours</time_frame>
      <description>The responses for each item are scored between zero (least discomfort) and four (most discomfort). The scores obtained from the eight items are summed to obtain a total score. The maximum score that can be obtained from the index is 32, which is also considered as the most severe symptom occurrence experience score.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Anxiety State</condition>
    <condition>Pain</condition>
    <condition>Vomiting</condition>
    <condition>Nausea</condition>
    <arm_group>
      <arm_group_label>Study Group (experimental)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The order of application was determined by lottery. HT7, LI4 and EX-HN3 points were applied respectively. Before starting the application, the area around to be pressurized was gently rubbed with the palm of the hand for 20-30 seconds. The surrounding tissue was relieved by rubbing gently. After rubbing, pressure was applied to the point determined based on the pain threshold level of each individual with a depth of 1-1.5 cm with the thumb for 5 seconds, rested for 2 seconds and the application was continued for 2 minutes. Acupressure was applied to each point for 2 minutes and the total application time was 15 minutes on average (for 5 points).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard care was given.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Acupressure</intervention_name>
      <description>Acupressure was applied to each point for 2 minutes and the total application time was 15 minutes on average (for 5 points). During the application, the most appropriate position in which the individual would be comfortable was preferred, taking into account the privacy of the individual. First of all, the supine position was preferred, and alternatively, the sitting position was preferred. At the end of the application, it was ensured that the person was in a position that he/she was comfortable.</description>
      <arm_group_label>Study Group (experimental)</arm_group_label>
      <other_name>Acupress</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Emergency ENT surgery,&#xD;
  &#xD;
            -  Refused to participate in the research,&#xD;
  &#xD;
            -  Did not sign the Informed Consent Form,&#xD;
  &#xD;
            -  Have a physical problem that prevents the application of acupressure to EX-HN3&#xD;
               (Yintang), LI4 and HT7 points,&#xD;
  &#xD;
            -  Diagnosed with anxiety, panic attacks and taking medication for anxiety,&#xD;
  &#xD;
            -  Previous surgical experience,&#xD;
  &#xD;
            -  Under 18 and over 65,&#xD;
  &#xD;
            -  People with vision, hearing and perception problems,&#xD;
  &#xD;
            -  unable to read and write Turkish,&#xD;
  &#xD;
            -  Have any problem that prevents them from communicating cognitively, emotionally and&#xD;
               verbally,&#xD;
  &#xD;
            -  Experience in acupressure,&#xD;
  &#xD;
            -  Patients who have received sedative medication before surgical intervention didn't be&#xD;
               included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Emergency ENT surgery,&#xD;
  &#xD;
            -  Refused to participate in the research,&#xD;
  &#xD;
            -  Did not sign the Informed Consent Form,&#xD;
  &#xD;
            -  Diagnosed with anxiety, panic attacks and taking medication for anxiety,&#xD;
  &#xD;
            -  Previous surgical experience&#xD;
  &#xD;
            -  Under 18 and over 65,&#xD;
  &#xD;
            -  People with vision, hearing and perception problems,&#xD;
  &#xD;
            -  unable to read and write Turkish,&#xD;
  &#xD;
            -  Have any problem that prevents them from communicating cognitively, emotionally and&#xD;
               verbally,&#xD;
  &#xD;
            -  Experience in acupressure,&#xD;
  &#xD;
            -  Patients who have received sedative medication before surgical intervention didn't be&#xD;
               included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gülay ALTUN UĞRAŞ, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Mersin University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Serpil YÜKSEL, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Necmettin Erbakan University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Bahar TAŞDELEN, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mersin University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Seda TÜRKİLİ, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mersin City Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Serkan TÜRKİLİ, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mersin City Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmet KARAMAN, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mersin University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tuğba ÇAM YANIK</name>
        <address>
          <city>Yeni̇şehi̇r</city>
          <state>Mersin</state>
          <zip>33120</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mersin University</investigator_affiliation>
      <investigator_full_name>Tugba CAM YANIK</investigator_full_name>
      <investigator_title>Principal Investigator Research Assistant</investigator_title>
    </responsible_party>
    <keyword>pain</keyword>
    <keyword>ENT patients</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Nausea</mesh_term>
      <mesh_term>Vomiting</mesh_term>
      <mesh_term>Anxiety Disorders</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/NCT06040411
  org study id: Mersin University.
  nct id: NCT06040411
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study was conducted in the ENT Clinic of Mersin Şehir Training and Research Hospital
        between June 1 and December 1, 2021, with a total of 60 adult patients, 30 in the study group
        and 30 in the control group, who met the inclusion and exclusion criteria.
  In the study, 60 patients were randomly assigned to the study and control groups. The study
        group (n = 30) included Shen Men, the 7th acupuncture point (HT7) of the heart meridian
        located between the ulna and pisiform bones on the radial side of the flexor carpi ulnaris
        tendon, EX-HN3 (Yintang) located in the middle of the beginning of both eyebrows and the
        thumb and the LI4 points located in the space between the index finger (between the 1st and
        2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial
        side) were applied for an average of 15 minutes. No intervention didn't made to the control
        group (n = 30). The primary outcome of the study is the effect of acupressure on the state
        and trait anxiety level of patients. The secondary outcome of the study is the effect of
        acupressure on pain and nausea and vomiting level in patients. Anxiety levels of the patients
        were evaluated before and 15 minutes after acupressure application; pain levels were
        evaluated at the 4th postoperative hour, before going to bed at night (22.00), waking up in
        the morning (08.00) and at discharge; nausea and vomiting levels were evaluated in the first
        24 hours after surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, parallel, randomized controlled clinical trial
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  masking description: The statistician was blinded to analyze the data.
  measure: Anxiety evaluated using the State Anxiety Scale
  time frame: Change from before implementation and immediately after, 15th minutes after implementation
  description: Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high
  measure: Numerical Pain Scale
  time frame: Change from the 4th hour after surgery, through the discharge, an average of 2 days
  description: In this scale, the patient is asked to describe the severity of his/her pain in numbers, and the scale consists of a horizontal line, with "0" or "no pain" at the starting point and "10" or "unbearable pain" at the end point. The numbers from 0 to 10 are equally spaced on the horizontal line and 1-3 is defined as mild pain, 4-6 as moderate pain and 7-10 as severe pain.
  measure: Nausea and vomiting
  time frame: Change from surgery to the first 24 hours
  description: The responses for each item are scored between zero (least discomfort) and four (most discomfort). The scores obtained from the eight items are summed to obtain a total score. The maximum score that can be obtained from the index is 32, which is also considered as the most severe symptom occurrence experience score.
  arm group label: Study Group (experimental)
  arm group type: Experimental
  description: The order of application was determined by lottery. HT7, LI4 and EX-HN3 points were applied respectively. Before starting the application, the area around to be pressurized was gently rubbed with the palm of the hand for 20-30 seconds. The surrounding tissue was relieved by rubbing gently. After rubbing, pressure was applied to the point determined based on the pain threshold level of each individual with a depth of 1-1.5 cm with the thumb for 5 seconds, rested for 2 seconds and the application was continued for 2 minutes. Acupressure was applied to each point for 2 minutes and the total application time was 15 minutes on average (for 5 points).
  arm group label: Standard of care
  arm group type: No Intervention
  description: Standard care was given.
  intervention type: Other
  intervention name: Acupressure
  description: Acupressure was applied to each point for 2 minutes and the total application time was 15 minutes on average (for 5 points). During the application, the most appropriate position in which the individual would be comfortable was preferred, taking into account the privacy of the individual. First of all, the supine position was preferred, and alternatively, the sitting position was preferred. At the end of the application, it was ensured that the person was in a position that he/she was comfortable.
  arm group label: Study Group (experimental)
  other name: Acupress
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gülay ALTUN UĞRAŞ, PhD
  role: Study Director
  affiliation: Mersin University
  last name: Serpil YÜKSEL, PhD
  role: Principal Investigator
  affiliation: Necmettin Erbakan University
  last name: Bahar TAŞDELEN, PhD
  role: Principal Investigator
  affiliation: Mersin University
  last name: Seda TÜRKİLİ, Doctor
  role: Principal Investigator
  affiliation: Mersin City Hospital
  last name: Serkan TÜRKİLİ, Doctor
  role: Principal Investigator
  affiliation: Mersin City Hospital
  last name: Ahmet KARAMAN, PhD
  role: Principal Investigator
  affiliation: Mersin University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Mersin University
  investigator full name: Tugba CAM YANIK
  investigator title: Principal Investigator Research Assistant
  mesh term: Pain, Postoperative
  mesh term: Nausea
  mesh term: Vomiting
  mesh term: Anxiety Disorders
  sharing ipd: No