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/NCT05971134</url>
    </required_header>
    <id_info>
      <org_study_id>Acupressure</org_study_id>
      <nct_id>NCT05971134</nct_id>
    </id_info>
    <brief_title>Acupressure and Fistula Needle Insert Pain Management</brief_title>
    <official_title>The Effect of Acupressure Applied to Different Fistula Area on Fistula Needle Insert Pain: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baskent University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Baskent 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>
        Introduction: This study was conducted to determine the effectiveness of acupressure&#xD;
        application on Hegu (LI4) point on the severity of acute pain caused by fistula needle in&#xD;
        patients with brescia-cimino, snuff-box and antecubital fistula.&#xD;
  &#xD;
        Methods: This study was randomized control study which was conducted with 66 intervention and&#xD;
        65 control participants. The participants in the intervention group were divided into 3&#xD;
        groups according to the fistula area. Data were collected using Descriptive Information Form&#xD;
        and pain scale.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is determined that finger acupuncture at L14 point reduces the severity of pain&#xD;
        felt by the patient during fistula needle insertion. Acute pain during puncture of&#xD;
        arteriovenous fistula is a common problem in hemodialysis patients. Moreover, patients&#xD;
        experience this acute pain three times a week. Accordingly, acupressure applied to the L4&#xD;
        acupuncture point can be considered as an effective, simple and low-cost non-pharmacological&#xD;
        method to reduce acute pain during needle insertion in patients. Since this application is&#xD;
        non-invasive and does not carry the risk of complications, it can be taught to patients&#xD;
        and/or nurses to contribute to the management of acute pain. In addition, in this article, we&#xD;
        examined the effect of acupressure applied only to the LI4 acupuncture point on pain&#xD;
        intensity during fistula needle insertion, therefore, we suggest designing different studies&#xD;
        with different acupuncture points (effective in reducing pain).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">February 1, 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>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric Rating Scale was used to determine the severity of acute pain experienced by patients during fistula needle insertion.</measure>
      <time_frame>1 week</time_frame>
      <description>The pain severity of the patient is determined with the Numeric Rating Scale. NRS includes numbers from 0 to 10. The meaning of the number &quot;0&quot; on the scale is &quot;I have no pain&quot; and the number &quot;10&quot; means &quot;I have very severity pain&quot;.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">131</enrollment>
    <condition>Chronic Kidney Disease Stage 5 (Disorder)</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention group 1 consisted of patients with brescia-cimino fistula Intervention group 2 consisted of patients with snuff-box fistula Intervention group 3 consisted of patients with antecubital fistula.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control group 1 consisted of patients with brescia-cimino fistula Control group 2 consisted of patients with snuff-box fistula Control group 3 consisted of patients with antecubital fistula.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Acupreesure applied</intervention_name>
      <description>Acupressure was applied to the LI4 acupuncture point for 3 minutes by the researcher for the intervention group</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
          18 years or older have brescia-cimino, snuff-box or antecubital fistula speak Turkish have&#xD;
          hemodialysis(HD) treatment three times a week have not used analgesics in the last 6 hours&#xD;
          had no pain who volunteered to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria With aneurysmatic fistula had soft tissue damage infection in&#xD;
          extremities has coagulations and bleeding problems.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Assistant prof. GÜLAY TURGAY</last_name>
      <role>Principal Investigator</role>
      <affiliation>Baskent University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Baskent University</name>
        <address>
          <city>Ankara</city>
          <state>Türkiye</state>
          <zip>109861</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Baskent University</investigator_affiliation>
      <investigator_full_name>Gülay Turgay</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
      <mesh_term>Fistula</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>After the article is published</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/NCT05971134
  org study id: Acupressure
  nct id: NCT05971134
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Introduction: This study was conducted to determine the effectiveness of acupressure
        application on Hegu (LI4) point on the severity of acute pain caused by fistula needle in
        patients with brescia-cimino, snuff-box and antecubital fistula.
  
        Methods: This study was randomized control study which was conducted with 66 intervention and
        65 control participants. The participants in the intervention group were divided into 3
        groups according to the fistula area. Data were collected using Descriptive Information Form
        and pain scale.
  This study is determined that finger acupuncture at L14 point reduces the severity of pain
        felt by the patient during fistula needle insertion. Acute pain during puncture of
        arteriovenous fistula is a common problem in hemodialysis patients. Moreover, patients
        experience this acute pain three times a week. Accordingly, acupressure applied to the L4
        acupuncture point can be considered as an effective, simple and low-cost non-pharmacological
        method to reduce acute pain during needle insertion in patients. Since this application is
        non-invasive and does not carry the risk of complications, it can be taught to patients
        and/or nurses to contribute to the management of acute pain. In addition, in this article, we
        examined the effect of acupressure applied only to the LI4 acupuncture point on pain
        intensity during fistula needle insertion, therefore, we suggest designing different studies
        with different acupuncture points (effective in reducing pain).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  measure: Numeric Rating Scale was used to determine the severity of acute pain experienced by patients during fistula needle insertion.
  time frame: 1 week
  description: The pain severity of the patient is determined with the Numeric Rating Scale. NRS includes numbers from 0 to 10. The meaning of the number "0" on the scale is "I have no pain" and the number "10" means "I have very severity pain".
  arm group label: experimental group
  arm group type: Experimental
  description: Intervention group 1 consisted of patients with brescia-cimino fistula Intervention group 2 consisted of patients with snuff-box fistula Intervention group 3 consisted of patients with antecubital fistula.
  arm group label: Control Group
  arm group type: No Intervention
  description: Control group 1 consisted of patients with brescia-cimino fistula Control group 2 consisted of patients with snuff-box fistula Control group 3 consisted of patients with antecubital fistula.
  intervention type: Behavioral
  intervention name: Acupreesure applied
  description: Acupressure was applied to the LI4 acupuncture point for 3 minutes by the researcher for the intervention group
  arm group label: experimental group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Assistant prof. GÜLAY TURGAY
  role: Principal Investigator
  affiliation: Baskent University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Baskent University
  investigator full name: Gülay Turgay
  investigator title: assistant professor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  mesh term: Fistula
  sharing ipd: No
  ipd description: After the article is published