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/NCT06035237</url>
    </required_header>
    <id_info>
      <org_study_id>Özkan</org_study_id>
      <nct_id>NCT06035237</nct_id>
    </id_info>
    <brief_title>The Effect of Cold Spray Applied Before Local Anaesthesia</brief_title>
    <acronym>EffectofCold</acronym>
    <official_title>The Effect of Cold Spray Applied Before Local Anaesthesia on Pain and Anxiety in Coronary Angiography Procedure: A Randomised Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ozkan Sir</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yuzuncu Yıl 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>
        Coronary angiography is a reliable and valid method used in the diagnosis of Coronary Artery&#xD;
        Disease (CAD). Coronary angiography is defined as the process of obtaining cineangiographic&#xD;
        images by administering radio-opaque material to the coronary vessels via arterial route.&#xD;
        Coronary angiography is frequently performed from brachial, radial and femoral arteries. The&#xD;
        aim of coronary angiography is to determine the presence, localisation and extent of&#xD;
        cardiovascular lesions.&#xD;
  &#xD;
        Invasive interventions cause anxiety and pain in the patient, increase the level of anxiety&#xD;
        and cause a number of negative effects such as increased use of sedative drugs, development&#xD;
        of post-procedure complications, prolongation of the recovery process and hospitalisation&#xD;
        time. It is stated that there is a positive relationship between reducing the anxiety of the&#xD;
        patients and meeting the needs of the patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 3, 2023</start_date>
    <completion_date type="Anticipated">December 6, 2024</completion_date>
    <primary_completion_date type="Actual">March 5, 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, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain levels recorded with the Visual Analog Scale</measure>
      <time_frame>1 minute</time_frame>
      <description>VAS was used to evaluate the pain of the patients. The scale consists of emotion adjectives in which each emotion experienced by the person at that moment is marked with a vertical line on a plane. A value of zero is considered as not experiencing pain at all, and a value of ten is considered as experiencing pain completely.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Pain</condition>
    <condition>Anxiety</condition>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in the experimental group were informed that cold spray would be applied to their arm in a supine position to reduce procedure-related pain. For femoral artery angiography, the central part of the inguinal access area was targeted, and for radial angiography, 2 cm above the styloid process of the radial bone was targeted, and cold spray (Chloroethyl spray) was applied for approximately 3 seconds from a height of 10 cm.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Pain levels recorded with the VAS were evaluated for patients after the procedure using the state anxiety scale. Pain levels for control group patients were also assessed and recorded within the sheath after intravenous solutions were given. Anxiety levels were recorded after the procedure was completed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cold Spray</intervention_name>
      <description>Cold Spray: Cold sprays, composed of liquefied gases under high pressure, rapidly evaporate from the applied area, causing a sudden drop in skin temperature. This condition leads to the temporary desensitization of pain receptors or the activation of ion channels, resulting in the brief alleviation of pain sensation. Various medical, non-medical, and surgical methods are employed to manage pain. Cold sprays are among non-medical methods, including massage, cold application, and distraction techniques. Therefore, cold sprays cannot be prescribed like medication. They are used for local anesthesia in cases of acute trauma, injections, blood collection, vein puncture, and similar situations.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being between the ages of 18 and above.&#xD;
  &#xD;
            -  Not having used any anesthetic substance before the procedure.&#xD;
  &#xD;
            -  Not having undergone angiography before.&#xD;
  &#xD;
            -  Having no communication problems.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having previously undergone angiography.&#xD;
  &#xD;
            -  Having taken analgesics before angiography.&#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_contact>
      <last_name>Özkan SİR, PhD</last_name>
      <phone>+905459072231</phone>
      <email>ozkansir@yyu.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Van yüzüncü yıl university</name>
        <address>
          <city>Van</city>
          <zip>65080</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Özkan SİR</last_name>
        <email>ozkansir@yyu.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 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>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
      <investigator_full_name>Ozkan Sir</investigator_full_name>
      <investigator_title>PhD student</investigator_title>
    </responsible_party>
    <keyword>Pain, anxiety, cold spray, angiography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Anxiety Disorders</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/NCT06035237
  org study id: Özkan
  nct id: NCT06035237
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Coronary angiography is a reliable and valid method used in the diagnosis of Coronary Artery
        Disease (CAD). Coronary angiography is defined as the process of obtaining cineangiographic
        images by administering radio-opaque material to the coronary vessels via arterial route.
        Coronary angiography is frequently performed from brachial, radial and femoral arteries. The
        aim of coronary angiography is to determine the presence, localisation and extent of
        cardiovascular lesions.
  
        Invasive interventions cause anxiety and pain in the patient, increase the level of anxiety
        and cause a number of negative effects such as increased use of sedative drugs, development
        of post-procedure complications, prolongation of the recovery process and hospitalisation
        time. It is stated that there is a positive relationship between reducing the anxiety of the
        patients and meeting the needs of the patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Care Provider)
  measure: Pain levels recorded with the Visual Analog Scale
  time frame: 1 minute
  description: VAS was used to evaluate the pain of the patients. The scale consists of emotion adjectives in which each emotion experienced by the person at that moment is marked with a vertical line on a plane. A value of zero is considered as not experiencing pain at all, and a value of ten is considered as experiencing pain completely.
  arm group label: Experimental Group
  arm group type: Experimental
  description: Patients in the experimental group were informed that cold spray would be applied to their arm in a supine position to reduce procedure-related pain. For femoral artery angiography, the central part of the inguinal access area was targeted, and for radial angiography, 2 cm above the styloid process of the radial bone was targeted, and cold spray (Chloroethyl spray) was applied for approximately 3 seconds from a height of 10 cm.
  arm group label: Control Group
  arm group type: No Intervention
  description: Pain levels recorded with the VAS were evaluated for patients after the procedure using the state anxiety scale. Pain levels for control group patients were also assessed and recorded within the sheath after intravenous solutions were given. Anxiety levels were recorded after the procedure was completed.
  intervention type: Other
  intervention name: Cold Spray
  description: Cold Spray: Cold sprays, composed of liquefied gases under high pressure, rapidly evaporate from the applied area, causing a sudden drop in skin temperature. This condition leads to the temporary desensitization of pain receptors or the activation of ion channels, resulting in the brief alleviation of pain sensation. Various medical, non-medical, and surgical methods are employed to manage pain. Cold sprays are among non-medical methods, including massage, cold application, and distraction techniques. Therefore, cold sprays cannot be prescribed like medication. They are used for local anesthesia in cases of acute trauma, injections, blood collection, vein puncture, and similar situations.
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Özkan SİR, PhD
  phone: +905459072231
  email: ozkansir@yyu.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Yuzuncu Yıl University
  investigator full name: Ozkan Sir
  investigator title: PhD student
  mesh term: Coronary Artery Disease
  mesh term: Anxiety Disorders