<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/NCT04421599</url>
  </required_header>
  <id_info>
    <org_study_id>0000-0001-7881-8556</org_study_id>
    <nct_id>NCT04421599</nct_id>
  </id_info>
  <brief_title>Necessity of Aspiration in the Ventrogluteal Site</brief_title>
  <official_title>Investigation of the Necessity of Aspiration During The Intramuscular Injection Administered in the Ventrogluteal Site and Its Effect on Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      H1: Aspiration is not necessary for IM injections applied from the ventrogluteal region.&#xD;
&#xD;
      H2: Aspiration procedure increases pain in IM injections applied from ventrogluteal region.&#xD;
&#xD;
      H3: The duration of the aspiration procedure on IM injections applied from the ventrogluteal&#xD;
      region is effective on pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Anticipated">June 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 10, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Individual Introductory Information Form</measure>
    <time_frame>15 minutes</time_frame>
    <description>The content of the study was explained to the patients coming to the emergency room. Written informed consents were obtained in line with the &quot;Individual Introductory Information Form&quot; of the patients.&#xD;
Individual Introductory Information Form: This form includes questions such as the patient's application group, diagnosis, age, gender, height, weight, and blood intake during aspiration in intramuscular injection. It is completed within the first 10-15 minutes of contact with the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Intramuscular injection was performed in accordance with the application group assigned to the patients who filled the Individual Introductory Information Form. The patients were not told which group they belonged to.&#xD;
A nurse who except the researcher who performed the application evaluated pain levels that patients feel during injection immediately after the intramuscular injection application, with a Visual Analog Scale. The minimum score that can be obtained from this scale is 0 and the maximum score is 10. A higher score indicates that the pain is more severe. This scale was applied in minutes 1-5 after intramuscular injection.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">834</enrollment>
  <condition>Nursing</condition>
  <condition>Injection Site</condition>
  <arm_group>
    <arm_group_label>Experimental Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Group A who were administered intramuscular injection during which aspiration lasted for 5-10 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group who were administered intramuscular injection during which aspiration lasted for 1-2 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Group B who were not administered aspiration during IM injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The Necessity of Aspiration</intervention_name>
    <description>The patients who met the inclusion criteria and agreed to participate in the study were assigned to the Experimental Group A who were administered IM injection during which aspiration lasted for 5-10 seconds, to the Control Group who were administered IM injection during which aspiration lasted for 1-2 seconds, and to the Experimental Group B who were not administered IM injection according to the stratified block randomization list. The same &quot;Intramuscular Injection Application Protocol&quot; was applied while all the injections were administered.</description>
    <arm_group_label>Experimental Group A</arm_group_label>
    <arm_group_label>Experimental Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who came to the Emergency Service Care Unit for &quot;Diclofenac Sodium&quot; injection&#xD;
&#xD;
          -  Have no vision and hearing problems,&#xD;
&#xD;
          -  Who have no disease that may affect their perception of pain&#xD;
&#xD;
          -  Who can evaluate the &quot;Visual Analog Scale&quot; correctly, scoring 5 points or less from&#xD;
             the VAS,&#xD;
&#xD;
          -  Body Mass Index is between 18.5-24.9 kg / m2,&#xD;
&#xD;
          -  Who do not have any discomfort in the extremities that will prevent them from taking&#xD;
             the desired position,&#xD;
&#xD;
          -  No complications due to intramuscular injections such as abscess, infection, tissue&#xD;
             necrosis and hematoma in the ventrogluteal region&#xD;
&#xD;
          -  No nodules or masses in the area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse the injection are excluded.&#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>
  <location>
    <facility>
      <name>Ege University Hospital</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Beyea SC, Nicoll LH. Administration of medications via the intramuscular route: an integrative review of the literature and research-based protocol for the procedure. Appl Nurs Res. 1995 Feb;8(1):23-33. doi: 10.1016/s0897-1897(95)80279-7.</citation>
    <PMID>7695353</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Leyla BARAN</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Ventrogluteal area</keyword>
  <keyword>aspiration</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04421599
org study id: 0000-0001-7881-8556
nct id: NCT04421599
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
H1: Aspiration is not necessary for IM injections applied from the ventrogluteal region.

      H2: Aspiration procedure increases pain in IM injections applied from ventrogluteal region.

      H3: The duration of the aspiration procedure on IM injections applied from the ventrogluteal
      region is effective on pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Individual Introductory Information Form
time frame: 15 minutes
description: The content of the study was explained to the patients coming to the emergency room. Written informed consents were obtained in line with the "Individual Introductory Information Form" of the patients.
Individual Introductory Information Form: This form includes questions such as the patient's application group, diagnosis, age, gender, height, weight, and blood intake during aspiration in intramuscular injection. It is completed within the first 10-15 minutes of contact with the patient.
measure: Visual Analog Scale (VAS)
time frame: 5 minutes
description: Intramuscular injection was performed in accordance with the application group assigned to the patients who filled the Individual Introductory Information Form. The patients were not told which group they belonged to.
A nurse who except the researcher who performed the application evaluated pain levels that patients feel during injection immediately after the intramuscular injection application, with a Visual Analog Scale. The minimum score that can be obtained from this scale is 0 and the maximum score is 10. A higher score indicates that the pain is more severe. This scale was applied in minutes 1-5 after intramuscular injection.
arm group label: Experimental Group A
arm group type: Experimental
description: Experimental Group A who were administered intramuscular injection during which aspiration lasted for 5-10 seconds.
arm group label: Control Group
arm group type: No Intervention
description: Control Group who were administered intramuscular injection during which aspiration lasted for 1-2 seconds.
arm group label: Experimental Group B
arm group type: Experimental
description: Experimental Group B who were not administered aspiration during IM injection.
intervention type: Other
intervention name: The Necessity of Aspiration
description: The patients who met the inclusion criteria and agreed to participate in the study were assigned to the Experimental Group A who were administered IM injection during which aspiration lasted for 5-10 seconds, to the Control Group who were administered IM injection during which aspiration lasted for 1-2 seconds, and to the Experimental Group B who were not administered IM injection according to the stratified block randomization list. The same "Intramuscular Injection Application Protocol" was applied while all the injections were administered.
arm group label: Experimental Group A
arm group label: Experimental Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
citation: Beyea SC, Nicoll LH. Administration of medications via the intramuscular route: an integrative review of the literature and research-based protocol for the procedure. Appl Nurs Res. 1995 Feb;8(1):23-33. doi: 10.1016/s0897-1897(95)80279-7.
PMID: 7695353
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Leyla BARAN
investigator title: Dr.
sharing ipd: No