<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/NCT04420559</url>
  </required_header>
  <id_info>
    <org_study_id>18/18</org_study_id>
    <nct_id>NCT04420559</nct_id>
  </id_info>
  <brief_title>Intramuscular Benzathine Penicillin Injection Procedure</brief_title>
  <official_title>The Use of Virtual Reality and Distraction Cards to Reduce Pain During Intramuscular Benzathine Penicillin Injection Procedure in Adults: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi</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 aim of this study was the determination of the effect of applying VR and DC distraction&#xD;
      methods on patients' pain and satisfaction levels during IM benzathine penicillin injection.&#xD;
&#xD;
      The research hypothesis:&#xD;
&#xD;
        1. Are Virtual Reality and Distraction Card effective in reducing pain due to injection of&#xD;
           IM benzathine penicillin?&#xD;
&#xD;
        2. Does the use of Virtual Reality and Distraction Card during the injection process of IM&#xD;
           benzathine penicillin have an effect on patient satisfaction?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2018</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale for pain measurement</measure>
    <time_frame>4 months</time_frame>
    <description>(Minimum score: 0 ; Maximum score:10) Higher scores mean a worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale for satisfaction measurement (Minimum score: 0 ; Maximum score:10)</measure>
    <time_frame>4 months</time_frame>
    <description>(Minimum score: 0 ; Maximum score:10) Higher scores mean a better outcome</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Injection Site Discomfort</condition>
  <arm_group>
    <arm_group_label>Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Distraction Card</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intramuscular Injection</intervention_name>
    <description>Intramuscular Benzathine Penicillin Injection Procedure</description>
    <arm_group_label>Distraction Card</arm_group_label>
    <arm_group_label>Virtual Reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  agree to participate in the research,&#xD;
&#xD;
          -  being over the age of 18,&#xD;
&#xD;
          -  being native speaker,&#xD;
&#xD;
          -  not having vision and hearing problems,&#xD;
&#xD;
          -  being prescribed benzathine penicillin with a dose of 1.200.000 IU,&#xD;
&#xD;
          -  being experienced of IM injection,&#xD;
&#xD;
          -  not having IM injection for the last 1 month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  volunteers who have scar, incision, lipodystrophy, abscess, necrosis, hematoma,&#xD;
             ecchymosis, infection, pain and paralysis at the VG site&#xD;
&#xD;
          -  volunteers are excluded if the injection process cannot be performed at one time&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tulay Basak</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saglik Bilimleri Universitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gulhane Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
    <investigator_full_name>Tulay Basak</investigator_full_name>
    <investigator_title>Head of Fundamentals of Nursing Department</investigator_title>
  </responsible_party>
  <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/NCT04420559
org study id: 18/18
nct id: NCT04420559
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was the determination of the effect of applying VR and DC distraction
      methods on patients' pain and satisfaction levels during IM benzathine penicillin injection.

      The research hypothesis:

        1. Are Virtual Reality and Distraction Card effective in reducing pain due to injection of
           IM benzathine penicillin?

        2. Does the use of Virtual Reality and Distraction Card during the injection process of IM
           benzathine penicillin have an effect on patient satisfaction?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Visual Analog Scale for pain measurement
time frame: 4 months
description: (Minimum score: 0 ; Maximum score:10) Higher scores mean a worse outcome
measure: Visual Analog Scale for satisfaction measurement (Minimum score: 0 ; Maximum score:10)
time frame: 4 months
description: (Minimum score: 0 ; Maximum score:10) Higher scores mean a better outcome
arm group label: Virtual Reality
arm group type: Experimental
arm group label: Distraction Card
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: Intramuscular Injection
description: Intramuscular Benzathine Penicillin Injection Procedure
arm group label: Distraction Card
arm group label: Virtual Reality
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tulay Basak
role: Principal Investigator
affiliation: Saglik Bilimleri Universitesi
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi
investigator full name: Tulay Basak
investigator title: Head of Fundamentals of Nursing Department
sharing ipd: No