<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/NCT02213185</url>
  </required_header>
  <id_info>
    <org_study_id>O-9-2013</org_study_id>
    <nct_id>NCT02213185</nct_id>
  </id_info>
  <brief_title>EMLA and Sterile Water Injections - Pain From Injections</brief_title>
  <official_title>Effect of EMLA® Patches for Reducing Pain Associated With Sterile Water Injections - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Skövde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Skövde</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile&#xD;
      water injections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sterile Water Injection (SWI) was previously shown to give good pain relief for lower-back&#xD;
      pain during childbirth, chronic neck pain and ureterolithiasis. However, the pain associated&#xD;
      with the injections remains problematic, and therefore it is important to find a less painful&#xD;
      injection technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">December 18, 2019</completion_date>
  <primary_completion_date type="Actual">December 18, 2019</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self reported experience of injection pain measured by Visual Analogue Scale following Sterile Water Injections</measure>
    <time_frame>15 minutes</time_frame>
    <description>Self reported experiences of pain with Visual Analogue Scale 0=no pain 10=worst imaginable pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self reported (questionnaire descriptive via email), self-reported experiences of side effects following Sterile Water injections</measure>
    <time_frame>24 hours</time_frame>
    <description>Self reported (questionnaire descriptive via email), self-reported experiences of of side effects following Sterile Water injections</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>EMLA patches and SWI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EMLA patches 1.5 hrs before sterile water injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EMLA patches and isotonic saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EMLA patches 1.5 hrs before isotonic saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo patches and SWI</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>PLACEBO patches 1.5 hrs before sterile water injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo patches and isotonic saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>PLACEBO patches 1.5 hrs before isotonic saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EMLA patches</intervention_name>
    <description>EMLA patches 1.5 hrs before sterile water injections</description>
    <arm_group_label>EMLA patches and SWI</arm_group_label>
    <arm_group_label>EMLA patches and isotonic saline</arm_group_label>
    <arm_group_label>Placebo patches and SWI</arm_group_label>
    <arm_group_label>Placebo patches and isotonic saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Woman&#xD;
&#xD;
          -  Age 18-45 years&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Ability to understand information and instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous experience of SWI&#xD;
&#xD;
          -  On-going pain&#xD;
&#xD;
          -  Use of medication for depression, pain, or sleeping disorder 24 hours prior to the&#xD;
             experiment&#xD;
&#xD;
          -  Smoking, snuffing, physical activity, and intake of caffeinated beverages (coffee,&#xD;
             tea, or energy drink (e.g., Red Bull) 2 hours prior to the experiment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lena B Mårtensson, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Skövde</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Health Sciences, University of Skövde</name>
      <address>
        <city>Skövde</city>
        <zip>SE-541 28</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>January 18, 2020</last_update_submitted>
  <last_update_submitted_qc>January 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Skövde</investigator_affiliation>
    <investigator_full_name>Lena B Martensson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Sterile water injections</keyword>
  <keyword>Pain</keyword>
  <keyword>VAS</keyword>
  <keyword>Complementary method</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02213185
org study id: O-9-2013
nct id: NCT02213185
lead sponsor: 
has dmc: No
The aim is to study the effect of local anaesthesia (EMLA®) on pain associated with sterile
      water injections.
Sterile Water Injection (SWI) was previously shown to give good pain relief for lower-back
      pain during childbirth, chronic neck pain and ureterolithiasis. However, the pain associated
      with the injections remains problematic, and therefore it is important to find a less painful
      injection technique.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Self reported experience of injection pain measured by Visual Analogue Scale following Sterile Water Injections
time frame: 15 minutes
description: Self reported experiences of pain with Visual Analogue Scale 0=no pain 10=worst imaginable pain
measure: Self reported (questionnaire descriptive via email), self-reported experiences of side effects following Sterile Water injections
time frame: 24 hours
description: Self reported (questionnaire descriptive via email), self-reported experiences of of side effects following Sterile Water injections
arm group label: EMLA patches and SWI
arm group type: Experimental
description: EMLA patches 1.5 hrs before sterile water injections
arm group label: EMLA patches and isotonic saline
arm group type: Active Comparator
description: EMLA patches 1.5 hrs before isotonic saline
arm group label: Placebo patches and SWI
arm group type: Placebo Comparator
description: PLACEBO patches 1.5 hrs before sterile water injections
arm group label: Placebo patches and isotonic saline
arm group type: Placebo Comparator
description: PLACEBO patches 1.5 hrs before isotonic saline
intervention type: Other
intervention name: EMLA patches
description: EMLA patches 1.5 hrs before sterile water injections
arm group label: EMLA patches and SWI
arm group label: EMLA patches and isotonic saline
arm group label: Placebo patches and SWI
arm group label: Placebo patches and isotonic saline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lena B Mårtensson, Professor
role: Principal Investigator
affiliation: University of Skövde
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: University of Skövde
investigator full name: Lena B Martensson
investigator title: Professor
mesh term: Infertility
sharing ipd: Undecided