<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20171231038155N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-29</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Influence Of Pressure And Rapid Release Of Muscle On The Pain Caused By Muscle Intramuscular Injection</public_title>
      <acronym></acronym>
      <scientific_title>Comparison Of The Effects Of Skin Pulling, Pressure And Quick Release Of Muscle By Conventional Method On Pain Induced By Intramuscular Injection.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28589</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Considering That This Study Examines The Effect Of Skin Pulling, The Pressure And Quick Release Of Muscle On The Pain Caused By Muscle Injections, This Method Is The First One To Be Done, And It May Be Hard To Understand How This Method Is For The Readers. A Brief Video Of How To Inject Should Be Attached To The Article, Blinding description: In This Study, All Injections Were Performed By A Qualified Nurse. Participants Were Unaware Of The Injection Method And After Injection, The Pain Assessment Was Done By Another Nurse Who Was Also Unaware Of The Injection Method. Finally, The Statistical Analyst Did Not Know How To Inject, So That Injections A And B Were Delivered To The Statistician.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain Caused By Muscle Transfusion.</hc_freetext>
      <i_freetext>Intervention Group: Injection By Inventive Method (Pulling Skin, Pressure And Rapid Release Of Muscle) After Dragging And Applying Deep Pressure With The Needle Entry At 90 °, The Muscle Quickly Released And Injection After Aspiration At 1 Cc In 10 Seconds To Be In This Method, The Actual Release Of The Muscle Causes The Needle To Enter, And The Needle Movement Is Inactive By The Dominant Hand And The Main Role Is To Remove The Pressure From The Muscle By The Non-Dominant Hand. All Injections Were Performed Using A 5-cc Syringe With A Needle Number 22Mm, And The Air Locking Technique Was Performed With Two 0.2cc In All Injections. The Use Of Alcohol-Impregnated Cotton Was Used To Sterilize Injection Site. Meanwhile, A Gap Was Not Considered Between The Two Injections Except The Completion Of The Pain Assessment Questionnaire.                                                                                Control Group: In The Conventional Injection Method, The Pressure Was Not Applied And After Pulling The Skin Between The Fingers And The Needle Pointed In A Dart Manner With A 90 Degree Angle Entered And After Aspiration, Injected At 1Cc In 10 Seconds.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>maryam  salary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abu Mosalm Street - Abu Mosalm 8 -Plat 14</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9619614479</zip>
        <telephone>+98 51 4464 8905</telephone>
        <email>elham.salary77@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>maryam salary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abu Mosalm Street - Abu Mosalm 8 -Plat 14</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9619614479</zip>
        <telephone>+98 51 4464 8905</telephone>
        <email>elham.salary77@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The Criteria For Entering The Research Include Ages 16 To 60
The Lack Of Communication Problems Such As Hearing, Visual, Speech And Common Language
The Same Volume In The Patient's Dorsogluteal Muscle
Having Written Consent</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having Scar, Redness, Bruising, Sensitivity And Stiffness At The Injection Site, Neuropathy
Having A History Of Injections In The Last Two Weeks
Severe Pain Caused By The Disease
Severe Fear Of Injection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Injection By Inventive Method (Pulling Skin, Pressure And Rapid Release Of Muscle) After Dragging And Applying Deep Pressure With The Needle Entry At 90 °, The Muscle Quickly Released And Injection After Aspiration At 1 Cc In 10 Seconds To Be In This Method, The Actual Release Of The Muscle Causes The Needle To Enter, And The Needle Movement Is Inactive By The Dominant Hand And The Main Role Is To Remove The Pressure From The Muscle By The Non-Dominant Hand. All Injections Were Performed Using A 5-cc Syringe With A Needle Number 22Mm, And The Air Locking Technique Was Performed With Two 0.2cc In All Injections. The Use Of Alcohol-Impregnated Cotton Was Used To Sterilize Injection Site. Meanwhile, A Gap Was Not Considered Between The Two Injections Except The Completion Of The Pain Assessment Questionnaire.                                                                                Control Group: In The Conventional Injection Method, The Pressure Was Not Applied And After Pulling The Skin Between The Fingers And The Needle Pointed In A Dart Manner With A 90 Degree Angle Entered And After Aspiration, Injected At 1Cc In 10 Seconds</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: In This Study, The Pain After Each Injection Is Evaluated Using VAS, So That Each Patient Is Dosed Twice And Immediately After Each Injection, And The Distance Between The Two Injections In Each Patient Is Just As Much As The Pain Questionnaire. Method of measurement: VAS.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-11</approval_date>
        <contact_name>Ethics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Abu Mosalm Street -Abu Moslem 8th , No. 14 Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
