<?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>IRCT201410278505N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-18</date_registration>
      <primary_sponsor>Vice Chancellor for research of Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on intramuscular  injection pain severity</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure(UB32) on pain severity of intramuscular magnesium sulfate injection(Z technique)in postpartum cesarean section women with severe Precambrian and eclampsia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>47</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8975</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: In current study the first intervention is simple,the second is acupressure in sham control point and the third one is acupressure in UB32 point.Patients are not aware of  which pressure is in real and which is in unreal point.Co-researcher also does not aware of patients injection group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>eclampsia and severe preeclampsia.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention is  intramuscular magnesium sulfate injection with Z technique as a conventional method.5cc of drug will be injected in one buttock and the remaining 5cc will be injected to the other buttock.Then patients will be asked about their pain by co-researcher and according to VAS scale. Intervention 2: The second intervention is intramuscular magnesium sulfate injection with Z technique with acupressure in sham control point which is same in all patients and located in 5cm of posterior superior illiac spine.Acupressure piont is pressed by thumb directly and continuosly with pressure equal to 4.5kg/cm2 for one minute followed by three times sequentially.Then 5cc of drug will be injected in that buttock.Then patients will be asked to lie in the other side and acupressure will be done with same pressure and technique in the other side.Then remaining 5cc will be injected in other buttock immediately.Then patients will be asked about their pain by co-researcher and according to VAS scale. Intervention 3: The third intervention is intramuscular magnesuim sulfate injection with Z technique with acupressure in UB32 point.Acupressure point is pressed by thumb directly and continuously with pressure equal to 4.5kg/cm2 for one minute followed by three times sequentially.Then 5cc of drug will be injected in that buttock immediately.Then patients will be asked to lie in the other side and acupressure will be done with same technique and pressure and the remaining 5cc will be injected to the other buttock.Then patients will be asked about their pain by co-researcher and according to VAS scale.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Setare Nazaribin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3825 2704</telephone>
        <email>setare1991_2013@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Saeed Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Science, Namazi Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098713451978</zip>
        <telephone>+98 71 3647 4255</telephone>
        <email>najafisa@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Range of age between 15-45;Willingness to participate;Gynecologist order for magnesium sulfate injection;No chronic pain in lambosacral area including disk herniation&#13;
&#13;
Exclusion criteria:Unwillingness to participate ; Any psychological disease including depression ;Allergy  to magnesium sulfate;  Receiving  pain killers befor injection(Except diclofenac  suppository);Femur and hip fracture in the last year</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XV,010-016</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>oedema,proteinurea and hypertensive disorder in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention is  intramuscular magnesium sulfate injection with Z technique as a conventional method.5cc of drug will be injected in one buttock and the remaining 5cc will be injected to the other buttock.Then patients will be asked about their pain by co-researcher and according to VAS scale.</i_keyword>
      <i_keyword>The second intervention is intramuscular magnesium sulfate injection with Z technique with acupressure in sham control point which is same in all patients and located in 5cm of posterior superior illiac spine.Acupressure piont is pressed by thumb directly and continuosly with pressure equal to 4.5kg/cm2 for one minute followed by three times sequentially.Then 5cc of drug will be injected in that buttock.Then patients will be asked to lie in the other side and acupressure will be done with same pressure and technique in the other side.Then remaining 5cc will be injected in other buttock immediately.Then patients will be asked about their pain by co-researcher and according to VAS scale.</i_keyword>
      <i_keyword>The third intervention is intramuscular magnesuim sulfate injection with Z technique with acupressure in UB32 point.Acupressure point is pressed by thumb directly and continuously with pressure equal to 4.5kg/cm2 for one minute followed by three times sequentially.Then 5cc of drug will be injected in that buttock immediately.Then patients will be asked to lie in the other side and acupressure will be done with same technique and pressure and the remaining 5cc will be injected to the other buttock.Then patients will be asked about their pain by co-researcher and according to VAS scale</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: immediately after injection. Method of measurement: Visual analoge scale.</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>Vice Chancellor for research of Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-09</approval_date>
        <contact_name>Medical Research Ethics Committee of Shiraz University of Medical sciences</contact_name>
        <contact_address>Central building of Shiraz University of Medical Sciences, Zand street Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
