<?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>IRCT2012123011944N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-07-17</date_registration>
      <primary_sponsor>Vice chancellor for research, Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of  Cupping Therapy and  Acupressure on Postpartum Low Back and Perineal  Pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Cupping Therapy and Acupressure In BL 23 Point on Postpartum Low Back and Perineal Pain (LBPP) in Primiparous Women with Mild to Moderate Anxiety, Referred to Selected Medical-educational Centers of Shiraz University of Medical Sciences, in 2012</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12120</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: low back pain. Condition 2: perineal pain.</hc_freetext>
      <i_freetext>Intervention 1: In the 1st interventional group, cupping therapy is done in at least 4 to 8 hours of childbirth in their postpartum part for every other day and four times a week (15-20 minutes per time); 2 times of interventions were done inpatient and the last outpatient. In this study cupping is done in the mode of dry and hot blazing cotton dipped in alcohol inside the cup and warming it and right after, laying it on the surface of the patient's body. It is possible to apply cupping on BL23 for both low back and perineal pain. Intervention 2: In the 2nd group, researcher symmetrically presses BL23 acupoint on both sides of the backbone, by thumb finger for 5 minutes clockwise and 5 minutes counterclockwise. It lasts 20 minutes per-time. Two times of interventions are done inpatient and the last outpatient. Intervention 3: As control group performance has not been observed by the researcher, she is not allowed to use Acetaminophen. Finally the both types of treatments are presented to the patients through instructional classes or pamphlets.</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>Marzieh Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345-1978</zip>
        <telephone>+98 71 1647 4254</telephone>
        <email>AKBARZADEHMARZIEH@YAHOO.COM</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345- 1978</zip>
        <telephone>+98 71 1647 4254</telephone>
        <email>AKBARZADEHMARZIEH@YAHOO.COM</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Main inclusion criteria to study: 1) 18 - 40 years old; 2) Graduate School at least; 3) Lacking any of overt &amp; Serious psycho-somatic diseases during the study such as: vertebral fractures, herniated disk, acute inflammation, deep vein thrombosis; 4) Mild to moderate anxiety; 5) Residents of Shiraz; 6) Willingness to participate in research and complete consent form; 7) Low back pain only results from lordosis of pregnancy and childbirth deteriorating by fetous weight and position or labour in some mothers. Main exclusion criteria from study: 1) Medical and obstetric complications in the postpartum during the study; 2) Not lookup for following at certain appointments; 3) Asking for exclusion; 4) Using of drugs for pain relief.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
      <hc_code>R10.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>low back pain</hc_keyword>
      <hc_keyword>perineal pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the 1st interventional group, cupping therapy is done in at least 4 to 8 hours of childbirth in their postpartum part for every other day and four times a week (15-20 minutes per time); 2 times of interventions were done inpatient and the last outpatient. In this study cupping is done in the mode of dry and hot blazing cotton dipped in alcohol inside the cup and warming it and right after, laying it on the surface of the patient's body. It is possible to apply cupping on BL23 for both low back and perineal pain.</i_keyword>
      <i_keyword>In the 2nd group, researcher symmetrically presses BL23 acupoint on both sides of the backbone, by thumb finger for 5 minutes clockwise and 5 minutes counterclockwise. It lasts 20 minutes per-time. Two times of interventions are done inpatient and the last outpatient.</i_keyword>
      <i_keyword>As control group performance has not been observed by the researcher, she is not allowed to use Acetaminophen. Finally the both types of treatments are presented to the patients through instructional classes or pamphlets.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Low back pain. Timepoint: 4-8 hours at least after childbirth. Method of measurement: VAS &amp; Mc-Gill pain questionnaires.</prim_outcome>
      <prim_outcome>Perineal pain. Timepoint: 4-8 hours at least after childbirth. Method of measurement: VAS &amp; Mc-Gill pain questionnaires.</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, Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-11-26</approval_date>
        <contact_name>Shiraz University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>7th floor, Central  Building  of Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars Province, Iran, 1978 -71345 Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
