<?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>IRCT20171113037426N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-13</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Acuprresure on Cesaerian Pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the Effect of Acupressure in LI4 and SP6 Points on Post-Cesarean Section Pain Severity in women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27694</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: A total of 90 women among all women who give birth to cesarean births in Rafsanjan nurseries will be selected in a targeted manner and based on the criteria for entering and leaving the study. Then, they are randomly classified into three groups (two groups of intervention and one control group). So that both groups are consistent with the severity of pain after cesarean section. The first entry in the groups will be random and the rest will be based on the total number of samples in each class. Sampling will continue until the sample size reaches the target. Considering the fact that several factors can affect the pain such as the number of delivery, type of BMSI, age, etc., but ultimately the effect of these factors is measured on the pre-test pain intensity. Therefore, the matching of the three groups based on pre-test pain intensity Is considered, Blinding description: Nine specimens, not individuals who measure pain intensity, will not know how to allocate samples to research groups (intervention or control). And to all the sample, even those in the control group will be told that intervention or touch will reduce pain.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Women undergoing cesarean section.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group 1- Acupuncture at Hugo Point (LI4): These subjects, after being fully conscious while lying back, The researcher will use the thumb of both her hands at the Hugo Point on either side of the mother, for 20 consecutive periods of 10 seconds pressure and 2 seconds of resting. The Hugo point is one of the most important points in the intestinal meridian that located behind the hand between the first and second metacarpal bones and at the base of second metacarpal. The pressure will be deeply and applied the researcher nails are made to change color and the mother feels warm and has mild pain and pressure. Intervention 2: Intervention group:  2- Acupressure at the Saninjao Point (SP6): These subjects, after being fully conscious and returning the sensation of lower limbs while lying back, The researcher will be placed at the bottom of the mother  foot and face-to-face using the thumb of both hands  at the Saninjao Point on either side of the mother will made intervention for 20 consecutive periods of 10 seconds pressure and 2 seconds of resting.  SP6 point is located in the meridian of the spleen, and is located at 4 fingers above the inner ankle behind the posterior margin of the tibia. The pressure will be applied deeply until the researcher nails are made to change color and the mother feels warm and mild pain and pressure. Intervention 3: Control group: After the consciousness and the return of sensation in the lower limbs of these subjects, while lying behind, the researcher will be placed face- to face to them, and in half of them at the Hugo point, and in the other half at the Saninjao point,  will touch on either side of the mother without pressure for 20 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>Marzeyeloripoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rafsanjan Motahari St. Nursing School, Faculty of Nursing and Midwifery</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>marzeyehloripoor@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>teyebeh negahban bonabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rafsanjan Motahari St. Nursing Nursing Faculty, Faculty of Nursing and Midwifery</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34255900</telephone>
        <email>negahban_t@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Term pregnancy 2. No previous experience of acupressure 3. Having ages 45-18 years 4. Lack of a lesion at the site of the practice of pressure or touch 5. No addiction 6. Failure to have speech and hearing ability 7. Not having known psychiatric disorders 8. Not having crises such as divorce, loss of loved ones, immigration or .... over the past 6 months 9. Elective cesarean section   Exit criteria: 1-Unwillingness to cooperate with each of the research units during the study 2. Those with acute complications after cesarean section (severe bleeding, embolism, etc.) 3- Those who during the intervention until the second assessment of the severity of pain will necessarily need to receive the housing</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exit criteria:2. Those with acute complications after cesarean section (severe bleeding, embolism, etc.)3- Those who during the intervention until the second assessment of the severity of pain will necessarily need to receive the housing</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O82.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delivery by emergency caesarean section</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group 1- Acupuncture at Hugo Point (LI4): These subjects, after being fully conscious while lying back, The researcher will use the thumb of both her hands at the Hugo Point on either side of the mother, for 20 consecutive periods of 10 seconds pressure and 2 seconds of resting. The Hugo point is one of the most important points in the intestinal meridian that located behind the hand between the first and second metacarpal bones and at the base of second metacarpal. The pressure will be deeply and applied the researcher nails are made to change color and the mother feels warm and has mild pain and pressure</i_keyword>
      <i_keyword>Intervention group:  2- Acupressure at the Saninjao Point (SP6): These subjects, after being fully conscious and returning the sensation of lower limbs while lying back, The researcher will be placed at the bottom of the mother  foot and face-to-face using the thumb of both hands  at the Saninjao Point on either side of the mother will made intervention for 20 consecutive periods of 10 seconds pressure and 2 seconds of resting.  SP6 point is located in the meridian of the spleen, and is located at 4 fingers above the inner ankle behind the posterior margin of the tibia. The pressure will be applied deeply until the researcher nails are made to change color and the mother feels warm and mild pain and pressure.</i_keyword>
      <i_keyword>Control group: After the consciousness and the return of sensation in the lower limbs of these subjects, while lying behind, the researcher will be placed face- to face to them, and in half of them at the Hugo point, and in the other half at the Saninjao point,  will touch on either side of the mother without pressure for 20 seconds .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post ceaerian section. Timepoint: Immediately and hour after study. Method of measurement: for vas 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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-21</approval_date>
        <contact_name>Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Rafsanjan Imam Ali Boulevard, Central Organization Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
