<?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>IRCT20220910055926N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-13</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The comparison of effectiveness of acupressure six spleen and Hugo point on the severity of postpartum pain</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of effectiveness of acupressure six spleen and Hugo point on the severity of postpartum pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65810</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method using 6 blocks will be used. A third person who is not involved in the process of diagnosing and evaluating patients will create a random sequence using the site: https://www.sealedenvelope.com and based on the sample size, 12 blocks of 6 will be created. Each patient will be given a unique code that can be created on this site, Blinding description: In this research, in order to prevent bias of the interventionist, data collection is done by another person who does not perform the intervention, who does not know about the allocation of the participants in the research groups. In the current study, there is no possibility of blinding the researcher because he is aware of the acupressure points and the stimulation of the points is done by him, but since the participants do not have previous experience of acupressure and do not know where the two desired points are located, the study is a Sue is blind. Also, the information analyst does not know about the allocation of groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Severity of labor pain.</hc_freetext>
      <i_freetext>Intervention 1: Spleen point 6 acupressure: Acupressure intervention at spleen point 6 and intervention at Hugo point are applied bilaterally, in periods of 10 seconds of pressure and 2 seconds of rest for 20 minutes consecutively. The amount of applied pressure is such that the samples feel warm and have slight pain and pressure. Spleen pressure point 6 is in the Spleen meridian and is located 5 cm above the inner angle of the tibia, and the location of the Hugo point is anatomically in the back of the hand between the first and second metacarpal bones and almost along the radial bone. Intervention 2: Hugo point acupressure:  Acupressure intervention at spleen point 6 and intervention at Hugo point are applied bilaterally, in periods of 10 seconds of pressure and 2 seconds of rest for 20 minutes consecutively. The amount of applied pressure is such that the samples feel warm and have slight pain and pressure. Spleen pressure point 6 is in the Spleen meridian and is located 5 cm above the inner angle of the tibia, and the location of the Hugo point is anatomically in the back of the hand between the first and second metacarpal bones and almost along the radial bone.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saba Mohamad Ghasem Nezhad Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah, Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۵۶۱۶۴۹۸۳۱</zip>
        <telephone>+98 83 3828 2101</telephone>
        <email>sabamgm1992@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saba Mohamad Ghasem Nezhad Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah, Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۵۵۶۱۶۴۹۸۳۱</zip>
        <telephone>+98 83 3828 2101</telephone>
        <email>sabamgm1992@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparous
Term of pregnancy
No previous experience of acupressure
Not having a lesion at the place of applying acupressure
Having no problems in speech, hearing and vision
No addiction
Not having known mental disorders
Not having crises such as divorce, loss of loved ones, immigration or... during the last 6 months.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to cooperate
Complications after natural delivery (heavy bleeding, embolism, etc.)
There is a need to receive additional painkillers outside of the usual department during the study (the usual painkillers of the department in case of severe back pain, diclofenac 100mg suppositories).</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Spleen point 6 acupressure: Acupressure intervention at spleen point 6 and intervention at Hugo point are applied bilaterally, in periods of 10 seconds of pressure and 2 seconds of rest for 20 minutes consecutively. The amount of applied pressure is such that the samples feel warm and have slight pain and pressure. Spleen pressure point 6 is in the Spleen meridian and is located 5 cm above the inner angle of the tibia, and the location of the Hugo point is anatomically in the back of the hand between the first and second metacarpal bones and almost along the radial bone.</i_keyword>
      <i_keyword>Hugo point acupressure:  Acupressure intervention at spleen point 6 and intervention at Hugo point are applied bilaterally, in periods of 10 seconds of pressure and 2 seconds of rest for 20 minutes consecutively. The amount of applied pressure is such that the samples feel warm and have slight pain and pressure. Spleen pressure point 6 is in the Spleen meridian and is located 5 cm above the inner angle of the tibia, and the location of the Hugo point is anatomically in the back of the hand between the first and second metacarpal bones and almost along the radial bone.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of labor pain. Timepoint: Before, immediately after and one hour after the intervention. Method of measurement: Visual Analouge Scale (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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-23</approval_date>
        <contact_name>Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah Province, Kermanshah, Beheshti Blvd Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
