<?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>IRCT20170503033796N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-21</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparative study of the scalp acupressure on the pain and the ability to cope with pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparsion of pressure in the bladder-Gv20 and Gall bladder-GV20 on Intensity Labour Pain and Coping among Primiparturient Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>165</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25982</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, each of the units was selected as available and then random allocation (assignment for the three primary patients in 3 groups was randomized and the same order was observed for other patients until the end of the study) in 3 groups of intervention and control they got, Blinding description: With regard to the LDR's rooms, none of the research units were in contact with each other, and thereforethey were not aware of the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Labor pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:With each contraction points of  GV20-BL5-BL8-BL9 is pressed for 60 seconds (a total of 4 minutes). The compressor was housed half an hour at the beginning of the contraction and in a 4-minute cycle (60 seconds each) for 5 consecutive cycles. In the latent phase of the second stage of labor, with the onset of uterine contraction, a pressure cycle is applied to each of the points. Intervention 2: Intervention group: With each contraction points of  GV20- GB8-GB16-GB17-GB18 is pressed for 60 seconds (a total of 4 minutes). The compressor was housed half an hour at the beginning of the contraction and in a 4-minute cycle (60 seconds each) for4 consecutive cycles. In the latent phase of the second stage of labor, with the onset of uterine contraction, a pressure cycle is applied to each of the points. Intervention 3: Control group: Caring for the usual maternity ward at U-Al-Banin Hospital includes taking a vegan, helping in changing clothes, bedding, pads, hearing a fetal heart's sound every half hour.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is We do not plan to publish information about the participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elaheh Mansouri Ghezel Hesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Doktora Crossroads, Ebne Sina Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3589 1511</telephone>
        <email>mansourie941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Kordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Nursing Midwifery Faculty, Doktora Crossroads, Ebne Sina Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>KordiM@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Muslims and Iran
Age from 18 to 35 years old
Written Consent Form
nulliparous
singleton pregnancy
cephalic fetal presentation
gestational age  37 weeks and more
Fit the head of the fetus with the mother's hip
fetal weight  between 4000-2500 grams
Spontaneous onset of labor (5-4 cm dilated with contractions 20 seconds and at least two more within 10 min)
healthy skin pressure areas
Pain intensity is 50 or more at the start of the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Speech-auditory or dialectal problems
Drug Addiction, Drinking and Tobacco
History of referral to a psychiatrist or psychologist, drug use or hospitalization due to mental illness in the past year
Major stress in the last year
Cure for medical conditions
Decided to cesarean section
The presence of midwifery problems
History of operation on the uterus or cervix
Use of a prescription by a doctor or midwife or herbal medicine within the last 24 hours for the onset of labor pain
Oral temperature equal to or greater than 38 ° C
Severe anxiety at the start of the study</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>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:With each contraction points of  GV20-BL5-BL8-BL9 is pressed for 60 seconds (a total of 4 minutes). The compressor was housed half an hour at the beginning of the contraction and in a 4-minute cycle (60 seconds each) for 5 consecutive cycles. In the latent phase of the second stage of labor, with the onset of uterine contraction, a pressure cycle is applied to each of the points.</i_keyword>
      <i_keyword>Intervention group: With each contraction points of  GV20- GB8-GB16-GB17-GB18 is pressed for 60 seconds (a total of 4 minutes). The compressor was housed half an hour at the beginning of the contraction and in a 4-minute cycle (60 seconds each) for4 consecutive cycles. In the latent phase of the second stage of labor, with the onset of uterine contraction, a pressure cycle is applied to each of the points.</i_keyword>
      <i_keyword>Control group: Caring for the usual maternity ward at U-Al-Banin Hospital includes taking a vegan, helping in changing clothes, bedding, pads, hearing a fetal heart's sound every half hour</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coping with Labor Pain. Timepoint: Before the intervention and a half hours until delivery. Method of measurement: Observational questionnaire of coping with labor pain.</prim_outcome>
      <prim_outcome>Labor pain. Timepoint: Before the intervention and a half hours until delivery. Method of measurement: Visual analog scale pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Labor progress. Timepoint: From the time of admission (5-4Santy dilation of the cervix) until delivery. Method of measurement: Partogragh modified World Health Organization.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-22</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Unit 1, Ghoreshi building, Daneshgah Street, Mashhad, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
