<?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>IRCT20181219042051N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-20</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>the Effect of Acupressure at GB21 on Childbirth Experience During First Stage of Labour</public_title>
      <acronym></acronym>
      <scientific_title>the Effect of Acupressure at GB21 on Childbirth Experience During First Stage of Labour, a clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>192</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87784</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the inclusion and exclusion criteria, 192 pregnant women at 37-42 weeks of gestation who were eligible to enter the study were selected using an available sampling method. They will be divided into three equal groups of 64 individuals using blocked randomization with a block size of six (via the computer program "CREATE A RANDOMISATION LIST"). In other words, 32 blocks of six individuals will be formed. Within each block, two individuals will be randomly assigned to the first group (APG), two to the second group, and two to the third group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>birth experience.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: first. acupuncture point pressure                                               In the acupressure group (APG), participants will be positioned appropriately and the GB21 acupressure point will be pressed by a trained specialist. The Gallbladder 21 point is located on the gallbladder meridian, and its anatomical position is on the shoulder, midway between the acromion bone and the seventh cervical vertebra.  Pressure will be applied starting from the onset of contractions (3-4 cm cervical dilation) and continued throughout the active phase of labor (7-8 cm cervical dilation) until the end of the first stage of labor.  During the procedure, in the GB21 pressure group, the mother will be asked to assume any comfortable position. The intervening midwife will stand facing the mother and monitored her uterine contractions by hand to detect their onset. At the start of each contraction, the two symmetrical target points will be pressed simultaneously and symmetrically with both hands, five times in a row. Each press will laste 10 seconds, followed by a 2-second release and rest period. The intervener aime to apply a consistent and equal amount of pressure each time. Any difference in pressure applied by the left and right thumbs will be minimized through practice and training. Intervention 2: Intervention group: second. acupuncture point touch                                              In the sham acupressure group (TG), the target point will only touch and not pressed. Intervention 3: Control group: routine care                                                                                    the control group will receive just routine care.</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>Zohreh Ghorashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Street</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>771869669</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>zghorashi@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh Ghorashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Street</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>771869669</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>zghorashi@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
gestational age of 37-42 weeks
maternal age of 18-45 years
ability to speak Persian
absence of high-risk pregnancies (gestational hypertension, reduced fetal movements, intrauterine growth restriction, fetal death, poly- or oligohydramnios, rupture of membranes for more than 12 hours, history of infertility, gestational diabetes, smoking)
absence of chronic diseases (heart disease, lung disease, diabetes, and hypertension)
cephalic presentation of the fetus
absence of an accompanying midwife
no history of physical, surgical, or psychological problems
no issues during pregnancy
singleton pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to cooperate during the interview
need for emergency cesarean section
use of pain relief methods.</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: first. acupuncture point pressure                                               In the acupressure group (APG), participants will be positioned appropriately and the GB21 acupressure point will be pressed by a trained specialist. The Gallbladder 21 point is located on the gallbladder meridian, and its anatomical position is on the shoulder, midway between the acromion bone and the seventh cervical vertebra.  Pressure will be applied starting from the onset of contractions (3-4 cm cervical dilation) and continued throughout the active phase of labor (7-8 cm cervical dilation) until the end of the first stage of labor.  During the procedure, in the GB21 pressure group, the mother will be asked to assume any comfortable position. The intervening midwife will stand facing the mother and monitored her uterine contractions by hand to detect their onset. At the start of each contraction, the two symmetrical target points will be pressed simultaneously and symmetrically with both hands, five times in a row. Each press will laste 10 seconds, followed by a 2-second release and rest period. The intervener aime to apply a consistent and equal amount of pressure each time. Any difference in pressure applied by the left and right thumbs will be minimized through practice and training.</i_keyword>
      <i_keyword>Intervention group: second. acupuncture point touch                                              In the sham acupressure group (TG), the target point will only touch and not pressed.</i_keyword>
      <i_keyword>Control group: routine care                                                                                    the control group will receive just routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Birth experience. Timepoint: one hour after birth. Method of measurement: Childbirth Experience Questionnaire Ghanbari-Homayi.</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>2025-03-11</approval_date>
        <contact_name>Rafsanjan University of medical sciences ethics committee</contact_name>
        <contact_address>Parastar Street Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
