<?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>IRCT20121230011944N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-13</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of uriculotherapy on the level of labor anxiety in primiparous women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of uriculotherapy on the level of labor anxiety in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>166</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43389</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Clinical trial, control group, non-blind, randomized.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Levels of labor anxiety in primiparous women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Uricholotherapy Intervention group: In the intervention group an Uricholotherapy technique was used by a researcher whose mother was in pain and had no pain, and the first time after 4 hours, which did not develop after an hour, and then at dilatation of 6 and 8 cm, in the ears of the ears on the masterpinette (2 points), uterine points (3 dots), prostaglandin points (2 dots), genital outer points (2 dots) using a pointer plate of Excel (2), pituitary gland (2 points) (Made in China). For every patient with a Pointer Plus device for 30 seconds, the listed points In both ears, it presses every 1 hour. Intervention 2: Control group: Clients do not receive any special sedation or techniques during labor and delivery.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Publish document as article

When:
Between the next 12 - 18 months

To whom:
All people

Conditions:
Notices

Where to obtain:
magazines

How to obtain:
online

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrnoush Ghaemmaghami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٣٨١٩٦٩٣٣٤٥</zip>
        <telephone>+98 86 3417 3502</telephone>
        <email>Mehrnoushghmghm68@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrnoush Ghaemmaghami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0000000000</zip>
        <telephone>+98 86 3417 3502</telephone>
        <email>Mehrnoushghmghm68@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparous women Containing low-risk pregnancy
Gestational age 40-37 weeks
Cephalic presentation
Single pregnancy
Age between 18-35 years
4/26&gt; BMI&gt; 8/19
Minimum literacy skills
Having at least one healthy ear
Has a healthy gestational sac
Mild anxiety (20-40 score according to Spielberger questionnaire)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>taking pain medication within 3 hours before and during the study
Drug addiction
Being an athlete
History of infertility
Illiteracy
Underlying disease associated with the auditory and ear canals
Medical disorder during pregnancy
Visit the center with a torn water bag
Dissatisfaction with continuing 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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Uricholotherapy Intervention group: In the intervention group an Uricholotherapy technique was used by a researcher whose mother was in pain and had no pain, and the first time after 4 hours, which did not develop after an hour, and then at dilatation of 6 and 8 cm, in the ears of the ears on the masterpinette (2 points), uterine points (3 dots), prostaglandin points (2 dots), genital outer points (2 dots) using a pointer plate of Excel (2), pituitary gland (2 points) (Made in China). For every patient with a Pointer Plus device for 30 seconds, the listed points In both ears, it presses every 1 hour.</i_keyword>
      <i_keyword>Control group: Clients do not receive any special sedation or techniques during labor and delivery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Anxiety in primiparous women. Timepoint: Before intervention, after intervention. Method of measurement: Speilberger Anxiety Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The Depression in primiparous women. Timepoint: Before intervention, after intervention. Method of measurement: Beck Depression Inventory II.</sec_outcome>
      <sec_outcome>The Anxiety in primiparous women. Timepoint: Before intervention, after intervention. Method of measurement: Speilberger Anxiety Inventory.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-18</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>Research Deputy, Supreme Prophet (pbuh) complex, Basij Square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
