<?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>IRCT20210622051671N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-31</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of Emotional Freedom Technique on fear of childbirth in nulliparous women</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Emotional Freedom Technique on fear of childbirth in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>116</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57057</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of assigning the intervention to individuals is random and in the method of random permutation blocks with block size 6 (using the table related to random permutations) and with a ratio of 1: 1. The randomization list is prepared by a statistician. The codes assigned to the eligible individuals will be placed in sealed envelopes by an out-of-study person who is unaware of the research objectives and will be provided to the secretary of the clinic. They will not know who is in which group, Blinding description: The codes assigned to the eligible individuals will be placed in sealed envelopes by an out-of-study person who is unaware of the research objectives and will be provided to the secretary of the clinic. They will not know who is in which group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fear of childbirth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Tapping the parts of the face and body with the fingertips, which include: the beginning of the eyebrows (above the nose), the sides of the eyes (on the outer bone of the eye), the under eyes (on the cheeks and 2-3 cm Meters below the eye socket), under the lips (in the short distance between the nose and the upper lip), chin (in the middle of the distance between the chin and the lower lip), clavicle (from the U-shaped bone below the throat 2-3 cm down and 2-3 cm Meters to the sides) and armpits (10 cm below the armpits). Intervention 2: Control group: This group also strikes with their fingers using false points, ie points other than the points of acupressure introduced.</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 I do not have a plan at the moment</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Fatemeh Emadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan St., Razi School of Nursing and Midwifery</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135733337</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>s.fatemehemadi74@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khadijeh Hekmat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan St., Razi School of Nursing and Midwifery</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135733337</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>Hekmat1346@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum primary education
Gestational age 28 to 30 weeks
Nulliparous
Earn more than 37 points in the Vijama questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Chronic diseases such as heart disease, high blood pressure, diabetes
History of abortion
Placenta previa
Suffering from mental illness during the last year and taking psychotropic drugs
Drug and smoking addiction
Pregnancy complications such as preeclampsia, bleeding, intrauterine death, preterm delivery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Phobic anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Tapping the parts of the face and body with the fingertips, which include: the beginning of the eyebrows (above the nose), the sides of the eyes (on the outer bone of the eye), the under eyes (on the cheeks and 2-3 cm Meters below the eye socket), under the lips (in the short distance between the nose and the upper lip), chin (in the middle of the distance between the chin and the lower lip), clavicle (from the U-shaped bone below the throat 2-3 cm down and 2-3 cm Meters to the sides) and armpits (10 cm below the armpits).</i_keyword>
      <i_keyword>Control group: This group also strikes with their fingers using false points, ie points other than the points of acupressure introduced.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of childbirth score in Vijma childbirth fear questionnaire. Timepoint: At the beginning of the study (before the intervention) with Vijma Maternity Fear Questionnaire version A and at the end of the intervention (first postpartum visit) with Vijama Maternity Fear Questionnaire version B. Method of measurement: Vijma Childbirth Fear Questionnaire version A and B.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-15</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Golestan St., Ahvaz Jundishapur University of Medical Sciences, Razi School of Nursing and Midwifery Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
