<?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>IRCT20150119020719N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-29</date_registration>
      <primary_sponsor>Research Assistant Alborz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of counseling on Anxiety and Self-Efficacy in Coping with Child Birth in Pregnant Women</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect  of consultation based on the Pregnant mothers mind consciousness on Anxiety and Self-Efficacy In compliance with childbirth in Pregnant Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29244</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Use the random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Consultation on reducing the amount of stress based on mindfulness. Holding 6 training sessions of 60 minutes. The sessions are as follows: Session 1: Research objectives, Mindfulness definition, Self-efficacy definition, Anxiety definition. Session 2: An explanation of the process of delivery, Maternal pain, ways to reduce labor pain, and review the techniques of mindfulness, consciousness in sitting, relaxed sleep, third session: Expression of mothers' experiences, strategies for reducing their anxiety, reviewing techniques, conscious breathing in sitting position, relaxing tone And relaxation, fourth session: teaching relaxation and explaining the activity of the home Fifth: Examination of homework, training on respiratory control training and respiratory meditation. Session Six: Review assignments, review previous sessions. Intervention 2: Control group receives  during pregnancy  routine care included pregnancy examination, fetal heart rate and all of recommended program in ministry of health and medical education guideline (after the end of  consulting session in interventional group to observe  ethics research booklet, containing advice, will be provided to the control group).</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:
All participants data can be shared after being unidentified

When:
Start the access period after publishing the results

To whom:
Public

Conditions:
For use in studies

Where to obtain:
Masoumeh Zare Nejad m13 zare64@gmail.com-09128815318

How to obtain:
The application will be sent to the project implementer by email and within 24 hours will receive the necessary item

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Esmaelzadeh Saeieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,first Golestan,Alborz</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098</zip>
        <telephone>+98 912 623 2569</telephone>
        <email>esmaelzadeh1360@gmail.com</email>
        <affiliation>Research Assistant Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Esmaelzadeh Saeieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz University of medical sciences -school of nursing and midwifery- first Golestan-Baghestan</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098</zip>
        <telephone>+98 26 3433 6007</telephone>
        <email>esmaelzadeh1360@gmail.com</email>
        <affiliation>Alborz University of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian
Fluent in Persian
first pregnancy
planned pregnancy
gestational age of 28-34 weeks
single pregnancy
in the absence of  known disease or psychological problems</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Non-participation in 2 Full Sessions of Counseling for Known Medical Conditions
Psychosocial Problems
Abortion History
Intrauterine Death
Maternity Company in Childbirth Classes
Occurrence of Preterm Delivery
Participants in Yoga classes, Relaxation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Consultation on reducing the amount of stress based on mindfulness. Holding 6 training sessions of 60 minutes. The sessions are as follows: Session 1: Research objectives, Mindfulness definition, Self-efficacy definition, Anxiety definition. Session 2: An explanation of the process of delivery, Maternal pain, ways to reduce labor pain, and review the techniques of mindfulness, consciousness in sitting, relaxed sleep, third session: Expression of mothers' experiences, strategies for reducing their anxiety, reviewing techniques, conscious breathing in sitting position, relaxing tone And relaxation, fourth session: teaching relaxation and explaining the activity of the home Fifth: Examination of homework, training on respiratory control training and respiratory meditation. Session Six: Review assignments, review previous sessions</i_keyword>
      <i_keyword>Control group receives  during pregnancy  routine care included pregnancy examination, fetal heart rate and all of recommended program in ministry of health and medical education guideline (after the end of  consulting session in interventional group to observe  ethics research booklet, containing advice, will be provided to the control group).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Consultation Based on self- mindfulness. Timepoint: Before the intervention, After the intervention, two week after the intervention. Method of measurement: Freiburg Mindfulness Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention, After the intervention, two week after the intervention. Method of measurement: Pregnancy Related Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy in coping with child birth. Timepoint: Before the intervention, After the intervention, two week after the intervention. Method of measurement: self-efficacy in coping with child birth questionnaire.</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>Research Assistant Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-22</approval_date>
        <contact_name>Ethics committee of  Alborz University of Medical Sciences</contact_name>
        <contact_address>Vice-Chancellor for Research and Technology,Alborz University of Medical Sciences,above Taleghani Square,Taleghani Square,karaj,alborz,Iranlborz, Iran karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
