<?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>IRCT20211030052913N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-25</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>effect of positive approach on the worries</public_title>
      <acronym></acronym>
      <scientific_title>effect of counseling with a positive approach on the worries of pregnant women with a history of prenatal loss</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59680</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: For Randomization The Block Method With Volume 4 Was Used To Create The Allocation Sequence; With Envelopes Were Used To Hind The Sequence; Each Sequence Is Placed Inside a White Envelope and The Envelopes Are Placed Side By Side; Each Envelope Is Numbered; An Envelope Is Opened For  Each Person In The Order Of Their Entry In To  The Study And Is Assigned To The Desired Group, Blinding description: Gather Information to Blind The Individual Before Assigning Individual to Groups Basic Questionnaires Are Completed For Participants; After Interference 'It Is Done By a Person Who Is Not Aware Of The Group; The Data Analyst Is Also Not From The Study Group; Participants Are Trained And Fill Out Informed Consent Forms; They Know Their Group From The Beginning.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Investigation of Concerns In Pregnant Women With a History Of Fetal Loss.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pregnant Women With a History of Fetal Loss-The intervention is a group and lasts from 12 to 30 weeks of pregnancy and counseling sessions once a week for four weeks for 60 to 90 minutes. For screening patients with mental disorders before random allocation, along with the Pregnancy Concern Questionnaire, the Pennsylvania Questionnaire is given so that patients with mental disorders can be isolated and only mothers with pregnancy concerns can be included in the study. Intervention 2: Control group: The control group will receive 4 sessions of nutrition training during pregnancy and counseling sessions will be held in groups.</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:
Data Can Be Shared After People Are Not Identified

When:
Access Period Starts 6 Months After The Results Are Published

To whom:
All Employed and Students In Academic Institutions and Pregnant Women

Conditions:
To Reduce The Anxiety Of Pregnant Women With Fetal Loss Problems To Help Them Reduce Anxiety And Get Pregnant

Where to obtain:
-----

How to obtain:
----

Comments:
----</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>somaye ghods</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.90-1;Sixth Street; Abozar Blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3516878457</zip>
        <telephone>+98 23 3332 8777</telephone>
        <email>Somayeghods@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somaye ghods</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.90-1;Sixth  Street; Abozar Blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3516878457</zip>
        <telephone>+98 23 3332 8777</telephone>
        <email>Somayeghods@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant Women With a Gestational Age of 12 to 30 Weeks
Pregnant Mother Over 18 Years Old
Normal Pregnancy and High risk non Pregnancy
Single
History of Late Abortion- Still Birth or Infant Death In a Previous Pregnancy
Ability to Complete The Questionnaire
Ability to Speak Persian</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The Arrival of Any Social Crisis Such As The Death Of a Loved One
Incidence Of Physical Problems and Serious Illness In The Last Six Months</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pregnant Women With a History of Fetal Loss-The intervention is a group and lasts from 12 to 30 weeks of pregnancy and counseling sessions once a week for four weeks for 60 to 90 minutes. For screening patients with mental disorders before random allocation, along with the Pregnancy Concern Questionnaire, the Pennsylvania Questionnaire is given so that patients with mental disorders can be isolated and only mothers with pregnancy concerns can be included in the study.</i_keyword>
      <i_keyword>Control group: The control group will receive 4 sessions of nutrition training during pregnancy and counseling sessions will be held in groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Primary Outcome Is To Measure The Anxiety And Happiness Of Pregnancy. Timepoint: In the intervention group, a positive counseling program will be performed during one month. At the end of one month, the mothers' concern will be measured again using a questionnaire. Method of measurement: First, Dr. Navidpour's anxiety questionnaire and Seligman positivity questionnaire and for screening patients with mental disorders, the Pennsylvania questionnaire will be provided to mothers with inclusion criteria.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>There Is No Secondary Variable. Timepoint: ---. Method of measurement: ---.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-30</approval_date>
        <contact_name>Ethic Committee of Shahrod University of Medical Sciences</contact_name>
        <contact_address>No.1-90, Sixth Street, Abozar Blvd,semnan Town semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
