<?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>IRCT20210120050092N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-19</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of stress and anxiety due to Covid 19 epidemic in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of "supportive" midwifery counseling on stress and anxiety Due to the Covid 19 epidemic in pregnant women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53834</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using the allocation sequence, which is generated based on the block method of volume 4, participants are randomly assigned to two groups. This method was used because people enter the study over time and in order to be assigned to the groups in proportion to the accident over time, and also by assigning one person to one group, it is not possible to guess which group the next person will belong to.
After generating the assignment sequence, each sequence letter (A, B) corresponds to a group. As participants enter the study from different centers, the central concealment method is used. The assignment sequence is placed in the hands of someone outside the research team. For each eligible person, after registering and entering the study, the desired person will be contacted and thus entered in a central list and will receive an identification code and assigned to the desired group.
•	1, 4, 1, Group B
•	1, 4, 2, Group B
•	1, 4, 3, Group A
•	1, 4, 4, Group A
•	2, 4, 1, Group B
•	2, 4, 2, Group A
•	2, 4, 3, Group A
•	2, 4, 4, Group B
•	3, 4, 1, Group A
•	3, 4, 2, Group B
•	3, 4, 3, Group B
•	3, 4, 4, Group A
•	4, 4, 1, Group A
•	4, 4, 2, Group B
•	4, 4, 3, Group B
•	4, 4, 4, Group A
•	5, 4, 1, Group B
•	5, 4, 2, Group B
•	5, 4, 3, Group A
•	5, 4, 4, Group A
•	6, 4, 1, Group A
•	6, 4, 2, Group B
•	6, 4, 3, Group B
•	6, 4, 4, Group A
•	7, 4, 1, Group B
•	7, 4, 2, Group A
•	7, 4, 3, Group A
•	7, 4, 4, Group B
•	8, 4, 1, Group B
•	8, 4, 2, Group B
•	8, 4, 3, Group A
•	8, 4, 4, Group A
•	9, 4, 1, Group B
•	9, 4, 2, Group B
•	9, 4, 3, Group A
•	9, 4, 4, Group A
•	10, 4, 1, Group B
•	10, 4, 2, Group A
•	10, 4, 3, Group B
•	10, 4, 4, Group A
•	11, 4, 1, Group B
•	11, 4, 2, Group A
•	11, 4, 3, Group B
•	11, 4, 4, Group A
•	12, 4, 1, Group B
•	12, 4, 2, Group A
•	12, 4, 3, Group A
•	12, 4, 4, Group B
•	13, 4, 1, Group A
•	13, 4, 2, Group B
•	13, 4, 3, Group A
•	13, 4, 4, Group B
•	14, 4, 1, Group A
•	14, 4, 2, Group A
•	14, 4, 3, Group B
•	14, 4, 4, Group B
•	15, 4, 1, Group A
•	15, 4, 2, Group A
•	15, 4, 3, Group B
•	15, 4, 4, Group B
•	16, 4, 1, Group B
•	16, 4, 2, Group A
•	16, 4, 3, Group B
•	16, 4, 4, Group A
•	17, 4, 1, Group B
•	17, 4, 2, Group A
•	17, 4, 3, Group A
•	17, 4, 4, Group B
•	18, 4, 1, Group B
•	18, 4, 2, Group B
•	18, 4, 3, Group A
•	18, 4, 4, Group A
•	19, 4, 1, Group B
•	19, 4, 2, Group B
•	19, 4, 3, Group A
•	19, 4, 4, Group A
•	20, 4, 1, Group A
•	20, 4, 2, Group A
•	20, 4, 3, Group B
•	20, 4, 4, Group B
•	21, 4, 1, Group A
•	21, 4, 2, Group B
•	21, 4, 3, Group B
•	21, 4, 4, Group A
•	22, 4, 1, Group B
•	22, 4, 2, Group A
•	22, 4, 3, Group A
•	22, 4, 4, Group B
•	23, 4, 1, Group B
•	23, 4, 2, Group A
•	23, 4, 3, Group A
•	23, 4, 4, Group B
•	24, 4, 1, Group A
•	24, 4, 2, Group A
•	24, 4, 3, Group B
•	24, 4, 4, Group B
•	25, 4, 1, Group B
•	25, 4, 2, Group B
•	25, 4, 3, Group A
•	25, 4, 4, Group A.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Stress caused by the Covid epidemic in pregnant women. Condition 2: Anxiety caused by the Covid epidemic in pregnant women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: pregnant women. Intervention 2: 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:
Regarding participants' personal data, information about the initial outcome is shared.

When:
Access time 6 months after the results are published.

To whom:
Researchers are allowed to receive data.

Conditions:
The use of available pain data to advance the objectives of the study is permitted.

Where to obtain:
They can be contacted via the following email to receive information.
mina_eteraf26@yahoo.com

How to obtain:
The applicant's request will be answered within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mina eteraf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>vahed 5,  sakhteman 111,  golbarg 5, Golha</address>
        <city>gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4915614731</zip>
        <telephone>+98 17 3213 3260</telephone>
        <email>mina_eteraf26@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mina eteraf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>vahed 5,  sakhteman 111,  golbarg 5, Golha</address>
        <city>gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4915614731</zip>
        <telephone>+98 17 3213 3260</telephone>
        <email>mina_eteraf26@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a health record in health centers
Pregnant women with a gestational age of 6 to 32 weeks
age range 35-18Sal
Primary education level up
Wanting to get pregnant
Mental disability
No hearing or vision problems
No addiction to cigarettes, drugs and alcohol
No recurrent miscarriage and history of infertility
Ability to participate in training classes if classes are held virtually
Access to cyberspace and the Intern</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>High-risk pregnancy (twin or multiple, threat of miscarriage, recurrent miscarriage, history of infertility, history of preterm or threatened preterm delivery, gestational diabetes, preeclampsia, bleeding)
History of serious psychiatric illness
History of anxiety problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_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</i_keyword>
      <i_keyword>Control group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Covid 19 stress in pregnant women. Timepoint: First before the intervention and then 4 weeks after the end of the intervention. Method of measurement: Corona Virus Stress Scale Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety caused by Covid 19 in pregnant women. Timepoint: First before the intervention and then 4 weeks after the end of the intervention. Method of measurement: Coronavirus Anxiety Scale 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-07</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud University of Medical Sciences and Health Services- 7th of Tir Square- Shahroud shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
