<?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>IRCT20210827052302N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-12</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of midwifery counseling on anxiety and lifestyle in pregnant women who have experienced abortion.</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Supportive Care Counseling on Anxiety and Quality of Life of Pregnant Women with a History of Abortion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58469</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In the first stage, which is the stage of selecting samples, the class is done in such a way that first a list of comprehensive health centers in different areas of Isfahan is prepared and then two centers are randomly selected in each area. Then, the number of clients in each center Determine the eligibility of the study and then the estimated sample size in relation to the number of clients in each center is determined, then in each center by   blocks with size 4 with the help of https://www.sealedenvelope.com. And control allocation It should be noted that to hide the random allocation stage will be done by someone other than the researcher.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Spontaneous Abortion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Pregnant Mothers who have been Confirmed by their Pregnancy Ultrasound and have Registered their Pregnancy History in a Comprehensive Health Center and have Inclusion Criteria and have been randomly Placed in the Intervention Group,  Details of the Plan will be Contacted. They are Invited to Participate in this Project. In the first Session of their Presence in the Center after Obtaining Satisfaction and Completing the Demography questionnaire and Wendenberg pregnancy Anxiety Questionnaire and the Wire and Sherbon Quality of Life Questionnaire, the first Counseling Session based on 5 Stages of Swanson Theory is held with the Presence of the Center Psychologist. a week later, second session and The third Week, the third Session is held and 4 Weeks and 8 Weeks after the Intervention, the Questionnaires are Completed again by the Intervention Group. Intervention 2: Control Group: Pregnant Mothers who have been Confirmed by their Pregnancy Ultrasound and have filed a Pregnancy Record at the Comprehensive Health Center and have inclusion criteria and have been randomly placed in the control group will be contacted and the details of the plan will be explained. They are invited to participate in the project. In the first session of their presence in the center after obtaining consent, they complete the Demographic and Wendenberg Pregnancy Anxiety Questionnaire and the Wire and Sherbon Quality of Life Questionnaire. This group does not receive any intervention and 4 and 8 weeks after the end of the intervention, the Wendenberg Pregnancy Anxiety Questionnaire and the quality of life of Wire and Sherbon are completed by this 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:
Information about the main outcome is shared.

When:
Access period starts 6 months after the results are published

To whom:
All researchers, midwives and doctors

Conditions:
Documentary researchers can be used for scientific advancement. It is possible to access the data by sending an email to the supervisor. Email shivakheirkhah1345@gmail.com

Where to obtain:
Scientific responsible for studying Masoumeh Kheirkhah Email shivakheirkhah1345@gmail.com

How to obtain:
After confirmation of the research assistant by email to the supervisor email shivakheirkhah1345@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>dr Masoomeh kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Rashid Yasemi St, Above of Vanak Sq, Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>shivakheirkhah1345@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr Masoomeh kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Rashid Yasemi St, Above of Vanak Sq, Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>shivakheirkhah1345@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a Current Gestational Age of 8 Weeks and more with Ultrasound Approval
Wanted Current Pregnancy
Having a Miscarriage under 20 Weeks in a Previous Pregnancy in the Past Year
No History of Specific Mental Illness
Minimum Literacy
Not Having a Living Child in the Family</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to Continue Participating in the Study
Loss Of Pregnancy
Occurrence of Unfortunate Events and Great Stress During the Intervention such as the Loss of Loved Ones
Immigration of the Pregnant Mother</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>003</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spontaneous abortion</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Pregnant Mothers who have been Confirmed by their Pregnancy Ultrasound and have Registered their Pregnancy History in a Comprehensive Health Center and have Inclusion Criteria and have been randomly Placed in the Intervention Group,  Details of the Plan will be Contacted. They are Invited to Participate in this Project. In the first Session of their Presence in the Center after Obtaining Satisfaction and Completing the Demography questionnaire and Wendenberg pregnancy Anxiety Questionnaire and the Wire and Sherbon Quality of Life Questionnaire, the first Counseling Session based on 5 Stages of Swanson Theory is held with the Presence of the Center Psychologist. a week later, second session and The third Week, the third Session is held and 4 Weeks and 8 Weeks after the Intervention, the Questionnaires are Completed again by the Intervention Group.</i_keyword>
      <i_keyword>Control Group: Pregnant Mothers who have been Confirmed by their Pregnancy Ultrasound and have filed a Pregnancy Record at the Comprehensive Health Center and have inclusion criteria and have been randomly placed in the control group will be contacted and the details of the plan will be explained. They are invited to participate in the project. In the first session of their presence in the center after obtaining consent, they complete the Demographic and Wendenberg Pregnancy Anxiety Questionnaire and the Wire and Sherbon Quality of Life Questionnaire. This group does not receive any intervention and 4 and 8 weeks after the end of the intervention, the Wendenberg Pregnancy Anxiety Questionnaire and the quality of life of Wire and Sherbon are completed by this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: The beginning of the study and 4 and 8 week after end of study. Method of measurement: Pregnancy Related Anxiety Questionnaire Vanden Berg 1989.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: The beginning of the study and 4 and 8 week after end of intervention. Method of measurement: Ware and Sherbourne questionnaire ( SF-36 ).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-07</approval_date>
        <contact_name>Ethics committee of Iran University of medical Sciences</contact_name>
        <contact_address>5th Floor, Headquarters, Iran University of Medical Sciences, Between Chamran and Sheikh Fazlolah streets, Hemat Hwy Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
