<?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>IRCT20220125053827N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-26</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Investigating  the  effect of  Solution-Focused group counseling on anxiety in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Investigating  the  effect of  Solution-Focused group counseling on anxiety in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61862</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: Examining the interventions performed to reduce pregnancy anxiety, whether solution-oriented, etc., it was found that in these studies, a specific population of pregnant women were studied, for example, Noli Par women who were afraid of childbirth or Noli Par women. Many of these studies also used general anxiety questionnaires to measure pregnancy anxiety, such as the Spielberger Anxiety Inventory, the Hamilton Anxiety Rating Scale, the Cohen Perceived Stress Scale, and the Beck General Anxiety Inventory. It is clear that the study of multiparous women, as a large proportion of pregnant women, has been neglected, while the results of a study showed that multiparous women were 36% more anxious than nulliparous women.Another important point is to use a special questionnaire to measure pregnancy anxiety. General Anxiety Questionnaires are designed to measure general anxiety and their items are not able to measure pregnancy-related anxiety. Therefore, there is a need to conduct studies that include women with multiple pregnancies and a specific questionnaire of appropriate pregnancy anxiety has been used. Therefore, in this study, the short form of the revised Pregnancy Anxiety Questionnaire Edition 2 (PRAQ-R2) was used and the study population includes nulliparous and multiparred women, Randomization description: In the present study, the block randomization method will be used (20 to 4 blocks), in each block, two allocations for the control group and two allocations for the intervention group are considered. Random sequence generation will be done using the site (https://www.sealedenvelope.com)  . The list of random allocation sequences is then made available to an individual outside the research team. As soon as a person is eligible to attend the study, the sampler contacts the person with the random assignment sequence and, in turn, according to the sequence list, gives the participants a code to enter the study, thus hiding the sequence. Will be the central method, Blinding description: Completion of the questionnaire in the post-test stage is done by interviewers who are unaware of how people are placed in the two groups and do not know the statistical consultant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pregnancy Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intervention group: The intervention group will receive 5 sessions of solution-oriented group counseling, one session per week on an even day of the week (Saturday or Monday or Wednesday) for 5 consecutive weeks. Each session will last 90 minutes. Since the consultation is held in groups, the number of people in each group is 10 and we will have a total of 4 groups of 10 people (40 people). Solution-oriented group counseling sessions will be in accordance with the solution-oriented treatment protocol (including: introduction - goal setting - eliminating the disruptive pattern of behavior with miraculous questions - creating solutions - consolidating solutions - summarizing and concluding) They do not receive any intervention. Intervention 2: Control group: The control group did not receive any intervention.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not made a decision yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Mazraei Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koshtargah Street Shahid Vahidolah Rezaei Ave</address>
        <city>اراک</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3816787916</zip>
        <telephone>34253295</telephone>
        <email>f.mazraeifarahani@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fatemeh mazraei farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>koshtargah street, Shahid Vahidollah Rezaei alley</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3816787916</zip>
        <telephone>+98 86 3425 3295</telephone>
        <email>f.mazraeifarahani@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18-35 years, at least fifth elementary education, gestational age (29-32) weeks, obtaining a score of  18 from the short form of the revised Pregnancy Anxiety Questionnaire Edition 2, singleton pregnancy, no history of infertility and use of assisted reproductive techniques , Pregnant mother's desire to participate in research, no smoking, alcohol and drug addiction, no history of hospitalization in the psychiatric ward, no use of psychiatric drugs  at present and during the intervention, no use of propranolol, no participation in similar intervention , No occurrence of stressful events during the last 6 months, resident of Arak city and no diseases or medical records and disorders that make pregnancy high risk.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to cooperate, absence from more than one session, experience of stressful events (death of a spouse, death of a loved one), occurrence of any complications that make pregnancy dangerous (gestational diabetes, preeclampsia, preterm (onset of labor pains before 37 weeks Complete pregnancy), bleeding, intrauterine death).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O99.345</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other mental disorders complicating the puerperium</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:Intervention group: The intervention group will receive 5 sessions of solution-oriented group counseling, one session per week on an even day of the week (Saturday or Monday or Wednesday) for 5 consecutive weeks. Each session will last 90 minutes. Since the consultation is held in groups, the number of people in each group is 10 and we will have a total of 4 groups of 10 people (40 people). Solution-oriented group counseling sessions will be in accordance with the solution-oriented treatment protocol (including: introduction - goal setting - eliminating the disruptive pattern of behavior with miraculous questions - creating solutions - consolidating solutions - summarizing and concluding) They do not receive any intervention.</i_keyword>
      <i_keyword>Control group: The control group did not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pregnancy Anxiety. Timepoint: Before and immediately after the intervention. Method of measurement: Using the Revised Pregnancy Anxiety Questionnaire Form 2 (PRAQ-R2).</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>No</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-15</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Slaughterhouse Street, Shahid Vahidollah Rezaei Alley, Postal Code 3816787916 Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
