<?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>IRCT20201209049657N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-29</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of supportive group therapy on fear of childbirth, tendency to type of childbirth and happiness of pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of midwifery " Supportive group therapy " on fear of delivery, Tendency to type of delivery and happiness in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52898</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using the allocation sequence that was produced based on the block method to volume 4. First, the city is divided into three regions in terms of socio-economic, then one center is selected at random from each region, and people are selected at random from each center, Blinding description: Due to the nature of the study, it is not possible to blind the participants.
However, the data collector (person completing the questionnaire) will not be aware of the group of people. Thus, pre-intervention questionnaires are administered before random assignment of individuals to groups. After the intervention, the data collector is not aware of the group of people. The statistical analyzer will also be unaware of the group of people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: . Condition 2: . Condition 3: .</hc_freetext>
      <i_freetext>Intervention 1: My intervention group consists of 5 groups of nine people who, in addition to participating in supportive therapy groups, also participate in offline training classes that are matched with the control group and complete a questionnaire. Supportive group therapy will be performed in 5 one-hour sessions per week for the intervention group. The group leader is the project manager himself, who is a graduate student in midwifery counseling, and the assistant midwife treatment partner has experience in natural childbirth. If a session is held to discuss unspecified topics, a session will be added to it. .) And Introducing the treatment method Session 2: Discussion and education about the benefits and complications of natural childbirth Session 3: Discussion and education about the complications of cesarean delivery Session 4: Skills training and stress management Muscle relaxation) Session 5: Reviewing the previous sessions, summarizing, completing the questionnaire. Will be asked before and after the intervention. Intervention 2: The control group consists of 5 groups of 9 people. Before the intervention and after the intervention, they will fill out the Vijma and Oxford Maternity Fear Questionnaire and will be asked about the desire for the type of delivery before participating in the research and after participating in the research. They will also participate in offline training classes.</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:
The data of each questionnaire and interviews with individuals who are not known due to blindness belong to whom.
However, the data can be published if it is clear that it belongs to the  intervention group or the control. Data related to the main outcome, etc. can also be published .In fact, all the data that we have, including questionnaires, etc., can be published.

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

To whom:
The project data and documentation can be used by researchers working in academic and scientific institutions, as well as people working in health centers and hospitals and management systems and private offices.

Conditions:
The documentary can be used for further research and development of science in this field or for work in a private office, etc.

Where to obtain:
To receive data and documents, contact Ms. Seyedeh Zahra Mousavi, the project manager, at the email address Seyedezahramousavi87311@gmail.com and the mobile number 09112788820 and the postal address of 12th Gol Alley, Pasdaran St, Golestan province  and postal code 4881878879.

How to obtain:
The request for data will be provided to the applicant immediately upon observation by the developer.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley Gol12, Pasdaran St</address>
        <city>Kordkoy</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4881878879</zip>
        <telephone>+98 17 3434 7488</telephone>
        <email>Seyedezahramousavi87311@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedezahra Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gol Alley 12, Pasdaran Street.</address>
        <city>Kordkoy</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4881878879</zip>
        <telephone>+98 17 3434 7488</telephone>
        <email>Seyedezahramousavi87311@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Prefer cesarean delivery or be hesitant about choosing the type of delivery.
Be the first and single pregnancy
No history of recurrent miscarriage.
Be at least literate.
Her gestational age at the beginning of the study should be 22-30.
The fetus is healthy and normal in the first trimester ultrasound examinations.
Have computer information if the class is held virtually
There are no obvious and recognizable barriers to normal delivery at the time of sampling.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Have an addiction to alcohol, cigarettes and drugs.
Have a history of recurrent miscarriage or infertility.
Have a neurology and psychiatry Disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>My intervention group consists of 5 groups of nine people who, in addition to participating in supportive therapy groups, also participate in offline training classes that are matched with the control group and complete a questionnaire. Supportive group therapy will be performed in 5 one-hour sessions per week for the intervention group. The group leader is the project manager himself, who is a graduate student in midwifery counseling, and the assistant midwife treatment partner has experience in natural childbirth. If a session is held to discuss unspecified topics, a session will be added to it. .) And Introducing the treatment method Session 2: Discussion and education about the benefits and complications of natural childbirth Session 3: Discussion and education about the complications of cesarean delivery Session 4: Skills training and stress management Muscle relaxation) Session 5: Reviewing the previous sessions, summarizing, completing the questionnaire. Will be asked before and after the intervention.</i_keyword>
      <i_keyword>The control group consists of 5 groups of 9 people. Before the intervention and after the intervention, they will fill out the Vijma and Oxford Maternity Fear Questionnaire and will be asked about the desire for the type of delivery before participating in the research and after participating in the research. They will also participate in offline training classes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of childbirth. Timepoint: This variable will be measured before the start of the study and after the intervention. Method of measurement: Vijma Maternity Fear Questionnaire.</prim_outcome>
      <prim_outcome>Tendency to type of delivery. Timepoint: This variable will be measured before the start of the study and after the intervention. Method of measurement: By asking pregnant women about their desire for childbirth.</prim_outcome>
      <prim_outcome>Happiness. Timepoint: This variable will be measured before the start of the study and after the intervention. Method of measurement: Through the Oxford Happiness 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>Vice Chancellor for Research, Shahroud 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 Shahroud University of Medical Sciences</contact_name>
        <contact_address>12th flower alley, Pasdaran street Kordkuy Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
