<?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>IRCT20191001044945N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-02</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of life skills training on pregnancy anxiety</public_title>
      <acronym>LSTAP</acronym>
      <scientific_title>Effect of life skills training on pregnancy anxiety in pregnant women over 30 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>43</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42853</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After receiving the code of ethics and obtaining a license from Ahvaz Jundishapur University of Medical Sciences, Abadan University of Medical Sciences, six clinics were randomly selected by submitting it to Abadan clinic centers and bases.
 Pregnant women referred to 3 clinics as intervention group and 3 clinics as control group were included in the study.
These centers were selected from health centers of the three socio-economic zones of Abadan city, 2 centers from each district.
 Thus, two centers were selected from the prosperous area, 2 medium and 2 low, and each center was assigned one intervention group and one control group.
The specimens were examined by referring to existing system files and then by telephone or in-person referral to clinics and the inclusion criteria were assessed.
Then, 180 questionnaires were given to pregnant women referring to these clinics, who were eligible for inclusion in the study, Wendenberg Pregnancy Anxiety Questionnaire.
The researcher received written informed consent in an individual interview with each pregnant mother after introducing herself and providing a fuller description of the aims and method of study of the participant with inclusion criteria and assurance of confidentiality.
After explaining how to complete the questionnaires, at the same place the questionnaire was completed by pregnant women and only 86 women out of all women who had received the Wendenberg Anxiety Inventory completed pregnancy anxiety scores between 280 and 160 for the intervention group (43). - Control (43) subjects were selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pragnancy Anxity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The present quasi-experimental study consists of three parts: pre-test, intervention and post-test. When the initial questionnaires were completed by pregnant women.Based on the inclusion criteria, the intervention group was divided into 5 groups, each consisting of 3 to 4 persons, and for each group, life skills training was conducted separately by the researcher in a face-to-face workshop. In the life skills training sessions, the researcher first obtained information through question and answer, group discussion, brainstorming from mothers' knowledge and attitudes about those topics, and then through lecture methods and PowerPoint presentations to better understand her topics. The session was offered to pregnant mothers, and each training session was organized as a workshop with the participation of pregnant women.It should be noted that in order to make the training more effective and effective, and taking into account the specific circumstances of the pregnant women during the week, virtual training was provided in the WhatsApp groups.These tutorials included relaxation exercise videos, reviewing the content of each session in the form of videos, photos and audio recorded by the researcher, PowerPoint Educational, which provided fun and enjoyable moments for mothers. Life skills training sessions lasted 2 sessions per week and each session lasted 2 minutes.Pregnant women were taught life skills (self awareness, problem solving skills, stress control, emotion control, communication skills, and interpersonal relationships).Then, in the sixth session, the Vandenberg Pregnancy Anxiety Questionnaire was completed by the intervention group. Intervention 2: Control group: The control group completed Wendenberg Pregnancy Anxiety Questionnaires after 6 weeks without receiving any training and then ethically trained and given virtual training videos, relaxation exercise videos and songs for moral control. Calming and PowerPoint tutorials were provided in the form of a DVD.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Because of the confidentiality of the information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojgan Javad Noori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz University of Medical Sciences - School of Nursing and Midwifery</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3373 8395</telephone>
        <email>mojganjavadnoori@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Hassanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17th Shahrivar hospital</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6318913331</zip>
        <telephone>+98 61 5335 2505</telephone>
        <email>fatemehasanpoor50@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women over 30 years old
Pregnant women after the first trimester
Diagnosis of pregnancy anxiety based on Wendenberg questionnaire with pregnancy anxiety score between 160-280
Minimum literacy
Willingness to participate in the study and obtain written consent
Not receiving psychotherapy or other medication concurrently (at least one month before the study) for anxiety-related problems</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosed cases of mental disorders
Detection of a loved one's death in the last 6 months
A history of taking drugs that affect mental health</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The present quasi-experimental study consists of three parts: pre-test, intervention and post-test. When the initial questionnaires were completed by pregnant women.Based on the inclusion criteria, the intervention group was divided into 5 groups, each consisting of 3 to 4 persons, and for each group, life skills training was conducted separately by the researcher in a face-to-face workshop. In the life skills training sessions, the researcher first obtained information through question and answer, group discussion, brainstorming from mothers' knowledge and attitudes about those topics, and then through lecture methods and PowerPoint presentations to better understand her topics. The session was offered to pregnant mothers, and each training session was organized as a workshop with the participation of pregnant women.It should be noted that in order to make the training more effective and effective, and taking into account the specific circumstances of the pregnant women during the week, virtual training was provided in the WhatsApp groups.These tutorials included relaxation exercise videos, reviewing the content of each session in the form of videos, photos and audio recorded by the researcher, PowerPoint Educational, which provided fun and enjoyable moments for mothers. Life skills training sessions lasted 2 sessions per week and each session lasted 2 minutes.Pregnant women were taught life skills (self awareness, problem solving skills, stress control, emotion control, communication skills, and interpersonal relationships).Then, in the sixth session, the Vandenberg Pregnancy Anxiety Questionnaire was completed by the intervention group.</i_keyword>
      <i_keyword>Control group: The control group completed Wendenberg Pregnancy Anxiety Questionnaires after 6 weeks without receiving any training and then ethically trained and given virtual training videos, relaxation exercise videos and songs for moral control. Calming and PowerPoint tutorials were provided in the form of a DVD.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pregnancy anxiety score based on Vendenberg Pregnancy Anxiety Questionnaire PRAQ. Timepoint: Before intervention. Method of measurement: Pregnancy Anxiety Score from 160 to 280 from Vendenberg Pregnancy Anxiety 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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-13</approval_date>
        <contact_name>Ethics committee of Ahvaz  jundishapur University of Medical Sciences</contact_name>
        <contact_address>University City, Ahvaz Jundishapur University of Medical Sciences and Health Services Vice Chancellor for Research and Technology, ground floor- zip code: 15794-61357 Abadan Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
