<?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>IRCT20200630047968N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-05</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of resiliency training on mental health of pregnant women with unwanted pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of resiliency training on mental health of pregnant women with unwanted pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49362</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to prevent interaction and exchange of information between individuals in the two groups, three centers were assigned to each group by random allocation. Random allocation was done in such a way that the selected health centers (6 centers) were randomly divided into two groups (3 centers in each group). The names of the centers were written on a piece of paper and placed in a lottery bag. The first sheet that was randomly removed from the bag was assigned to the intervention group and the second sheet to the control group and continued until the end of the sheets, Blinding description: Outcome assessor and data analyser of the outcomes will be unaware of the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>unwanted pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, the general health questionnaire and the screening scale of Connor and Davidson will be completed. Educational topics include resilience training, first session: pre-test, unwanted pregnancy, resilience generalities, second session: self-acceptance, emotion control and anger management, recognizing strengths and weaknesses, third session: boosting self-esteem, communication and dating, Session 4: Determining purpose and purposeful life, Session 5: cultivating a sense of spirituality and faith, Session 6: providing a summary of all sessions. Immediately and one month after end of the educational intervention, the Resilience Scale and the General Health Questionnaire will be completed. Intervention 2: Control group: Control Group: First, the General Health Questionnaire and the Connor and Davidson Resilience Scale will be completed. The Control Group will receive only the routine pregnancy care.  Immediately and one month later, the Resilience Scale and the General Health Questionnaire will be completed.</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 results of this study will be provided to the library of the Faculty of Nursing and Midwifery of Mashhad for the use of students and research units as well as enthusiasts as the senior dissertation on midwifery. A copy of this study was also made available to relevant authorities upon request. Publication of the results in prestigious scientific and research journals will be done in compliance with the authors' rights in all publications resulting from this research project.

When:
Probably from the end of 1399

To whom:
Researchers, students and research units as well as other enthusiasts

Conditions:
The use of thesis in articles or any scientific article is subject to the mention of the source and in accordance with the publication regulations of Mashhad University of Medical Sciences.

Where to obtain:
Library of the School of Nursing and Midwifery of Mashhad

How to obtain:
Contact e-mail with supervisor and registered author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marjan Naderpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Crossroad of the Doktora, Khorasan Razavi, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9614765836</zip>
        <telephone>+98 51 4422 1656</telephone>
        <email>naderpourm1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Crossroad of the Doktora, Khorasan Razavi, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>moradim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women with unwanted pregnancies
Age 18 to 35 years
Mild and/or moderate problem of mental health based on the mental health questionnaire (score of 23 to 60 )
Low resilience based on the resilience scale (score less than 50)
Written consent form</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to diagnose abnormalities in the fetus (according to screening of the first or second trimester or anomaly scan of fetus
Lack of medical prohibition to maintain pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z64.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problems related to unwanted pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, the general health questionnaire and the screening scale of Connor and Davidson will be completed. Educational topics include resilience training, first session: pre-test, unwanted pregnancy, resilience generalities, second session: self-acceptance, emotion control and anger management, recognizing strengths and weaknesses, third session: boosting self-esteem, communication and dating, Session 4: Determining purpose and purposeful life, Session 5: cultivating a sense of spirituality and faith, Session 6: providing a summary of all sessions. Immediately and one month after end of the educational intervention, the Resilience Scale and the General Health Questionnaire will be completed.</i_keyword>
      <i_keyword>Control group: Control Group: First, the General Health Questionnaire and the Connor and Davidson Resilience Scale will be completed. The Control Group will receive only the routine pregnancy care.  Immediately and one month later, the Resilience Scale and the General Health Questionnaire will be completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mental health. Timepoint: The beginning of the study, immediately after the consultation sessions and one month after consultation sessions. Method of measurement: General Health Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Resilience. Timepoint: The beginning of the study, immediately after the consultation sessions and one month after consultation sessions. Method of measurement: Connor Davidson Resilience Scale.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-02</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی مشهد</contact_name>
        <contact_address>opposite to University Street 18, University Street, Mashhad University of Medical Sciences, Khorasan Razavi, Iran. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
