<?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>IRCT20210528051421N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-29</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Emotional Disclosure on Depression, Anxiety and Stress and Quality of Life in Women after Abortion</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Emotional Disclosure on Depression, Anxiety and Stress and Quality of Life in Women after Abortion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56549</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method is a simple individual randomization that using random sequence generated by www.randomization.com, individuals in the group are divided into two groups of intervention and control.
In this way, the generated random sequence is written on small sheets and kept in a closed envelope, and when each person is selected, the envelope door is opened and she enters each group according to the code (A and B).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: depression. Condition 2: anxiety. Condition 3: stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: emotional disclosure. In this group, in addition to the usual medical care of the hospital, during an individual session, in an explanatory manner and face to face, emotional disclosure (written and spoken) is taught to women after spontaneous abortion. Then, they are asked to freely express their deepest negative feelings and emotions for  1 ±4 sessions, each time for 15-20 minutes for 2 consecutive weeks (2 ±1 sessions per week) in a secluded and completely quiet and comfortable place at home. And write fluently on reminder sheets. They are told to free their minds and focus entirely on the writing experience. When writing, do not worry about spelling words or structural rules of sentences and the spatial and temporal order of events, and continue writing until the end of time. At the end of each week, an oral disclosure session (two sessions in total) will be conducted by telephone with them for 15-20 minutes. Intervention 2: Control group: They receive medical education and care, including control of vital signs and vaginal bleeding until they stabilize after an abortion and receive medication.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maleknaz Ghannadkafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Nursing and Midwifery, Ibn-e Sina St., Chaharah Doktora Crossing, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>0098 51 3859 1511-3</telephone>
        <email>nkafi@bums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kobra Mirzakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Nursing and Midwifery, Ibn-e Sina St., Chaharah Doktora Crossing</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>0098 51 38591511-3</telephone>
        <email>Mirzakhanik@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1-Women who have had a miscarriage within 48-24 hours.
2- Will be willing to participate in the study and complete the informed consent form.
3- Be a Muslim and an Iranian.
4- To be 18-45 years old.
5- Pregnancy is the desire of the couple.
6- Does not have chronic physical diseases.
7 - Do not have a disability.
8- Has no other psychological disorders.
9- Be literate.
10- Do not have major stressful events in the last 6 months.
11- Has not taken sedatives and psychotropic drugs in the last 6 months.
12- Not addicted to drugs, tobacco and alcohol.
13- Have a spouse and live with his.
14- Has no history of infertility.
15- Depression score between 10-20 (mild and moderate depression) has been obtained from the Depression, Anxiety and Stress Questionnaire 21-DASS.
16- Anxiety score higher than 7 (mild anxiety up) has been obtained  from the Depression, Anxiety and Stress Questionnaire 21-DASS.
17- Stress score higher than 14 (mild stress upwards) has obtained  from the Depression, Anxiety and Stress Questionnaire 21-DASS.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unable to write, speak or listen.
Have severe physical complications from abortion.
Do not have access to a mobile phone.
Be pregnant with assisted reproductive techniques.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.0</hc_code>
      <hc_code>F41.1</hc_code>
      <hc_code>F43.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, mild</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
      <hc_keyword>Acute stress reaction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: emotional disclosure. In this group, in addition to the usual medical care of the hospital, during an individual session, in an explanatory manner and face to face, emotional disclosure (written and spoken) is taught to women after spontaneous abortion. Then, they are asked to freely express their deepest negative feelings and emotions for  1 ±4 sessions, each time for 15-20 minutes for 2 consecutive weeks (2 ±1 sessions per week) in a secluded and completely quiet and comfortable place at home. And write fluently on reminder sheets. They are told to free their minds and focus entirely on the writing experience. When writing, do not worry about spelling words or structural rules of sentences and the spatial and temporal order of events, and continue writing until the end of time. At the end of each week, an oral disclosure session (two sessions in total) will be conducted by telephone with them for 15-20 minutes.</i_keyword>
      <i_keyword>Control group: They receive medical education and care, including control of vital signs and vaginal bleeding until they stabilize after an abortion and receive medication.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in Anxiety, Stress, Depression Questionnaire (DASS -21). Timepoint: Before the intervention, end of the intervention and one month after the intervention. Method of measurement: Anxiety, stress, depression questionnaire ( DASS -21).</prim_outcome>
      <prim_outcome>Anxiety score in Anxiety, Stress, Depression Questionnaire (DASS -21). Timepoint: Before the intervention, end of the intervention and one month after the intervention. Method of measurement: Anxiety, stress, depression questionnaire ( DASS -21).</prim_outcome>
      <prim_outcome>Stress score in Anxiety, Stress, Depression Questionnaire (DASS -21). Timepoint: Before the intervention, end of the intervention and one month after the intervention. Method of measurement: Anxiety, stress, depression questionnaire ( DASS -21).</prim_outcome>
      <prim_outcome>Quality of life score in the World Health Organization quality of life questionnaire. Timepoint: Before the intervention, end of the intervention and one month after the intervention. Method of measurement: World Health Organization Quality of Life Questionnaire - Short Form.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-09</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences-School of Nursing and Midwifery</contact_name>
        <contact_address>Chaharah Doktora Crossing, Ibn-e Sina St, Mashhad Faculty of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
