<?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>IRCT20220822055777N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-06</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>effect of technique emotionol relesse in women with recurrently miscarriage</public_title>
      <acronym></acronym>
      <scientific_title>The effect of  performing technique emotionol relesse on stress, anxiety and depression in women with recurrently miscarriage</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is such that the participants were assigned to two control and intervention groups using the www.random.org site and through random block design with a block size of 4. Blocking was done by a person not involved in data sampling and analysis. The person is asked to write any number of 4-digit letters from the letters A and B, for example, AAAA, BBBB, etc. Then the researcher numbers these letters. The random site is used to assign random numbers. The output of this site is numbers. In order to hide the allocation, the type of intervention will be written on a sheet of paper and placed inside opaque envelopes numbered consecutively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>recurrently miscarriage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, in this research, a pre-test will be taken from both the test and control groups, and after that, the experimental group will be trained in mind release techniques for 8 sessions, one two-hour session every week, and this method will be taught by the therapist. Individual subjects are executed. Training and implementation of the IFT technique will be done using Craig's instructions (2017) under the title "Golden Standard of IFT". Intervention 2: Control group:they will take a pre-test at the beginning of the study. During the study and implementation of the intervention, they will not receive any training and after 4 weeks the post-test will take place. At the end of the study, after obtaining the results, during a 2-hour session for The control group is briefly explained about the technique of freeing the mind and its effects based on the obtained results.</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 obtained from the research will be reflected to the University of Medical Sciences and the Vice-Chancellor of Health

When:
After printing the results

To whom:
Deputy health and research

Conditions:
In order to be used in various educational, clinical, research and economic fields.

Where to obtain:
Name: Masoomeh Kheirkhah
Email: kheirkhah.m@iums.ac.ir
Name: Rana Moozafari
Email: raanamoozafari@gmail.com

How to obtain:
Contact the corresponding author by email and register the request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoomeh Kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۷۱۳۸۸۳</zip>
        <telephone>+98 21 4365 1707</telephone>
        <email>kheirkhah.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoomeh Kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۷۱۳۸۸۳</zip>
        <telephone>002143651707</telephone>
        <email>kheirkhah.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Reading and writing skills
Having multiple sexual partners
Recurrence of miscarriages in the early stages of pregnancy (more than two miscarriages)</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>From 6 months before the study to the end of the study,  medicinal or non-medicinal methods were used to boost stress, anxiety or depression.
In the last 3 months, the couple has experienced any stressful experiences, such as the death of a loved one
The couple does  suffer from mental illness
having attended a mind liberation class in the past
suffering from severe stress, anxiety, or depression
At the time of entering the study, the attending physician diagnosed  inflammation or pelvic masses.
tobacco abuse by the spouse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spontaneous abortion</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: In the intervention group, in this research, a pre-test will be taken from both the test and control groups, and after that, the experimental group will be trained in mind release techniques for 8 sessions, one two-hour session every week, and this method will be taught by the therapist. Individual subjects are executed. Training and implementation of the IFT technique will be done using Craig's instructions (2017) under the title "Golden Standard of IFT".</i_keyword>
      <i_keyword>Control group:they will take a pre-test at the beginning of the study. During the study and implementation of the intervention, they will not receive any training and after 4 weeks the post-test will take place. At the end of the study, after obtaining the results, during a 2-hour session for The control group is briefly explained about the technique of freeing the mind and its effects based on the obtained results.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: 4 weeks after the educational intervention. Method of measurement: Stress, anxiety and depression questionnaire (DASS-21).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: 4 weeks after the educational intervention. Method of measurement: Stress, anxiety and depression questionnaire (DASS-21).</prim_outcome>
      <prim_outcome>Depression. Timepoint: 4 weeks after the educational intervention. Method of measurement: Stress, anxiety and depression questionnaire (DASS-21).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-23</approval_date>
        <contact_name>Research Ethics Committees of Iran University of Medical Sciences</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
