<?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>IRCT20211118053093N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-31</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Mindful Self compassion training in Infertile Women Undergoing IVF</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Mindful Self compassion training to Symptoms of Psychopathology and Increased Life expectancy in Infertile Women Undergoing  IVF</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64934</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants do not know which group they are in. The data analyser does not know which group it is analysing. The number of people in the intervention and treatment groups is the same (we have 15 patients in each group for the treatment group). The duration for both intervention and control groups is 8 sessions and each session is 90 minutes.The number of sessions is equal, so the patient is blind to the type of treatment.Data analysis is given only data and does not know what treatment was done for either group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility in females.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:This group is consist of 15 patients.Eight sessions of MSC therapy will be performed, each session lasting for90 minutes. The intervention will be performed according to a practical guide adapted from Neff’s protocol  and modified for group use.Necessary feedback will be provided and patients will be asked to actively attend and comment on the sessions and discuss their experiences related to the topic of each session. Also, at the end of each session, the contents of that session were summarized.Pre test is consist of (SCL-90-R) and Snyder’s Hope Questionnaire and is done before the start of the first session and at the end of the last session.                                                                                                       Session 1:Group members will get to know the goals of the treatment program and each other. They will be taught the meanings of concepts such as self-compassion, mindfulness, self-kindness, common human experience.                                                                                                               Session 2 :Attention will be introduced theoretically and practically, and how the mind can naturally, when at rest, look for problems in the past or future.                                                                                                                      Session 3:People  learn to love and be kind.                                                           Session 4:The main goal is to practice kind phrases with their own compassion dimension, and distinguish self-compassion from the inner critic.                                                                                                                      Session 5:The goal is to discover the core values ​​that give meaning to our lives.                                                                                                                            Session 6:People are taught how to label a difficult emotion and then express the emotion as a bodily sensation.                                                                     Session 7:People are taught to use compassionate expressions to endure the pain of problematic relationships.                                                                   Session 8: It is said that the human mind has a negative bias. Examining physical threats or emotional integrity can be useful for survival. Intervention 2: Control group: This group is consist of 15 patients.uring eight 90-minute sessions, people are talked about the IVF method.Pre test is consist of (SCL-90-R) and Snyder’s Hope Questionnaire and is done before the start of the first session and at the end of the last session.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Razeghian Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometer 13 of Shiraz-Isfahan highway, Ostad Mohrhari Hospital</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71441-13331</zip>
        <telephone>+98 71 3260 5701</telephone>
        <email>leilarazeghian1366@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Razeghian Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometer 13 of Shiraz-Isfahan highway, Ostad Mohrhari Hospital</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71441-13331</zip>
        <telephone>+98 71 3260 5701</telephone>
        <email>leilarazeghian1366@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum education at diploma level
one year has passed since the definite diagnosis of infertility
Not suffering from debilitating chronic physical diseases
Absence of psychiatric disorders</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having two absentee sessions
Getting any kind of disease while doing the research
Participating in an educational or other therapeutic workshop
Not wanting to continue cooperation during meetings</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility, unspecified N97.9</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:This group is consist of 15 patients.Eight sessions of MSC therapy will be performed, each session lasting for90 minutes. The intervention will be performed according to a practical guide adapted from Neff’s protocol  and modified for group use.Necessary feedback will be provided and patients will be asked to actively attend and comment on the sessions and discuss their experiences related to the topic of each session. Also, at the end of each session, the contents of that session were summarized.Pre test is consist of (SCL-90-R) and Snyder’s Hope Questionnaire and is done before the start of the first session and at the end of the last session.                                                                                                       Session 1:Group members will get to know the goals of the treatment program and each other. They will be taught the meanings of concepts such as self-compassion, mindfulness, self-kindness, common human experience.                                                                                                               Session 2 :Attention will be introduced theoretically and practically, and how the mind can naturally, when at rest, look for problems in the past or future.                                                                                                                      Session 3:People  learn to love and be kind.                                                           Session 4:The main goal is to practice kind phrases with their own compassion dimension, and distinguish self-compassion from the inner critic.                                                                                                                      Session 5:The goal is to discover the core values ​​that give meaning to our lives.                                                                                                                            Session 6:People are taught how to label a difficult emotion and then express the emotion as a bodily sensation.                                                                     Session 7:People are taught to use compassionate expressions to endure the pain of problematic relationships.                                                                   Session 8: It is said that the human mind has a negative bias. Examining physical threats or emotional integrity can be useful for survival.</i_keyword>
      <i_keyword>Control group: This group is consist of 15 patients.uring eight 90-minute sessions, people are talked about the IVF method.Pre test is consist of (SCL-90-R) and Snyder’s Hope Questionnaire and is done before the start of the first session and at the end of the last session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychopathology score. Timepoint: Before starting the study and after completing the study. Method of measurement: Revised scale of the 90 symptom inventory                                                                     It is a common self-report instrument for measuring psychopathology. The 90 items of this scale describe the symptoms that psychiatric patients experience and report.</prim_outcome>
      <prim_outcome>Amount of hope. Timepoint: Before starting the study and after completing the study. Method of measurement: hope  questionnaire of  Schneider                                                                                        The 12-factor hope scale is designed for ages 15 and up. You get the person's general hope score, which ranges from 8 to 32.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-02</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Kilometer 13 of Shiraz-Isfahan highway, Ostad Mohrhari Hospital Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
