<?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>IRCT20250709066425N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-14</date_registration>
      <primary_sponsor>Azad University, South Tehran Branch</primary_sponsor>
      <public_title>The effectiveness of mindfulness self-compassion therapy on Mental Fatigue, Emotional Regulation, and Self-Critical Rumination</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Mindful Self-Compassion Therapy on Mental Fatigue, Emotion Regulation, and Self-Critical Rumination in Nurses with Job Burnout</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85377</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Experimental and control groups: After selecting the sample, in the next step, people are divided into experimental and control groups using a random method.
How to perform randomization: First step: After selecting the voluntary sample, all selected people are placed on a list (numbers from 1 to 30 are assigned to people). Second step: From these people, using a random method using sealed and opaque (numbered) envelopes, people are divided into two experimental groups and a control group. Each person randomly selects an envelope and is divided into the corresponding group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Burn-out.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 15 participants who meet the inclusion criteria and score at least 66 on the Maslach and Jackson 1981 Burnout Questionnaire will be randomly assigned to the control group. They will complete the Mental Fatigue, Emotion Regulation, and Self-Critical Rumination Questionnaire; however, no treatment will be administered to this group. Intervention 2: Intervention group: 15 participants who meet the inclusion criteria and score at least 66 on the Maslach and Jackson 1981 Burnout Questionnaire will be randomly assigned to the intervention group. They will complete the psychological fatigue, emotional regulation, and self-critical rumination questionnaires as a pre-test, then undergo 8 sessions of mindfulness-based self-compassion therapy based on the Neff and Grammer (2013) method, as well as 1 session of seclusion, each session lasting 165 minutes. After completing the sessions, they will complete the psychological fatigue, emotional regulation, and self-critical rumination questionnaires as a post-test.</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:
Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.

When:
Data can be made available 4 months after the results are published and after personally identifiable information is removed.

To whom:
The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions.

Conditions:
Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential.

Where to obtain:
f you need data, please contact maedesafdari7878@gmail.com

How to obtain:
After receiving and reviewing the request from the researcher, a response will be provided as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maede Safdari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, No. 33, Shahid Shahbazpour Alley, Najafzadeh Foroutan Street, Ayatollah Kashani Boulevard, 2nd Sadeghieh Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1471685811</zip>
        <telephone>+98 919 896 9762</telephone>
        <email>maedesafdari7878@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Salarirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr College, South Tehran Branch, Next to Bouali Hospital, Beginning of Damavand Street, Imam Hossein Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1936855875</zip>
        <telephone>009822801448</telephone>
        <email>salariradz@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obtaining a minimum score of 66 to diagnose burnout from the Maslach and Jackson (1981) questionnaire
Having the necessary criteria for diagnosing burnout according to (ICD-11) based on a structured interview with a clinical psychologist
Absence of diagnosable psychiatric disorders based on diagnostic criteria (DSM-5) and concurrent absence of acute physical illness
No concurrent chronic physical illnesses
Not receiving any other psychological treatment at the same time</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Nurses with less than one year of work experience</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z73.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn-out</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 15 participants who meet the inclusion criteria and score at least 66 on the Maslach and Jackson 1981 Burnout Questionnaire will be randomly assigned to the control group. They will complete the Mental Fatigue, Emotion Regulation, and Self-Critical Rumination Questionnaire; however, no treatment will be administered to this group.</i_keyword>
      <i_keyword>Intervention group: 15 participants who meet the inclusion criteria and score at least 66 on the Maslach and Jackson 1981 Burnout Questionnaire will be randomly assigned to the intervention group. They will complete the psychological fatigue, emotional regulation, and self-critical rumination questionnaires as a pre-test, then undergo 8 sessions of mindfulness-based self-compassion therapy based on the Neff and Grammer (2013) method, as well as 1 session of seclusion, each session lasting 165 minutes. After completing the sessions, they will complete the psychological fatigue, emotional regulation, and self-critical rumination questionnaires as a post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mental Fatigue. Timepoint: Pre-intervention and Post-intervention. Method of measurement: Mental Fatigue Questionnaire Johnson et al. 2010.</prim_outcome>
      <prim_outcome>Emotion Regulation. Timepoint: Pre-intervention and Post-intervention. Method of measurement: Emotion Regulation Questionnaire Cross and John 2003.</prim_outcome>
      <prim_outcome>Self-Critical Rumination. Timepoint: Pre-intervention and Post-intervention. Method of measurement: Self-Critical Rumination Questionnaire Smart et al. 2016.</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>Azad University, South Tehran Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-06-10</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University - Varamin-Pishva Branch</contact_name>
        <contact_address>Islamic Azad University, Varamin–Pishva Branch, Naghsh-e Jahan Town, Pishva County, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
