<?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>IRCT20251028067796N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of mindfulness exercises on moral distress</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mindfulness exercises on moral distress among nurses working in the intensive care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87113</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: After preparing the list of eligible nurses and assigning a unique number to each individual, the randomization process was carried out using a random number table. A starting point in the table was first selected at random. Then, the numbers in the table were read sequentially, and each number was assigned to one of the two groups based on whether it was even or odd; even numbers were allocated to the control group and odd numbers to the intervention group. Numbers that fell outside the range of assigned codes were ignored, and the reading continued until the required sample size was achieved.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Moral distress among nurses working in the intensive care units.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, the demographic questionnaire and Hamric’s Moral Distress Questionnaire will be completed for the intervention group. Then, the intervention will be implemented as an in-service training program titled “Mindfulness Exercises Training,” consisting of 7 to 8 in-person sessions of 60 minutes each (using PowerPoint presentations). The session content includes mindfulness exercises based on Jon Kabat-Zinn’s model (mindful breathing, body scan, sitting meditation, mindful movement, awareness of the present moment in daily activities, acceptance, and non-judgment). After completing the sessions, the Moral Distress Questionnaire will be administered again to the intervention group, and the results of the intervention and control groups will be compared and evaluated. Intervention 2: Control group: First, the demographic questionnaire and Hamric’s Moral Distress Questionnaire will be completed for the control group. After the intervention is completed, the educational content provided to the intervention group will also be presented to the control group in order to observe ethical considerations and allow these participants to benefit from the in-service training program as well.</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 No additional information is available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>hamidreza ghavami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd, Safaieh, Alam Square, Islamic Azad University Complex</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915813135</zip>
        <telephone>+98 35 3821 6781</telephone>
        <email>hamid.r.gh.1998@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Masoumeh Barkhordari Sharif Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd, Safaieh, Alam Square, Shohada-ye Gomnam Boulevard, Islamic Azad University Complex</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915813135</zip>
        <telephone>+98 35 3821 6781</telephone>
        <email>barkhordary_m@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a bachelor's degree or higher
Ability to attend all meetings
Having at least 6 months of work experience in the intensive care unit (ICU)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Simultaneous participation in an intervention program during the implementation of the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: First, the demographic questionnaire and Hamric’s Moral Distress Questionnaire will be completed for the intervention group. Then, the intervention will be implemented as an in-service training program titled “Mindfulness Exercises Training,” consisting of 7 to 8 in-person sessions of 60 minutes each (using PowerPoint presentations). The session content includes mindfulness exercises based on Jon Kabat-Zinn’s model (mindful breathing, body scan, sitting meditation, mindful movement, awareness of the present moment in daily activities, acceptance, and non-judgment). After completing the sessions, the Moral Distress Questionnaire will be administered again to the intervention group, and the results of the intervention and control groups will be compared and evaluated.</i_keyword>
      <i_keyword>Control group: First, the demographic questionnaire and Hamric’s Moral Distress Questionnaire will be completed for the control group. After the intervention is completed, the educational content provided to the intervention group will also be presented to the control group in order to observe ethical considerations and allow these participants to benefit from the in-service training program as well.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The moral distress score in the Hamric questionnaire. Timepoint: Before the intervention and immediately after the completion of the intervention sessions. Method of measurement: Hamric Moral Distress Questionnaire.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-09-07</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Isfahan (Khorasgan) Branch</contact_name>
        <contact_address>Islamic Azad University, Isfahan (Khorasgan) Branch, Daneshgah Boulevard, Arghavaniyeh, East J Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
