<?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>IRCT20260622069909N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-12</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of an ethical intervention on the perception of futile care and moral distress in nurses.</public_title>
      <acronym>MCD</acronym>
      <scientific_title>Determinate the effect of Moral Case Deliberation on understanding futile care and moral distress in nurses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91113</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Education/Guidance, Randomization description: In this study, a clustered permuted-block method will be used to generate the random allocation sequence for assigning ICU centers to the study groups. The random allocation sequence for individuals will be generated using Random Allocation Software with random block sizes. Sealed envelopes will be used for allocation concealment, Blinding description: Study units will be selected using a convenience sampling method based on inclusion and exclusion criteria.
A total of eight ICU units from two hospitals will be included in the study, with four units selected from each hospital via convenience sampling. Within each hospital, two ICU units will be assigned to the intervention group and two to the control group. Randomization of the ICU units within each hospital will be conducted separately using permuted blocks. The random allocation sequence will be generated using "Random Allocation Software" with random block sizes.To ensure allocation concealment, the allocation sequence will be placed in opaque, sealed, and numbered envelopes, such that those administering the intervention remain unaware of the group assigned to the ICU sections until the intervention is actually performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Understanding futile care. Condition 2: Moral distress.</hc_freetext>
      <i_freetext>Intervention 1: MCD will be implemented in the intervention group. Prior to the intervention, to ensure consistency across groups regarding the ethical cases presented, the research team will compile a list of ethical scenarios—such as end-of-life care and patients in a vegetative state—tailored to the ICU setting and the study objectives; these scenarios will be reviewed and validated by experts. Subsequently, one ethical scenario will be selected for presentation during each MCD session. Based on prior research, the MCD intervention will be conducted over three sessions, spaced one week apart. The sessions will be held with groups of ten nurses.The sessions will be structured such that the first session is held in person, while the second and third sessions take place virtually (via the Skyroom platform). Based on prior research, the duration of each in-person session will be between one and one-and-a-half hours. The MCD team will consist of a coordinator and two facilitators with expertise in nursing ethics concepts. Drawing on previous studies, the MCD intervention will be implemented across ten stages during each session. Intervention 2: Control group: For the control group, educational content regarding ethical considerations in intensive care will be provided. Prior to the intervention, this content will be developed based on an extensive review of relevant literature and consultation with specialists and experts; it will then be submitted to seven faculty members and specialists for review and feedback on its quality. Subsequently, the resulting suggestions will be evaluated and incorporated.</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 further information"</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Raoufi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Shahid Dr. Kharazmi Complex, Mashhad University of Medical Sciences, opposite Mellat Park, Vakil-Abad Highway, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177949025</zip>
        <telephone>+98 51 3884 6730</telephone>
        <email>Raoufie4031@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nayereh Davoudi Hasan Abad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Shahid Dr. Kharazmi Complex, Mashhad University of Medical Sciences, opposite Mellat Park, Vakil-Abad Highway, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177949025</zip>
        <telephone>+98 51 3884 6730</telephone>
        <email>DavoudiN@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having consent to participate in the study
At least six months of work experience in an intensive care unit.
Working in the intensive care unit at the time of the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue participating in the research
Failure to attend at least one MCD meeting</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>MCD will be implemented in the intervention group. Prior to the intervention, to ensure consistency across groups regarding the ethical cases presented, the research team will compile a list of ethical scenarios—such as end-of-life care and patients in a vegetative state—tailored to the ICU setting and the study objectives; these scenarios will be reviewed and validated by experts. Subsequently, one ethical scenario will be selected for presentation during each MCD session. Based on prior research, the MCD intervention will be conducted over three sessions, spaced one week apart. The sessions will be held with groups of ten nurses.The sessions will be structured such that the first session is held in person, while the second and third sessions take place virtually (via the Skyroom platform). Based on prior research, the duration of each in-person session will be between one and one-and-a-half hours. The MCD team will consist of a coordinator and two facilitators with expertise in nursing ethics concepts. Drawing on previous studies, the MCD intervention will be implemented across ten stages during each session.</i_keyword>
      <i_keyword>Control group: For the control group, educational content regarding ethical considerations in intensive care will be provided. Prior to the intervention, this content will be developed based on an extensive review of relevant literature and consultation with specialists and experts; it will then be submitted to seven faculty members and specialists for review and feedback on its quality. Subsequently, the resulting suggestions will be evaluated and incorporated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score derived from Mohammadi's Futile Care Perception Questionnaire. Timepoint: Before the intervention, immediately, and two weeks after the end of the last MCD session. Method of measurement: Mohammadi's perception of futile care questionnaire.</prim_outcome>
      <prim_outcome>The score derived from the Soleimani Moral Distress Questionnaire. Timepoint: Before the intervention, immediately, and two weeks after the end of the last MCD session. Method of measurement: Soleimani's 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-17</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing, Shahid Dr. Kharazmi Complex, Mashhad University of Medical Sciences, opposite Mellat Park, Vakil-Abad Highway, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
