<?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>IRCT20191125045491N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-06</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>Studying The effect of communication skills training on moral distress</public_title>
      <acronym></acronym>
      <scientific_title>Studying The effect of communication skills training on nurses' moral distress</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2641-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/43761</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: 50 nurses will be selected randomly by computer software, and randomly assigned code 1 in the control group and code 2 in the intervention group by computer .</study_design>
      <phase>N/A</phase>
      <hc_freetext>medical ethics.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: first, the moral distress questionnaire will be completed individually before the intervention, and then for this group, communication skills training will be conducted in 4 two-hour sessions in one month based on the educational content chapter extracted from other articles and The scientific literatures as follows: during the first session   we will focus on basic concepts of communication, factors affecting communication, and effective communication skills of nurses with other members of the medical team (including physician, nurse, service personnel, etc.), Patients and their families. in the second session: transferring medical information  and necessary required actions to the physician and other medical team members, effective feedback, communicating with patients with special needs and transferring medical information, disease prognosis and different treatment methods to the patients and their families will be discussed, in the third session we will focus on communication barriers, anger control skills, Rejection skills and how to deal with the aggressive patient and family. and finally in the last session we will focus on ethics in communicating and the exchange of different point of views and expert scientific  opinions. then Nurses' moral distress will be measured one month after the intervention. Intervention 2: Control group: first, the moral distress questionnaire will be completed individually, then again two months later the moral distress questionnaire will be completed by this group. After completing the research and following the ethics of research in case of positive effect of communication skills on nurses' moral distress in intervention group, communication skills training sessions will be conducted for control group too.</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 for ethical reasons</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mohammad sobhanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>jahrom, enghelab ave, resalat street</address>
        <city>jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7419744379</zip>
        <telephone>+98 71 5444 0769</telephone>
        <email>sobhanianmohamad@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mohammad sobhanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>jahrom, enghelab ave, resalat street</address>
        <city>jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7419744379</zip>
        <telephone>+98 71 5444 0769</telephone>
        <email>sobhanianmohamad@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Nurses' consent to participate in the study
At least one year of working experience
No illness or use of psychotropic drugs
Failure to participate in other interventional studies with ethical or communication issues at the same time
Having moderate to high moral distress in the initial assessment of hospital staff's moral distress</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Mental illness that can disrupt educational and communication processes during the study
Absence of more than two sessions in communication skills training workshops
Attend communication skills training workshops in the past 6 months
Nurses working in CCU wards, neonatal intensive care unit, dialysis, supervising office and eye surgery at the time of the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>moral dist</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>training , Communication skills, moral distress,  nursing</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: first, the moral distress questionnaire will be completed individually before the intervention, and then for this group, communication skills training will be conducted in 4 two-hour sessions in one month based on the educational content chapter extracted from other articles and The scientific literatures as follows: during the first session   we will focus on basic concepts of communication, factors affecting communication, and effective communication skills of nurses with other members of the medical team (including physician, nurse, service personnel, etc.), Patients and their families. in the second session: transferring medical information  and necessary required actions to the physician and other medical team members, effective feedback, communicating with patients with special needs and transferring medical information, disease prognosis and different treatment methods to the patients and their families will be discussed, in the third session we will focus on communication barriers, anger control skills, Rejection skills and how to deal with the aggressive patient and family. and finally in the last session we will focus on ethics in communicating and the exchange of different point of views and expert scientific  opinions. then Nurses' moral distress will be measured one month after the intervention.</i_keyword>
      <i_keyword>Control group: first, the moral distress questionnaire will be completed individually, then again two months later the moral distress questionnaire will be completed by this group. After completing the research and following the ethics of research in case of positive effect of communication skills on nurses' moral distress in intervention group, communication skills training sessions will be conducted for control group too.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average of moral distress score. Timepoint: before intervention and 1 month after intervention. Method of measurement: Hamric's moral Distress Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Not contained. Timepoint: not contained. Method of measurement: not contained.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-31</approval_date>
        <contact_name>Ethics committee of Jahrom University of Medical Sciences</contact_name>
        <contact_address>jahrom, motahari ave, Jahrom University of Medical Sciences jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
