<?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>IRCT20231129060224N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-05</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The impact of neonatal palliative care training on the performance of neonatal intensive care unit nurses</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the impact of neonatal palliative care training on the performance of neonatal intensive care unit nurses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74124</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: All the nurses working in the neonatal intensive care unit of Shahid Sadoughi and Afshar hospitals will be allocated to groups using the Random Generator software, which is a random allocation software, and the qualified nurses will be equally placed in the intervention and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Palliative care.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: a suitable schedule will be created for nurses to implement the nurse training program. which will include: date, place, subject, time and duration of each meeting. The educational program will include two parts, the theoretical part (definition of palliative care, benefits, principles, reasons, philosophy and the role of the nurse in relation to palliative care and...) and practical parts (the role of nursing related to pain control, comfort measures, symptom management, ventilation) It will cover treatment, oxygen therapy, nutrition and family support.And before the training, the performance of the nurses in the morning and evening shifts will be observed for 15-20 minutes and scored using the performance checklist by the assistant researcher. Then these sessions will be held in the study environment. The group will be trained in theoretical and practical sessions. And a copy of the training program will be given to each nurse, and after the training, the performance score of the nurses will be measured two weeks and four weeks later and will be compared with the control group. Intervention 2: Control group: In the control group, no training will be given to nurses; And their performance score regarding the palliative care of newborns will be measured and graded using a checklist and will be compared with the intervention group.</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:
All data can potentially be shared after de-identifying individuals.

When:
The access period starts 6 months after the results are published.

To whom:
Researchers working in academic and scientific institutions

Conditions:
Access to data is possible by observing research ethics and referencing.

Where to obtain:
Mrs. Khadijah Dehghani/ Yazd University of Medical Sciences/ dehghanish@ssu.ac.ir/ 09131535531

How to obtain:
One Month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khadijeh Dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bo Ali St., Shahid Sadoughi College of Nursing and Midwifery, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۵۸۸۷۸۵۷</zip>
        <telephone>+98 35 3724 0171</telephone>
        <email>info@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khadijeh  Dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahnar Square</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915887857</zip>
        <telephone>+98 35 3724 0171</telephone>
        <email>info@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Work experience of at least 6 months in the special department for newborns with a nursing degree and above
Consent to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Previous history of participating in palliative care training</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z51.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for palliative care</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: a suitable schedule will be created for nurses to implement the nurse training program. which will include: date, place, subject, time and duration of each meeting. The educational program will include two parts, the theoretical part (definition of palliative care, benefits, principles, reasons, philosophy and the role of the nurse in relation to palliative care and...) and practical parts (the role of nursing related to pain control, comfort measures, symptom management, ventilation) It will cover treatment, oxygen therapy, nutrition and family support.And before the training, the performance of the nurses in the morning and evening shifts will be observed for 15-20 minutes and scored using the performance checklist by the assistant researcher. Then these sessions will be held in the study environment. The group will be trained in theoretical and practical sessions. And a copy of the training program will be given to each nurse, and after the training, the performance score of the nurses will be measured two weeks and four weeks later and will be compared with the control group.</i_keyword>
      <i_keyword>Control group: In the control group, no training will be given to nurses; And their performance score regarding the palliative care of newborns will be measured and graded using a checklist and will be compared with the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Performance of nurses in neonatal palliative care. Timepoint: Examining the performance of nurses regarding palliative care before the intervention and 14 and 21 days after the training workshop. Method of measurement: Assessing nurses performance using the nurses performance checklist in palliative care.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-04</approval_date>
        <contact_name>Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Bahonar square yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
