<?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>IRCT20200111046079N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-09</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of  Leadership and Mentorship Program in Clinical Midwifery Education</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Leadership and Mentorship Program in Clinical Education of Midwifery Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67124</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to generate the random sequence, simple randomization will be used in such a way that by using a table of random numbers based on the list of names and student numbers of final year midwifery students, people will be randomly placed in two groups A and B. The table of random numbers used in this research will include numbers that will be placed next to each other in rows and columns in the form of five-digit blocks and separately. To use this table, we will assign two-digit codes corresponding to the last two numbers of the student number, such as 01, 02,..., 29, 30, according to the exact size of the sample (30 students). Then the researcher will randomly start from a point to select sample people from the table. For this purpose, the researcher will choose the starting point by closing his eyes and placing the tip of the pen on the table, then she will move in the direction of the row or column until numbers choose the one whose last two digits (i.e. the two digits on the right side of each block of five) are smaller than the sample size (which actually corresponds to the student number of the sample). This process will continue until the sample volume is completed. The first 15 selected codes will belong to group A and the next 15 codes will belong to group B. It should be noted that the nature of two groups A and B is not known in advance.  Next to randomly assign the two research groups as well as to concealment random allocation according to the same groups A and B, and according to the corresponding codes in sequentially numbered, opaque, sealed envelopes, by an out -of -study person with no information There is no research goals.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Clinical midwifery education.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the control group, in the first two months of the beginning of the semester, the internship program of the maternity hospital will be implemented according to the usual routine in the previous semesters based on the program presented by the director of the midwifery department,.The clinical instructors, according to their usual training method that they used to train students The clinical training of the students will take place in the maternity hospital, and it is very clear that the interventions related to the mentorship program will not be implemented in the control group. Finally, the evaluation of the clinical competence of the students in the control group will be carried out by the trainers based on the trainer's personal opinion as usual. We need to mention that since the communication of students with each other in the places of the university, dormitory, hospital, etc. could have an effect on the results of the research, therefore, after random allocation, the group that is selected first during random concealment will be selected automatically. They will enter the control group and in the first two months of the study, the control group will start and the next group will enter the study as the intervention group in the next two months. Intervention 2: Intervention group: In the intervention group, in the next two months of the semester, the internship program of the maternity hospital will be implemented based on the mentorship training method, and the clinical trainers will train the students after passing the clinical training workshops. It should be noted that the items related to the mentorship program will be determined after reviewing the texts and the Delphi technique. Finally, the evaluation of the mentorship program will be done using the Kirk patrick evaluation model.</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 and results of the research will be provided to Jundishapur University of Medical Sciences Ahvaz and Sina and Taleghani Hospitals

When:
It will be possible to access the research documents six months after the final statistical analysis and the end of the qualitative phase of the study.

To whom:
The data will be available only for the use of researchers of academic institutions.

Conditions:
In order to develop research in the field of clinical education of medical sciences and mentorship

Where to obtain:
In order to receive the data, people can refer to the main executive of the project, Dr. Mina Irvani, a member of the academic staff of Jundishapur University of Medical Sciences, Ahvaz.

How to obtain:
After obtaining the necessary permits from the Jundi Shapur University of Medical Sciences and the Vice-Chancellor of Research and Technology of this university, the applicant can proceed to receive the documents.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Iravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>157915794</zip>
        <telephone>+98 61 3311 0000</telephone>
        <email>iravani-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Iravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>157915794</zip>
        <telephone>+98 61 3311 0000</telephone>
        <email>iravani-m@ajums.ac</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for midwifery students: final year midwifery students who want to participate in the study.
Inclusion criteria  for midwifery trainers: trainers who want to mentoring and educate students.
Having a minimum Midwifery Masters Degree
Having at least five years of work experience in the maternity unit
Inclusion criteria for Service Recipients: low -risk pregnant women are hospitalized in maternity for delivery.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Guest students, that is, students studying at other universities who have been guest at Jundishapur University for one semester
Coaches outside the staff of Jundishapur University of Medical Sciences
High-risk pregnancy and labor of child-bearing women</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In the control group, in the first two months of the beginning of the semester, the internship program of the maternity hospital will be implemented according to the usual routine in the previous semesters based on the program presented by the director of the midwifery department,.The clinical instructors, according to their usual training method that they used to train students The clinical training of the students will take place in the maternity hospital, and it is very clear that the interventions related to the mentorship program will not be implemented in the control group. Finally, the evaluation of the clinical competence of the students in the control group will be carried out by the trainers based on the trainer's personal opinion as usual. We need to mention that since the communication of students with each other in the places of the university, dormitory, hospital, etc. could have an effect on the results of the research, therefore, after random allocation, the group that is selected first during random concealment will be selected automatically. They will enter the control group and in the first two months of the study, the control group will start and the next group will enter the study as the intervention group in the next two months.</i_keyword>
      <i_keyword>Intervention group: In the intervention group, in the next two months of the semester, the internship program of the maternity hospital will be implemented based on the mentorship training method, and the clinical trainers will train the students after passing the clinical training workshops. It should be noted that the items related to the mentorship program will be determined after reviewing the texts and the Delphi technique. Finally, the evaluation of the mentorship program will be done using the Kirk patrick evaluation model.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Midwifery student's clinical competency. Timepoint: After the end of the semester and at the time of the Midwifery Final Test. Method of measurement: Clinical Competence Questionnaire.</prim_outcome>
      <prim_outcome>Midwifery students' satisfaction. Timepoint: After the end of the semester and at the time of the Midwifery Final Test. Method of measurement: Satisfaction Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Type of delivery. Timepoint: After the end of the semester. Method of measurement: Using the Bureau of Delivery.</sec_outcome>
      <sec_outcome>Perineal status. Timepoint: After the delivery. Method of measurement: Due to the intensity of the perineal area rupture as grade 1,2,3,4.</sec_outcome>
      <sec_outcome>Post partum hemmorage. Timepoint: Eight hours after delivery. Method of measurement: Measurement of hematocrit level.</sec_outcome>
      <sec_outcome>Apgar score. Timepoint: One minute after delivery and five minutes after delivery. Method of measurement: Based on clinical evaluation and examination of skin color, muscle tone, crying, heart rate, response to catheter stimulation.</sec_outcome>
      <sec_outcome>Breastfeeding. Timepoint: The first hour after childbirth. Method of measurement: Breastfeeding or not?.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-23</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Esfand Ave., Golestan Blvd.,Deputy of research and technology, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
