<?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>IRCT20230626058593N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-07</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Balint group work on empathy and job burnout</public_title>
      <acronym></acronym>
      <scientific_title>Determining and comparing the effect of Balint group work on job burnout and empathy with patient in the nurses of the oncology department of Shahid Sadoughi Hospital in Yazd with the control group</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70992</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants are placed in one of the intervention and control groups using the permutation block randomization method.
The selection of samples using the method of randomization of samples is based on the form of alternating blocks. Given that the total number of samples is 28, 7 blocks of size 4 will be considered and the blocks will be selected randomly. and then according to each block that contains 4 samples, the samples will be randomly assigned to one of the two intervention or control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Examining job burnout and empathy with patients on nurses..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Balint Group .Balint group is a group intervention for the staff working in the medical science system. This intervention was designed and implemented by Professor Balint in 1957 and has been implemented around the world since then. The method of this intervention is in the form of a group in such a way that 12-14 members of the medical staff who have been selected homogeneously (have the same job) come together for 60 minutes with the presence of two group leaders in a group structure. The arrangement of the group is in the form of a ring. First, for 10 minutes, under the guidance of the leader and chosen by the group members, one person talks about his emotional experience in the work environment, especially in relation to the patient, then that person is removed from the group for 35 minutes.(The person stays in the group space and outside the circle.) And the rest of the group members talk about this person's emotional experience in an empathetic way, focusing on their own experiences. The leader directs the atmosphere of the group in order to better understanding the expressed experience and regulate people's emotions and empathy and performs the necessary interventions to reduce the emotional burden of the topic of discussion. Then, in the last 15 minutes, the first person enters the group and expresses his feelings and experience from listening to the talks of others and the group leaders, and the group leader analyzes the psychodynamic components of the relationship with the patient. Intervention 2: Control group: Psychoeducation group: For this group, 6 sessions of psychoeducation will be held in such a way that each session will last for 60 minutes. The people of this group will be trained in psychological issues related to grief in the form of attending a training class. Sessions include: The first session talks about the definition of grief. The second session is about types of mourning. The third session is about the stages of mourning from the perspective of Kubler-Ross. The fourth session is about therapeutic and psychological interventions in bereavement. The fifth session is about stress control. The sixth session will be about emotion regulation.</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:
Information about the data that is related to the conclusion is published.

When:
After the study is completed and the result of the study is determined, it will be available

To whom:
All people interested in studying

Conditions:
The use of data is allowed under the condition of compliance with ethics.

Where to obtain:
Dr shirkhoda
shshirkhoda@gmail.com

How to obtain:
The request should be submitted and the answer will be given after seeing the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Shahabali Shirkhoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatric Center of Yazd, Shahid Beheshti Blvd., Taft</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8991683316</zip>
        <telephone>009832632003</telephone>
        <email>shshirkhoda@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Shahabali Shirkhoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatric Center of Yazd, Shahid Beheshti Blvd., Taft</address>
        <city>Taft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8991683316</zip>
        <telephone>+98 35 3263 2003</telephone>
        <email>shshirkhoda@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Working in the oncology department
Consent to participate in the study
Work experience less than 20 years</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having an active addiction to drugs or alcohol
Suffering from chronic physical disorders
Having psychotic disorders
The presence of psychological or drug interventions at the moment</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>Intervention group: Balint Group .Balint group is a group intervention for the staff working in the medical science system. This intervention was designed and implemented by Professor Balint in 1957 and has been implemented around the world since then. The method of this intervention is in the form of a group in such a way that 12-14 members of the medical staff who have been selected homogeneously (have the same job) come together for 60 minutes with the presence of two group leaders in a group structure. The arrangement of the group is in the form of a ring. First, for 10 minutes, under the guidance of the leader and chosen by the group members, one person talks about his emotional experience in the work environment, especially in relation to the patient, then that person is removed from the group for 35 minutes.(The person stays in the group space and outside the circle.) And the rest of the group members talk about this person's emotional experience in an empathetic way, focusing on their own experiences. The leader directs the atmosphere of the group in order to better understanding the expressed experience and regulate people's emotions and empathy and performs the necessary interventions to reduce the emotional burden of the topic of discussion. Then, in the last 15 minutes, the first person enters the group and expresses his feelings and experience from listening to the talks of others and the group leaders, and the group leader analyzes the psychodynamic components of the relationship with the patient.</i_keyword>
      <i_keyword>Control group: Psychoeducation group: For this group, 6 sessions of psychoeducation will be held in such a way that each session will last for 60 minutes. The people of this group will be trained in psychological issues related to grief in the form of attending a training class. Sessions include: The first session talks about the definition of grief. The second session is about types of mourning. The third session is about the stages of mourning from the perspective of Kubler-Ross. The fourth session is about therapeutic and psychological interventions in bereavement. The fifth session is about stress control. The sixth session will be about emotion regulation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Job burnout. Timepoint: At the beginning of the study ( before the intervention) and at the end of the work. Method of measurement: Mezlach's burnout questionnaire (severity scale).</prim_outcome>
      <prim_outcome>Empathy with patients. Timepoint: At the beginning of the study ( before the intervention ) and at the end of the work. Method of measurement: Jefferson's empathy 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-02</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Shohadaye Gomnam Blvd. Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
