<?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>IRCT20151020024625N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-30</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Balint group work and compassion focus group therapy on quality of life, burnout and   psychosomatic syndrome in emergency department's nurses</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of Balint group work and compassion focus group therapy on quality of life, burnout and   psychosomatic syndrome in emergency department's nurses, Kowsar hospital, Semnan, 2022</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>39</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63147</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For randomization, at first stage, 39 spheres from one to 39 are considered and following that will randomly assigned into three groups, including "1" (Intervention, Balint group) and group 2 (Intervention, compassion focus group) and group 3 (Control group), in this way, the first ball is assigned to the first group (Intervention, Balint group), the second ball to the second group  (Intervention, compassion focus group)  and the third ball to the third group (Control group), and the process is repeated and the intended sequence will be recorded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Quality of life. Condition 2: Burnout. Condition 3: Psychosomatic disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the first group, weekly Balint sessions are held for 8 weeks. Each session is 60-90 minutes. The group's leader is researcher and is the only one who can indirectly offer solutions and suggestions. In each session, participants expresses an emotional traumatic events which they was experienced, put them at a crossroads, or have a mental repetition. A topic is selected from the topics and the narrator is asked to describe the situation and feelings at that time and the present moment. The members of the group are completely silent as long as the narrator speaks. After the narrator has spoken, he is asked to leave the group and sit and watch. The leader then asks the group members to talk about bodily feelings or similar experiences without any judgment and to ask the narrator questions for more information, the narrator has the right to answer or not. Finally, the leader concludes and indirectly suggests solutions to the narrator. Intervention 2: Intervention group: For the second group, weekly sessions compassion-focused group therapy are held for 8 weeks. The first session includes initial communication, pre-test, general principles of compassion therapy and distinguishing regret from  compassion, conceptualizing of self-compassion education. The second session is mindfulness training along with physical examination and breathing exercises,being familiar with brain systems based on compassion, empathy training, training to make people understand that they feel they can handle the situation with a sympathetic attitude. The third session is Becoming familiar with the characteristics of people with compassion, feeling compassion for others, cultivating the feelings of warmth and kindness to oneself, developing the understanding that others also have flaws and problemsin the face of self-destructive feelings and shame (cultivating a sense of human commonalities), teaching empathy. Forth session: encouraging the subjects to self-knowledge and examine their personality according to educational topics; identifying oneself as a non-compassionate or compassionate person;identifying oneself as a person who values self-compassion, empathy and sympathy;developing a compassionate mind;applying exercises to oneself and others; teaching the physiotherapist metaphor, teaching forgiveness. Fifth session:Performing compassionate mind developing exercises; reviewing the previous session; being familiar and applying forgiveness, acceptance without judgment, teaching the metaphor of the flu, and teaching patience; teaching acceptance of issues; accepting the changes ahead; enduring difficult and challenging situations considering the changing nature of life and confronting with different challenges. Sixth session: creating compassionate images practically, teaching styles and methods of expressing compassion (verbal compassion, practical compassion, intermittent compassion, and continuous compassion); applying these methods in daily life and for spouse, children, parents, friends, teachers, and acquaintances; teaching the developing valuable and transcendent emotions. Seventh session:  teaching writing compassionate letters for oneself and others, teaching dailyregistering and recording real situations based on compassion and individual's performance in applying this method in that situation. Eighth session: Training and practicing skills, reviewing and practicing the skills presented in previous sessions forhelping subjects to confront different situation in different ways; final summarizing, and providing solutions to maintain and apply this therapeutic method in everyday life. Intervention 3: Control group: The control group will participate in pre-test and post-test and will not receive any intervention during the research. But, based on ethical issues, control group are placed on a waiting list for training, and after conducting research and obtaining results, a method that is more effective will be implemented on them.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roza Salehian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3800 2000</telephone>
        <email>dr.roza.salehian@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roza Salehian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3800 2000</telephone>
        <email>dr.roza.salehian@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>َJob exprience at least 3 years
Nurses working in the emergency department</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a second job
Physical or mental illness
Receiving any type of psychotherapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code>Z73.0</hc_code>
      <hc_code>F45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Burn-out</hc_keyword>
      <hc_keyword>Somatoform disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the first group, weekly Balint sessions are held for 8 weeks. Each session is 60-90 minutes. The group's leader is researcher and is the only one who can indirectly offer solutions and suggestions. In each session, participants expresses an emotional traumatic events which they was experienced, put them at a crossroads, or have a mental repetition. A topic is selected from the topics and the narrator is asked to describe the situation and feelings at that time and the present moment. The members of the group are completely silent as long as the narrator speaks. After the narrator has spoken, he is asked to leave the group and sit and watch. The leader then asks the group members to talk about bodily feelings or similar experiences without any judgment and to ask the narrator questions for more information, the narrator has the right to answer or not. Finally, the leader concludes and indirectly suggests solutions to the narrator.</i_keyword>
      <i_keyword>Intervention group: For the second group, weekly sessions compassion-focused group therapy are held for 8 weeks. The first session includes initial communication, pre-test, general principles of compassion therapy and distinguishing regret from  compassion, conceptualizing of self-compassion education. The second session is mindfulness training along with physical examination and breathing exercises,being familiar with brain systems based on compassion, empathy training, training to make people understand that they feel they can handle the situation with a sympathetic attitude. The third session is Becoming familiar with the characteristics of people with compassion, feeling compassion for others, cultivating the feelings of warmth and kindness to oneself, developing the understanding that others also have flaws and problemsin the face of self-destructive feelings and shame (cultivating a sense of human commonalities), teaching empathy. Forth session: encouraging the subjects to self-knowledge and examine their personality according to educational topics; identifying oneself as a non-compassionate or compassionate person;identifying oneself as a person who values self-compassion, empathy and sympathy;developing a compassionate mind;applying exercises to oneself and others; teaching the physiotherapist metaphor, teaching forgiveness. Fifth session:Performing compassionate mind developing exercises; reviewing the previous session; being familiar and applying forgiveness, acceptance without judgment, teaching the metaphor of the flu, and teaching patience; teaching acceptance of issues; accepting the changes ahead; enduring difficult and challenging situations considering the changing nature of life and confronting with different challenges. Sixth session: creating compassionate images practically, teaching styles and methods of expressing compassion (verbal compassion, practical compassion, intermittent compassion, and continuous compassion); applying these methods in daily life and for spouse, children, parents, friends, teachers, and acquaintances; teaching the developing valuable and transcendent emotions. Seventh session:  teaching writing compassionate letters for oneself and others, teaching dailyregistering and recording real situations based on compassion and individual's performance in applying this method in that situation. Eighth session: Training and practicing skills, reviewing and practicing the skills presented in previous sessions forhelping subjects to confront different situation in different ways; final summarizing, and providing solutions to maintain and apply this therapeutic method in everyday life.</i_keyword>
      <i_keyword>Control group: The control group will participate in pre-test and post-test and will not receive any intervention during the research. But, based on ethical issues, control group are placed on a waiting list for training, and after conducting research and obtaining results, a method that is more effective will be implemented on them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: 8 Weeks after intervention. Method of measurement: The World Health Organization's Quality of Life Questionnaire (WHOQOL-Bref).</prim_outcome>
      <prim_outcome>Burn-out. Timepoint: 8 Weeks after intervention. Method of measurement: Maslach Burnout Inventory.</prim_outcome>
      <prim_outcome>Psychosomatic disorder. Timepoint: 8 Weeks after intervention. Method of measurement: Diagnostic Criteria for Psychosomatic Research (DCPR).</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>2021-06-26</approval_date>
        <contact_name>Ethics committee of Medical Faculty, Mashhad University of Medical Sciences</contact_name>
        <contact_address>Azadi Square, Easter Enterance of Pardis Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
