<?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>IRCT20181203041832N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-05</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of online mindfulness training on mental health and quality of work life of nurses fighting on the frontlines against COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of online mindfulness training based on stress reduction (MBSR) on mental health and quality of work life of nurses fighting on the frontlines against COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50750</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In this study, the intervention group will be trained for 8 weeks, but the control group will not receive any training and after completing the research, will participate in this course if desired, Randomization description: Due to the fact that patients with  COVID-19 are admitted to Taleghani Hospital in Urmia, so first to achieve the objectives of the study and according to the conditions of admission, 36 people will be selected based on purposive sampling. Then this number will be divided into two groups of intervention (n = 18) and control (n = 18) completely randomly. It should be noted that the selected samples will be coded from number one to 36 and then will be placed in one of the intervention or control groups based on the table of random numbers, Blinding description: It should be noted that first the subjects will be explained about the objectives of the study and after their agreement to participate in the present study will be selected as the study sample, in the present study only responsible for data analysis about the objectives of the study , Will be kept blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>There is not disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Nurses working on frontline of fighting against COVID-19 disease. The intervention that is to be done in this scientific study is: Mindfulness-Based Stress Reduction (MBSR). Mindfulness-based stress reduction is a group program that was developed by Jon Kabat-Zinn in the 1970s to treat patients struggling with life’s difficulties and physical and/or mental illness (Kabat-Zinn, 2013). This training course is held in 8 online sessions (one session of 1.5 hours per week) for the nurses of the intervention group. Formal exercises include: 1. Body Scan 2. The Breath (exercise that facilitates mindfulness by focusing on the breath). 3. Mindful Eating 4. Sitting exercise 5.Walking Meditation 6.Mindful Stretching 7. Simply Watching. Intervention 2: Control group: Will not receive any intervention until the research project is completed.</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 Due to the confidentiality and confidentiality of personal data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naser Gharebaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Resalat Boulevard. University of Medical Sciences</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>57147-83734</zip>
        <telephone>+98 44 3193 7286</telephone>
        <email>gharabaghi.n@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haedeh Feizipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Resalat Boulevard. University of Medical Sciences</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>57147-83734</zip>
        <telephone>+98 44 3193 7286</telephone>
        <email>h.feizipour@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Full time employee
At least 2 years of service
At least 3 months of work experience in the "ICU" (due to adaptation to the work environment)
Ability to use an online application through an Internet-connected device (e.g. smartphone, computer or laptop)
Access the online Skyroom app
Non-interference of the training program with nurses' shifts
Provided that the medication is taken, inform the researchers if the dose of the medication is stable during the exercise, or if the dose changes
Commitment to daily mindfulness exercises and active participation in the training course.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute psychiatric illnesses such as psychosis
Psychiatric medication for the past 6 months
Acute physical illness with pain that prevents exercise
Addiction to drugs and alcohol
Previous experiences of mindfulness
Psychological interventions or counseling during exercise from other sources
Facing a severe traumatic event in the last 6 months</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>Treatment - Other</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The Nurses working on frontline of fighting against COVID-19 disease. The intervention that is to be done in this scientific study is: Mindfulness-Based Stress Reduction (MBSR). Mindfulness-based stress reduction is a group program that was developed by Jon Kabat-Zinn in the 1970s to treat patients struggling with life’s difficulties and physical and/or mental illness (Kabat-Zinn, 2013). This training course is held in 8 online sessions (one session of 1.5 hours per week) for the nurses of the intervention group. Formal exercises include: 1. Body Scan 2. The Breath (exercise that facilitates mindfulness by focusing on the breath). 3. Mindful Eating 4. Sitting exercise 5.Walking Meditation 6.Mindful Stretching 7. Simply Watching</i_keyword>
      <i_keyword>Control group: Will not receive any intervention until the research project is completed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression Score in Symptom Checklist 90-Revised  (SCL-90-R). Timepoint: Before intervention - Immediately after intervention - One month after intervention. Method of measurement: Symptom Checklist 90-Revised  (SCL-90-R).</prim_outcome>
      <prim_outcome>Stress score in the Symptom Checklist 90-Revised  (SCL-90-R). Timepoint: Before - after - one month after the intervention. Method of measurement: Symptom Checklist 90-Revised  (SCL-90-R).</prim_outcome>
      <prim_outcome>Pathological fear score in the Symptom Checklist / SCL 90. Timepoint: Before - after - one month after the intervention. Method of measurement: Symptom Checklist 90-Revised  (SCL-90-R).</prim_outcome>
      <prim_outcome>Psychosomatic disorders score in the Symptom Checklist 90-Revised  (SCL-90-R). Timepoint: Before - after - one month after the intervention. Method of measurement: Symptom Checklist 90-Revised  (SCL-90-R).</prim_outcome>
      <prim_outcome>ََAggression score in the mental disorders Symptom Checklist 90-Revised  (SCL-90-R). Timepoint: Before - after - one month after the intervention. Method of measurement: Symptom Checklist 90-Revised  (SCL-90-R).</prim_outcome>
      <prim_outcome>Obsessive-compulsive disorder score in the symptom checklist scl90. Timepoint: Before - after - one month after the intervention. Method of measurement: Symptom Checklist 90-Revised  (SCL-90-R).</prim_outcome>
      <prim_outcome>Interpersonal Sensitivity Score in Symptom Checklist 90-Revised  (SCL-90-R). Timepoint: Before - after - one month after the intervention. Method of measurement: Symptom Checklist 90-Revised  (SCL-90-R).</prim_outcome>
      <prim_outcome>Quality of work life score in the Work‐Related Quality of Life scale for healthcare workers. Timepoint: Before - after - one month after the intervention. Method of measurement: The Work‐Related Quality of Life scale for healthcare workers.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-02</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Jahad Square, Resalat Blvd.,  Emergency Alley, Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
