<?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>IRCT20190604043813N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-11</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of "Mindfulness-based Stress Reduction" (MBSR) on mood disorders</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effectiveness and sustainability of "Mindfulness-based Stress Reduction (MBSR)" education on Depression, Anxiety and Stress Scale (DASS-21) score  in nurses and comparing it with control group.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53253</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Each one-hour session is a combination of training method including education by video (half an hour) and theoretical and practical training (half an hour), Randomization description: Participants will be randomly allocated to one of the 2 groups in this trial by block randomization given a block size of 4. For this propose  these steps must be followed: First the list of nurses staff of the organization will be provided, then by a randomization software at https://www.sealedenvelope.com/simple-randomiser/v1/lists, a blocked randomization list will be created given block size of 4 and list length of 68.  Allocation is based on matching the number of two lists (randomization list and list which is provided by organization) so each case is assigned to a group A or B, Blinding description: The questionnaire will be delivered to participant in the workplace by a hospital staff who is unaware of group allocation .The results will enter in SPSS20 and analyze  by a statistician who is unaware of the group allocation.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Anxiety. Condition 3: Stress. Condition 4: Occupational burnout.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will be given 4 training sessions one hour per week for 4 consecutive weeks in which the Mindfulness-Based Stress Reduction (MBSR) program will be moderated by the respective assistant as well as instructional videos. During this time the control group received no training.The session schedule is as follows. The first session: half hour presenting the video "Power of mindfulness" and the second half hour lecture of Body scan7 myths of meditation, The second session: first half hour presenting the video "Don't try to be mindful" and The second half hour the lecture Why you find it hard to meditate , The third session the first half hour presenting the video "Raisin meditation" and the second half hour of brain-rewires, The forth session: half hour presenting the video Attention, intention attitude and the second half hour of Sitting Meditation and Your mind lecture . At the end of each session meditation is done for about 10 minutes. Exact titles and educational materials have been extracted from the site https://palousemindfulness.com/. An experienced psychiatrist in this field is responsible for training the intervention group. Intervention 2: Control group: No intervention will be done. Only the questionnaires will be completed before, after, and three months after training.</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 potential data can be shared after the participant become unidentifiable.

When:
After article acceptance

To whom:
َAll who request to use data in other related research

Conditions:
To use data in other related research only if the source of information be mentioned in the related research

Where to obtain:
hhaghighi@sums.ac.ir

How to obtain:
Provided that the applicant explains the program and title of his research project, the cooperation of one of the researchers in this project in the research project of the applicant as one of the authors and also mentioning the source of information, information will be provided to him as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hourvash Akbari Haghighinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Family medicine department, Namazi hospital. Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7184983858</zip>
        <telephone>+98 71 3647 4967</telephone>
        <email>hhaghighi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hourvash Akbari Haghighinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand street, Namazi hospital, Family medicine department</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7184983858</zip>
        <telephone>+98 71 3647 4967</telephone>
        <email>hhaghighi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willing to participate in the project
Having a therapeutic activity as a nurse in the health and treatment  organization of Fars oil industry who work in Shiraz city</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age over 65 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
      <hc_code>F41</hc_code>
      <hc_code></hc_code>
      <hc_code>Z73.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Burn-out</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will be given 4 training sessions one hour per week for 4 consecutive weeks in which the Mindfulness-Based Stress Reduction (MBSR) program will be moderated by the respective assistant as well as instructional videos. During this time the control group received no training.The session schedule is as follows. The first session: half hour presenting the video "Power of mindfulness" and the second half hour lecture of Body scan7 myths of meditation, The second session: first half hour presenting the video "Don't try to be mindful" and The second half hour the lecture Why you find it hard to meditate , The third session the first half hour presenting the video "Raisin meditation" and the second half hour of brain-rewires, The forth session: half hour presenting the video Attention, intention attitude and the second half hour of Sitting Meditation and Your mind lecture . At the end of each session meditation is done for about 10 minutes. Exact titles and educational materials have been extracted from the site https://palousemindfulness.com/. An experienced psychiatrist in this field is responsible for training the intervention group.</i_keyword>
      <i_keyword>Control group: No intervention will be done. Only the questionnaires will be completed before, after, and three months after training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>DASS-21 (depression , anxiety, stress) questionnaire score. Timepoint: Before and after training and 3 months after training. Method of measurement: DASS-21 (depression , anxiety, stress) questionnaire score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Copenhagen burnout questionnaire score. Timepoint: Before and after training and 3 months after training. Method of measurement: Copenhagen burnout questionnaire score.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-22</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Family Medicine Department, Namazi Hospital. Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
