<?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>IRCT20200312046754N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-25</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Educational Relaxation on Stress, Anxiety and Depression among Woman Teachers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of relaxation educational intervention on Stress, Anxiety and Depression in female primary school teachers in education district 3 of Isfahan.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46579</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, teachers will be included who according to the DASS-42 questionnaire have a score of 43 and more than 43. After selecting the teachers, the list of their names will be provided respectively for the researcher   in numbers (1 to 100), and each of them will be randomly divided into two groups of intervention (even numbers) and control (odd numbers). None of them will be informed  about their situation and others situation in each group and they will not have any connection with each other, Blinding description: In this study, the researcher is aware of who is in the intervention group and who is in the control group. And participants are completely unaware of which intervention and control groups they belong to and they are kept blind.  Relaxation exercises will be provided to those who will be in the intervention group. persons who are in the control group after the intervention, sample collection, and post-test will receive educational content.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Stress. Condition 2: . Condition 3: .</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention is in both face-to-face sessions and virtual education. In-person sessions consist of six in-person training sessions (one training session per week) by a health educator and psychosomatic specialist. The duration of each training session is one and a half hours. Each session includes both theoretical concepts and relaxation training exercises. Relaxation exercises include diaphragmatic breathing, tension release, control keys, vibrating gestures, establishment and meditation, and each session provides one of its exercises with related theoretical concepts. In each session, first the theoretical concepts are taught for one hour, then 30 minutes for relaxation exercises.WhatsApp will be used by the health educator in the virtual training program, with one or two training messages per week about relaxation and summarize training sessions in person (in audio or text message) in the group. In addition, a reminder message will be sent every day to people to do the exercises and people tell the health educator if they do the exercises. The group will also be used to track participants and solve their educational problems. Intervention 2: Control group: From the beginning to the end of the training interventions, no educational interventions will be performed for the control group about the research topic, and they will do their routine work. The samples in this study are teachers and they perform activities that related to their job, but they do not receive any intervention in the field of research plan such as referring to a counselor, psychologist or receiving medication related to treatment in the field of psychology. After collecting data from both groups in the post-test, educational files will be provided to control group for use.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Since the work has not yet entered the implementation phase, there is no decision on whether or not to share individual data. There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Aboutalebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Shahid Mohammadi Alley, Keshavarzi Avenue, Keshavarz Blvd</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174898131</zip>
        <telephone>+98 31 3776 3081</telephone>
        <email>zahra73abid@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Aboutalebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Shahid Mohammadi Alley, Keshavarzi Avenue, Keshavarz Blvd</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174898131</zip>
        <telephone>+98 31 3776 3081</telephone>
        <email>zahra73abid@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a score of 43 and more from the DASS-42 questionnaire
Willingness to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having major mental and physical disease that barrier training</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z56.3</hc_code>
      <hc_code>-</hc_code>
      <hc_code>-</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stressful work schedule</hc_keyword>
      <hc_keyword>-</hc_keyword>
      <hc_keyword>-</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention is in both face-to-face sessions and virtual education. In-person sessions consist of six in-person training sessions (one training session per week) by a health educator and psychosomatic specialist. The duration of each training session is one and a half hours. Each session includes both theoretical concepts and relaxation training exercises. Relaxation exercises include diaphragmatic breathing, tension release, control keys, vibrating gestures, establishment and meditation, and each session provides one of its exercises with related theoretical concepts. In each session, first the theoretical concepts are taught for one hour, then 30 minutes for relaxation exercises.WhatsApp will be used by the health educator in the virtual training program, with one or two training messages per week about relaxation and summarize training sessions in person (in audio or text message) in the group. In addition, a reminder message will be sent every day to people to do the exercises and people tell the health educator if they do the exercises. The group will also be used to track participants and solve their educational problems.</i_keyword>
      <i_keyword>Control group: From the beginning to the end of the training interventions, no educational interventions will be performed for the control group about the research topic, and they will do their routine work. The samples in this study are teachers and they perform activities that related to their job, but they do not receive any intervention in the field of research plan such as referring to a counselor, psychologist or receiving medication related to treatment in the field of psychology. After collecting data from both groups in the post-test, educational files will be provided to control group for use.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: Measurement of stress score before intervention, 55 and 85 days after intervention. Method of measurement: The Depression, Anxiety and Stress Scale-(DASS)42.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Measurement of anxiety score before intervention, 55 and 85 days after intervention. Method of measurement: The Depression, Anxiety and Stress Scale-(DASS)42.</prim_outcome>
      <prim_outcome>ِDepression. Timepoint: Measurement of depression score before intervention, 55 and 85 days after intervention. Method of measurement: The Depression, Anxiety and Stress Scale-(DASS)42.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-11</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>َAssistance for research and technology,Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
