<?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>IRCT20210616051603N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of mindfulness on coronary anxiety and the immune system</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Mindfulness Exercises on Coronary Anxiety and Immune System on Clinical Psychology Students of Lahijan Islamic Azad University</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56950</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: At first, according to the inclusion criteria, patients are selected and then according to the random sequence obtained through random allocation software, patients will be randomly divided into experimental and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Corona anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Students of clinical psychology are Lahijan Branch of Azad University. The statistical population of this study will consist of all master students of clinical psychology studying at the Islamic Azad University, Lahijan Branch in the academic year 1399-1400. According to available statistics, the number of these people is 160. 20 students will be selected at random and will be randomly assigned to two groups (10 in the experimental group and 10 in the control group). In relation to therapeutic intervention and data collection, the following protocols and tools will be used: - Mindfulness training package: In this research, mindfulness training package will be used for intervention. This package is based on mindfulness-based cognitive therapy and was developed by Van Soon et al. (2011). The package is presented in 8 sessions (90 minutes) which includes mindfulness training with breathing, detailed body examination training, bipolar confrontation training, familiarity with bodily senses, empathy and observation of thoughts without judgment. . Mindfulness treatment program is performed for one month (4 weeks) twice a week for 90 minutes. Anxiety Scale: In this study, to measure the level of anxiety of the subjects, a scale made by Alipour et al. (1398) with 18 questions will be used. This questionnaire is scored in the 4-point Likert scale (never = 0, sometimes = 1, most times = 2 and always = 3). In total, the subjects' score varies between zero and 54. The high score in this questionnaire indicates a higher level of anxiety in individuals. Post-test sessions are also taken at the end. Intervention 2: Control group: There are students of clinical psychology at Lahijan Azad University who do not receive mindfulness training. A total of 20 students were selected by random sampling into two groups (10 in the experimental group and 10 in the control group). Will be allocated. Anxiety Scale: In this study, to measure the level of anxiety of the subjects, a scale made by Alipour et al. (1398) with 18 questions will be used. This questionnaire is scored in the 4-point Likert scale (never = 0, sometimes = 1, most times = 2 and always = 3). In total, the subjects' score varies between zero and 54. The high score in this questionnaire indicates a higher level of anxiety in individuals.</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:
The total results obtained from the results of the questionnaire and testing and performance improvement will be published

When:
Access period starts from September 1400

To whom:
Data and other documents are available to all researchers in the field of research

Conditions:
If other people request data and documentation, send a message to my personal email.

Where to obtain:
Applicants should refer to Lahijan, Kashif Sharghi St., at the end of Shaghayegh St., Lahijan Branch of Azad University, to receive the required documents or data. Mahmoud Rezaei Bosari by phone number 09377688854 and email
mahmoodrezaei776@gmail.com
Is responsive

How to obtain:
Applicants should call 09377688854 or send an email to mahmoodrezaei776@gmail.com8 to receive the required documents or data. Documents will be provided to them within 72 hours to a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahmoud Rezaei  Bousari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 69, Villag Galeshkheil, Pirbazar</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4165159577</zip>
        <telephone>+98 13 3381 3345</telephone>
        <email>mahmoodrezaei776@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahmoud Rezaei Bousari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 69, Villag Galeshkheil, Pirbazar</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4165159577</zip>
        <telephone>+98 13 3381 3345</telephone>
        <email>mahmoodrezaei776@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All clinical psychology students of Islamic Azad University, Lahijan Branch</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Those who have received the Corona vaccine
People with anxiety disorders</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Students of clinical psychology are Lahijan Branch of Azad University. The statistical population of this study will consist of all master students of clinical psychology studying at the Islamic Azad University, Lahijan Branch in the academic year 1399-1400. According to available statistics, the number of these people is 160. 20 students will be selected at random and will be randomly assigned to two groups (10 in the experimental group and 10 in the control group). In relation to therapeutic intervention and data collection, the following protocols and tools will be used: - Mindfulness training package: In this research, mindfulness training package will be used for intervention. This package is based on mindfulness-based cognitive therapy and was developed by Van Soon et al. (2011). The package is presented in 8 sessions (90 minutes) which includes mindfulness training with breathing, detailed body examination training, bipolar confrontation training, familiarity with bodily senses, empathy and observation of thoughts without judgment. . Mindfulness treatment program is performed for one month (4 weeks) twice a week for 90 minutes. Anxiety Scale: In this study, to measure the level of anxiety of the subjects, a scale made by Alipour et al. (1398) with 18 questions will be used. This questionnaire is scored in the 4-point Likert scale (never = 0, sometimes = 1, most times = 2 and always = 3). In total, the subjects' score varies between zero and 54. The high score in this questionnaire indicates a higher level of anxiety in individuals. Post-test sessions are also taken at the end.</i_keyword>
      <i_keyword>Control group: There are students of clinical psychology at Lahijan Azad University who do not receive mindfulness training. A total of 20 students were selected by random sampling into two groups (10 in the experimental group and 10 in the control group). Will be allocated. Anxiety Scale: In this study, to measure the level of anxiety of the subjects, a scale made by Alipour et al. (1398) with 18 questions will be used. This questionnaire is scored in the 4-point Likert scale (never = 0, sometimes = 1, most times = 2 and always = 3). In total, the subjects' score varies between zero and 54. The high score in this questionnaire indicates a higher level of anxiety in individuals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in Aliniya Anxiety Questionnaire. Timepoint: Measuring anxiety at the beginning of the study and eight sessions after the start of mindfulness training. Method of measurement: Aliniya Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Corona antibody test response. Timepoint: Corona antibody test at the beginning of the study and eight sessions after the start of mindfulness training. Method of measurement: IGg, IGm.</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>Lahijan Branch of Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-24</approval_date>
        <contact_name>Ethics Committee of Lahijan Branch of Azad University</contact_name>
        <contact_address>No 69, Villag Galeshkheil, Pirbazar Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
