<?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>IRCT2014053113776N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-14</date_registration>
      <primary_sponsor>Golestan university of medical Sciences</primary_sponsor>
      <public_title>Body Psychotherapy Techniques (BPT)  on stress</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Body Psychotherapy Techniques (BPT)  on stress and salivary cortisol level in High School Students in Gorgan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13556</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Stress.</hc_freetext>
      <i_freetext>Intervention 1: Treatment group will receive educational sessions after pre-test of Cohn stress scale. Salivary cortisol samples will be collected pre and post educational sessions a brief description of sessions of body-psychotherapy is as follows: session1: empathy between therapist and clients, between clients, description of group rules by therapist, introduction to body-psychotherapy. Session2: introduction to body-psychotherapy, exploration of stressors and physiologic symptoms of stress in the body, providing information to increase awareness through body exercises, giving homework such as writing daily experience of body responses in stressful conditions. Session3: discussion about personal experience of group members, training breath practice to overcome stress and concentration on body, teaching how a person can communicate with ignored parts of body, giving homework. Session 4: performing breath practice, relaxation of stressful body organs, providing information regarding defense, avoidance, blocks and trauma on stress level, Training of radix and bioenergetics techniques, giving homework. Session5: exploration of blocks, avoidances, defenses and traumas by group members, evaluation of body emotions and their relations to avoidances, blocks, traumas, giving homework. Session 6: description of boundary between self and others,   ability to feel yourself and others, teaching shiron and embodied relational therapy, giving homework. Session7: providing information regarding integrity of body and psyche, description of conscious control, teaching somatic and emotional therapy techniques, giving homework. Session 8: mindfulness regarding body sensations, emotions and memories, teaching Hakomi technique, giving homework. Session9: review of previous sessions,  summary of sessions, performing post-test of Cohn stress scale and asking for collecting salivary cortisol in the next morning. Intervention 2: For control group, we perform Cohn stress scale test as treatment group. Moreover, salivary cortisol will be collected at the same time schedule. Control group will not receive educational sessions.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Javan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Ale Ahmad Nasr Bridge</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4483 0725</telephone>
        <email>mjavan@modares.ac.ir</email>
        <affiliation>Tarbiat Modarress University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hossein Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shast Kola, Km 2 Sari</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 17 1552 5972</telephone>
        <email>haminhplc@yahoo.com</email>
        <affiliation>Golstan Universty of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Healthy, female, student, High stress&#13;
Exclusion: PMS syndrome, Menstural period</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Treatment group will receive educational sessions after pre-test of Cohn stress scale. Salivary cortisol samples will be collected pre and post educational sessions a brief description of sessions of body-psychotherapy is as follows: session1: empathy between therapist and clients, between clients, description of group rules by therapist, introduction to body-psychotherapy. Session2: introduction to body-psychotherapy, exploration of stressors and physiologic symptoms of stress in the body, providing information to increase awareness through body exercises, giving homework such as writing daily experience of body responses in stressful conditions. Session3: discussion about personal experience of group members, training breath practice to overcome stress and concentration on body, teaching how a person can communicate with ignored parts of body, giving homework. Session 4: performing breath practice, relaxation of stressful body organs, providing information regarding defense, avoidance, blocks and trauma on stress level, Training of radix and bioenergetics techniques, giving homework. Session5: exploration of blocks, avoidances, defenses and traumas by group members, evaluation of body emotions and their relations to avoidances, blocks, traumas, giving homework. Session 6: description of boundary between self and others,   ability to feel yourself and others, teaching shiron and embodied relational therapy, giving homework. Session7: providing information regarding integrity of body and psyche, description of conscious control, teaching somatic and emotional therapy techniques, giving homework. Session 8: mindfulness regarding body sensations, emotions and memories, teaching Hakomi technique, giving homework. Session9: review of previous sessions,  summary of sessions, performing post-test of Cohn stress scale and asking for collecting salivary cortisol in the next morning.</i_keyword>
      <i_keyword>For control group, we perform Cohn stress scale test as treatment group. Moreover, salivary cortisol will be collected at the same time schedule. Control group will not receive educational sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: 9 weeks. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Salivary cortisol. Timepoint: 0, 15th, 30th and 45th minutes. Method of measurement: ELISA kit.</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>Golestan university of medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-26</approval_date>
        <contact_name>tarbiat Modarres Uinversity</contact_name>
        <contact_address>Jalal Ale Ahmad, Nasr bridge Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
