<?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>IRCT20181118041692N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-11</date_registration>
      <primary_sponsor>Neyshabour University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Pilates exercise on anxiety and self-esteem</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Pilates exercise on anxiety and self-esteem in medical emergencies students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35397</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to randomly assign individuals to the two groups and guarantee the balance of the number of individuals in the groups, a random block method will be used. In this study, four-dimensional blocks will be created in which randomly half of the individuals in each block will be in one group and half in the other group. To do this, first all of the possible modes that half of the subjects are assigned to group A (test group) and the other half to the group B (control group) are determined:

1-AABB
2-BBAA
3-ABAB
4-BABA
5-ABBA
6-BAAB
Then each of the four combinations will be one of the digits 1 to 6, and from numbers 1 through 6 randomly, repeated choices are made with the placement. Selected blocks are tagged in a sequential sequence, and according to the sequence, the individuals entered into the study will be assigned to one of the two groups A or B. Random selection of blocks will continue to reach the sample size of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Anxiety. Condition 2: Self-esteem.</hc_freetext>
      <i_freetext>Intervention 1: Pilates exercises are conducted in the course of 8 weeks twice a week for 60 minutes with the coach. The amount of anxiety and self-esteem in the beginning of the intervention and eight weeks after the intervention was assessed using the Spielberger Anxiety Inventory and the Cooper Smith Questionnaire. Intervention 2: Control group: Continue their daily activities. The amount of anxiety and self-esteem was completed by using the Spielberger Anxiety Questionnaire and the Cooper Smith Questionnaire before and after the intervention at the end of the study, in coincidence with the intervention group time.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zZohreh Ssarchahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Janbazan Blvd, Neyshabour University of Medical Sciences</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9319913589</zip>
        <telephone>+98 51 4261 3294</telephone>
        <email>zohrehsarchahi@gmail.com</email>
        <affiliation>Neyshabour University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh Sarchahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Janbazan Blvd, Neyshabour University of Medical Sciences</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9319913589</zip>
        <telephone>+98 51 4261 3294</telephone>
        <email>zohrehsarchahi@gmail.com</email>
        <affiliation>Neyshabour University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>the age is between 19-30 years old
Student studying medical emergencies</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>having previous history of physical and mental illness
tension problems in the last 6 weeks
Exercise regularly in the last month
use of drugs and sedative medicines</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41</hc_code>
      <hc_code>F88</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
      <hc_keyword>Other disorders of psychological development</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Pilates exercises are conducted in the course of 8 weeks twice a week for 60 minutes with the coach. The amount of anxiety and self-esteem in the beginning of the intervention and eight weeks after the intervention was assessed using the Spielberger Anxiety Inventory and the Cooper Smith Questionnaire.</i_keyword>
      <i_keyword>Control group: Continue their daily activities. The amount of anxiety and self-esteem was completed by using the Spielberger Anxiety Questionnaire and the Cooper Smith Questionnaire before and after the intervention at the end of the study, in coincidence with the intervention group time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Beginning of the intervention and eight weeks after the intervention. Method of measurement: Spilberger's apparent and hidden anxiety questionnaire.</prim_outcome>
      <prim_outcome>Self-esteem. Timepoint: Beginning of the intervention and eight weeks after the intervention. Method of measurement: Cooper Smith questionnaire.</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>Neyshabour University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-16</approval_date>
        <contact_name>Neyshabour University of Medical Sciences</contact_name>
        <contact_address>Neyshabour University of Medical Sciences, Janbazan Blvd Neyshabour Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
