<?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>IRCT2015081623640N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-10</date_registration>
      <primary_sponsor>Vice Chancellor of Research Technolog, Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise on the vitality and positive emotion primigravid</public_title>
      <acronym></acronym>
      <scientific_title>The effects of physical exercise on positive emotion and vitality of primigravid women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20146</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effects of physical exercise on positive emotion and vitality of primigravid women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The classes will be held every two weeks for an hour and a half, for 8 times, with a maximum of 10 pregnant women, and includes 5 minutes of greetings, 30 minutes of training, 10 minutes for questions and answers, 30 minutes of physical exercise, and 10-15 minutes of relaxation, and the last 10-15 minutes is dedicated to video playback and questions and answers. Mothers wear comfortable clothes at the time of exercises and do their workouts with the trainer for 30 minutes at a suitable place. Mothers are recommended to do exercises and relaxation at home every day, and every two days, mother will receive a phone call, and they will be encouraged to exercise at home. After 36 weeks of the end of the classes, the questionnaires will be completed again by test group. Then the data analysis will be conducted and the results of the impacts of training and exercise classes on positive affection and vitality before and after the intervention. Intervention 2: The control group: receives the routine cares of prenatal clinic. and In order to regard the ethical principles in the control group, after the completion of training, they will be given educational pamphlet After 36 weeks of the end of the classes, the questionnaires will be completed again by control group. Then the data analysis will be conducted and the results of the impacts of training and exercise classes on positive affection and vitality before and after the intervention.</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 farzaneh soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>school of Nursung dnd Midwifery,Hamedan Universty of Medical Sience,Shahid Fahmideh Ave,Hamedan</address>
        <city>hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516845977</zip>
        <telephone>+98 81 3838 0150</telephone>
        <email>sa.ghelichkhani@gmail.com</email>
        <affiliation>Hamedan Univercity of Medical Sience</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr farzaneh soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>school of Nursung dnd Midwifery,Hamedan Universty of Medical Sience,Shahid Fahmideh Ave,Hamedan</address>
        <city>hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516645977</zip>
        <telephone>+98 81 3838 0150</telephone>
        <email>farzanehsoltani2008@yahoo.com</email>
        <affiliation>University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria to study:" gestational age of 20 weeks or more"؛" lack of anxiety and depression and lack of psychoactive medications before pregnancy and during pregnancy, according to doctor's comments and patient records in health center"؛" normal pregnancy without midwifery and medical side effects" Exclusion criterion:" more than two times of absence in classes"؛" the incidence of unpleasant life events"؛" such as death of a spouse, divorce"؛" medical and midwifery problems during the study "؛" detection of abnormalities or fetal death during the study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O94-O99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other obstetric conditions, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The classes will be held every two weeks for an hour and a half, for 8 times, with a maximum of 10 pregnant women, and includes 5 minutes of greetings, 30 minutes of training, 10 minutes for questions and answers, 30 minutes of physical exercise, and 10-15 minutes of relaxation, and the last 10-15 minutes is dedicated to video playback and questions and answers. Mothers wear comfortable clothes at the time of exercises and do their workouts with the trainer for 30 minutes at a suitable place. Mothers are recommended to do exercises and relaxation at home every day, and every two days, mother will receive a phone call, and they will be encouraged to exercise at home. After 36 weeks of the end of the classes, the questionnaires will be completed again by test group. Then the data analysis will be conducted and the results of the impacts of training and exercise classes on positive affection and vitality before and after the intervention</i_keyword>
      <i_keyword>The control group: receives the routine cares of prenatal clinic. and In order to regard the ethical principles in the control group, after the completion of training, they will be given educational pamphlet After 36 weeks of the end of the classes, the questionnaires will be completed again by control group. Then the data analysis will be conducted and the results of the impacts of training and exercise classes on positive affection and vitality before and after the intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Positive emotion. Timepoint: 4 month. Method of measurement: Positive and Negative Affect Scale Panas.</prim_outcome>
      <prim_outcome>Vitality. Timepoint: 4month. Method of measurement: Deci and Ryan vitality 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>Vice Chancellor of Research Technolog, Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-15</approval_date>
        <contact_name>Ethics Committee of the University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor of Research and Technology,Hamadan Univercity of Medical Siences,Shahid Fahmideh Avenue,Hamadan hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
