<?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>IRCT2014021516581N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-03-03</date_registration>
      <primary_sponsor>Isfahan University of Medical Science</primary_sponsor>
      <public_title>The effects of relaxation technique on infertility stress</public_title>
      <acronym></acronym>
      <scientific_title>The effects of relaxation technique on stress in infertile women who reffere to the Esfahan infertility clinic.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15491</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, in addition to IVF or ICSI treatments , relaxation techniques for 12 sessions ( 6 sessions before transferring the embryo into the uterus and 6 sessions later) was implemented. For the implementation of this technique, the participants lying down on side , legs slightly bent, the muscles contraction not entered into any combination. Jacobson and Benson technique was used for reduce stress physical and mental. Jacobson techniques or progressive muscle relaxation , as muscle contraction and release of muscles took it . In this way the muscles divided into eight parts and techniques during an active contraction of the muscle for 5 seconds and then release of muscle for 30 seconds stress. The contraction and release of muscles were as follows Right leg; left leg; Right Hand; Left Hand; Abdomen and Lumbar; chest and shoulder; Head and Scalp. Benson technique , concentration to the entry and exit of air to the lungs and the creation of mental imagery. On arrival at the center of the samples , a questionnaire based on stress evaluation , was completed under the supervision of a researcher . These women in seventh day of their menstrual cycle were referred for ultrasound, infertility clinic , the questionnaires were completed at the same time . Relaxation technique for intervention group as a day of eighth, tenth , twelfth , fourteenth , sixteenth and seventeenth cycle will be performed by the researcher .in similar circumstances the previous meetings technique by listening to a CD or tape do. All questionnaires were completed under supervision of the researcher after embryo transfer to the uterus (after 2 weeks) and before pregnancy test administering. Intervention 2: In the control group treated by IVF or ICSI treatment for patients who were supposed to be the case, the researcher is not doing any additional intervention for these patients.</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>Sara Abedian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Semnan,5kilometer Damghan,Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 1335 4040</telephone>
        <email>s.abedian@semnan.iau.ac.ir,abedian_sara@yahoo.com</email>
        <affiliation>Islamic Azad University of Semnan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Abedian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Semnan,5kilometer Damghan,Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 1335 4040</telephone>
        <email>s.abedian@semnan.iau.ac.irabedian_sara@yahoo.com</email>
        <affiliation>Islamic Azad University of Semnan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :women who have a diagnosis of firstly infertility;women who age in the realm of 18 to 35 years;women who according to case health care, using the ART(IVF OR ICSI) for them;women who due to illness like depression and psychological. . . Under medical treatment;women who were not called a child.&#13;
 Exclusion criteria : women who have a diagnosis of secondry infertility;women who age under18 and after 35 years;women who according to case health care not using the ART(IVF OR ICSI) for them;women who due to illness like depression and psychological. . . not Under medical treatment;women who were called a child.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female Infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, in addition to IVF or ICSI treatments , relaxation techniques for 12 sessions ( 6 sessions before transferring the embryo into the uterus and 6 sessions later) was implemented. For the implementation of this technique, the participants lying down on side , legs slightly bent, the muscles contraction not entered into any combination. Jacobson and Benson technique was used for reduce stress physical and mental. Jacobson techniques or progressive muscle relaxation , as muscle contraction and release of muscles took it . In this way the muscles divided into eight parts and techniques during an active contraction of the muscle for 5 seconds and then release of muscle for 30 seconds stress. The contraction and release of muscles were as follows Right leg; left leg; Right Hand; Left Hand; Abdomen and Lumbar; chest and shoulder; Head and Scalp. Benson technique , concentration to the entry and exit of air to the lungs and the creation of mental imagery. On arrival at the center of the samples , a questionnaire based on stress evaluation , was completed under the supervision of a researcher . These women in seventh day of their menstrual cycle were referred for ultrasound, infertility clinic , the questionnaires were completed at the same time . Relaxation technique for intervention group as a day of eighth, tenth , twelfth , fourteenth , sixteenth and seventeenth cycle will be performed by the researcher .in similar circumstances the previous meetings technique by listening to a CD or tape do. All questionnaires were completed under supervision of the researcher after embryo transfer to the uterus (after 2 weeks) and before pregnancy test administering.</i_keyword>
      <i_keyword>In the control group treated by IVF or ICSI treatment for patients who were supposed to be the case, the researcher is not doing any additional intervention for these patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress score. Timepoint: before and after study. Method of measurement: Newton infertility stress questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pregnancy outcome. Timepoint: after study. Method of measurement: pregnancy test.</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>Isfahan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-02-06</approval_date>
        <contact_name>Isfahan University of Medical Science</contact_name>
        <contact_address>Isfahan University of Medical Sciencest,St. Hezar Jerib,Isfahan Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
