<?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>IRCT201112108362N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-21</date_registration>
      <primary_sponsor>Vice Chancellor for research Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The  comparison of two methods of music listening, by mother and fetus on the non-stress test outcome.</public_title>
      <acronym></acronym>
      <scientific_title>The  comparison of two methods of music listening, by mother and fetus on the non-stress test outcome in pregnant women referring to Hafez and Zeinabie hospital of Medical Sciences University of Shiraz 2011.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>213</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8837</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonstress testing in pregnant women.</hc_freetext>
      <i_freetext>Intervention 1: Music intervention in group1 by the mother and music run during the  second 10 minutes of nonstress test .and during of test not eating juice by mother or working for reduce mother,s stress. Intervention 2: Group 2, intervention of music listening by fetus from mother.s abdominal wall since 15 second after lost of 10 minute of non-stress testing. and during of test not eating juice by mother or working for reduce mother,s stress. Intervention 3: Third group is control.</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>Roghayeh Khoshkholgh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Hospital, Zand Avenue</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1835 4334</telephone>
        <email>Roghayekhoshkholgh@gmail.com</email>
        <affiliation>Shiraz  University of  Medical  Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Keshvarz Tahereh.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sattar-Khan Street, 16th Avenue</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1647 0339</telephone>
        <email>Keshavarzyt@yahoo.com</email>
        <affiliation>Shiraz University of  Medical  Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age range 35-18 years; gestational age 37- 40 weeks of pregnancy; singleton pregnancy; Women with uncomplicated pregnancies include: hypertension disorders, diabetic women requiring insulin, women suspected fetal inter uterine growth restricted, Women after 41 gestational age determinate by last menstruation date or ultrasound 16 to 20 weeks, premature rupture of membranes, multiple pregnancies, intrauterine death fetus, the embryonic lethal anomalies, fetus by cardiovascular anomalies, amniotic fluid disorders, the fetus was diagnosed with anencephaly; baseline of  heart rate between 160-110; No pregnant women by loss- hearing; no anatomic or mental disorders in mother (psychosis, schizophrenia, and uterine abnormalities); no chronic disease in mother such as heart disease, lung, kidney, chronic hypertension and diabetes; Not smoking and tobacco; not strenuous physical activity until two hours before the test; no use of analgesics, narcotics, sedative and  effected drugs on uterine contractions; Before entering the study vibroacoustic  stimulation, glucose or fruit juice is not used; at least 1.5 is the last time the mere promise of a meal; no nonreactive non-stress test; no experience in music education; The written consent form. Exclusion criteria: any problem occurred during the study, including placenta abruption, and cord prolapsed; not wanting to continue more; more than three positive non-stress test (non-reactive); presence of uterine contractions.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>w43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>expesure to the vibration</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Music intervention in group1 by the mother and music run during the  second 10 minutes of nonstress test .and during of test not eating juice by mother or working for reduce mother,s stress.</i_keyword>
      <i_keyword>Group 2, intervention of music listening by fetus from mother.s abdominal wall since 15 second after lost of 10 minute of non-stress testing. and during of test not eating juice by mother or working for reduce mother,s stress.</i_keyword>
      <i_keyword>Third group is control.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of acceleration of fetal heart rate. Timepoint: Initial 10 minuts of test, second 10 minuts of test. Method of measurement: Toito Japanese model by fetal echocardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reduce of time of nonstress testing. Timepoint: Initial 10 minuts of test, second 10 minuts of test. Method of measurement: Toito Japanese model by fetal echocardiography.</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 for research Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-11-11</approval_date>
        <contact_name>Shiraz University of  Medical  Sciences</contact_name>
        <contact_address>below Namazi Hospital, Zand Avenue Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
