<?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>IRCT201102265912N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-01-08</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>massage with sunflower oil and sesame oil</public_title>
      <acronym></acronym>
      <scientific_title>the effect of massage with sunflower oil and sesame oil  on crying, sleeping and infant growth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6376</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>2-3</phase>
      <hc_freetext>crying ,sleep  and Growth infant.</hc_freetext>
      <i_freetext>Intervention 1: Massage with sunflower oil and sesame seeds in this study in order to massage with sunflower oil or sesame oil manufacturing company Baryj Essence Kashan was with 10 cc of oil twice a day every 15 minutes for 4 weeks  doing be by the mother on the infant. Intervention 2: Control: In order to study without the use of massage oils twice daily (morning and afternoon) every 15 minutes for 4 weeks will  perform by mothers on infant.</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>Mandana Mrmohammadali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrat ST,Tohid Sq, Faculty of Nursing and Midwifery  Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6690 4252</telephone>
        <email>mirmohammad@tums.ac.i</email>
        <affiliation>Tehran University of Medical Siences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mandana Mirmohammadali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrat ST,Tohid Sq, Faculty of Nursing and Midwifery  Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6690 4252</telephone>
        <email>mirmohammad@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Siences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1) term infants (42-37 ) 2) 3 birth weight 4000-2500 g) singleton 4) fed exclusively with breast milk 5) absence of obvious disease or birth abnormalities 6) the first child of 7 ) minimal maternal Education in secondary school 8) lack of maternal diseases such as hypertension, diabetes, pregnancy, postpartum depression or any psychiatric illness related to maternal 9) no history of hospitalization due to disease, infant 10) lack of separation of infant from mother benchmarks withdrawal from the study: 1) sensitivity to any of the oils used for massage 2) disease public or skin infant during the study, 3) no intervention in four sessions consecutive or intermittent (48 h) 4) failure to complete the application form parents crying baby for 24 hours at least 5) infant feeding with artificial milk, 6)  NO mother's illness</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>z76.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Health supervision and care of other healthy infant and child</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Massage with sunflower oil and sesame seeds in this study in order to massage with sunflower oil or sesame oil manufacturing company Baryj Essence Kashan was with 10 cc of oil twice a day every 15 minutes for 4 weeks  doing be by the mother on the infant</i_keyword>
      <i_keyword>Control: In order to study without the use of massage oils twice daily (morning and afternoon) every 15 minutes for 4 weeks will  perform by mothers on infant</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Crying. Timepoint: befor intervention-end the first week-end the the second week-End of the third week and  the fourth week. Method of measurement: Daily form of crying parents.</prim_outcome>
      <prim_outcome>Sleep. Timepoint: befor intervention-end the first week-end the the second week-End of the third week and  the fourth week. Method of measurement: Daily form of crying parents.</prim_outcome>
      <prim_outcome>Weight. Timepoint: befor intervention-end the first week-end the the second week-End of the third week and  the fourth week. Method of measurement: Standard Scales.</prim_outcome>
      <prim_outcome>Height. Timepoint: befor intervention-end the first week-end the the second week-End of the third week and  the fourth week. Method of measurement: Meter Standard.</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 for research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-12-21</approval_date>
        <contact_name>Ethical Review Commiitee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Ghods street, Keshavarz BLD,Central building of Tehran Un Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
