<?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>IRCT201407275168N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-19</date_registration>
      <primary_sponsor>Tabriz University of Medical Science</primary_sponsor>
      <public_title>Effect of Touch and Massage on urine cortisol hormon in preterm infants</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Gentle Human Touch and Massage Techniques, Field, on urine cortisol hormon in preterm infants: Randomized  Control Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5518</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stress in premature infants.</hc_freetext>
      <i_freetext>Intervention 1: The newborns in control group will receive routine massage and no intervention will be performed on them. Intervention 2: Gentle Touch group: For 15 min, the mother placed the ﬁngertips of one hand above the eyebrow line with the palm touching the preterm infant’s crown while the other hand was rested on the lower abdomen of the infant encompassing the&#13;
waist and the hip. Intervention 3: Massage Techniques, Field group: tactile and kinesthetic stimulation will carry out in 15-minute sessions.Each session consisted of 3 standardized phases of 5 minutes each, in which the infants were keep in a prone position in the 1st and 3rd phase. The neonates will gently stroke with the soft, smooth surfaces of all the fingers of both hands. The tactile stimulation procedure included 12 strokes at a rate of approximately 5 seconds per stroking motion over each region of the neonate in the following sequence: From the top of the head down the sides of the face to the neck, and vice versa; From the back of the neck to both ends of the shoulders, and vice versa; From the thighs down to the ankles, and vice versa; From the shoulders down the arms to the wrist, and vice versa In the middle phase, the neonate will make to lie in a supine position for kinesthetic stimulation that included 5 segments of 1 minute each which consist of 6 passive flexion/extension movements, each lasting 10sec. The stimulation will do on each arm, then each leg and lastly both legs together.</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>Malihe Assadollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Pediatrics, School of nursing and Midwifery, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1479 9713</telephone>
        <email>assadollahim@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malihe Assadollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Shariety St. Faculty of Nursing &amp; Midwifery,Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1477 0648</telephone>
        <email>assadollahim@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:30-36 gestational ages, 7-10 day passed from Date of Birth,Infants cared in cut or incubator that under any means for respiratory ventilation such as nasal cannula, positive pressure applied through the nose, mask, and not ventilator.Infants cared in cut or incubator that not intravenous or intramuscular medication instructions or blood sampling, and only remained in word due to access weight.Exclusion criteria:If have symptoms like(fever, respiratory distress,muscle stiffness, vomiting) infant massage will stop.If infant was allergy to sunflower oil.If cases such as intraventricular hemorrhage ,necrotizing  enterocolitis  , patent ducts arteriosus ,sepsis,acute lung disease or anemia (Hb&lt;10gm/dl) found during the study.Infants that their mothers not regular perform massage or therapeutic touch program on schedule(at least once a day for 5 day),be excluded of study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Reaction to severe stress, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The newborns in control group will receive routine massage and no intervention will be performed on them.</i_keyword>
      <i_keyword>Gentle Touch group: For 15 min, the mother placed the ﬁngertips of one hand above the eyebrow line with the palm touching the preterm infant’s crown while the other hand was rested on the lower abdomen of the infant encompassing the&#13;
waist and the hip.</i_keyword>
      <i_keyword>Massage Techniques, Field group: tactile and kinesthetic stimulation will carry out in 15-minute sessions.Each session consisted of 3 standardized phases of 5 minutes each, in which the infants were keep in a prone position in the 1st and 3rd phase. The neonates will gently stroke with the soft, smooth surfaces of all the fingers of both hands. The tactile stimulation procedure included 12 strokes at a rate of approximately 5 seconds per stroking motion over each region of the neonate in the following sequence: From the top of the head down the sides of the face to the neck, and vice versa; From the back of the neck to both ends of the shoulders, and vice versa; From the thighs down to the ankles, and vice versa; From the shoulders down the arms to the wrist, and vice versa In the middle phase, the neonate will make to lie in a supine position for kinesthetic stimulation that included 5 segments of 1 minute each which consist of 6 passive flexion/extension movements, each lasting 10sec. The stimulation will do on each arm, then each leg and lastly both legs together.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decrease cortisol in Massage by Techniques, Field. Timepoint: before and after the5-day intervention period. Method of measurement: The concentration of cortisol was measured by Radio Immuno Assay (cemilominesanse) by liasow device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Decrease cortisol in gentle touch. Timepoint: before and after the 5-day intervention period. Method of measurement: The concentration of cortisol was measured by Radio Immmuno Assay(CEMILOMINOSANS) by LIASOW device.</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>Tabriz University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-14</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central Building of Tabriz University of Medical Sciences,Golgasht Avenue, azadi street,Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
