<?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>IRCT201204116918N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-08-09</date_registration>
      <primary_sponsor>Deputy of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>massage effect and jaundice</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two Massage Techniques, Field and Vimala, on reduction  of  Physiological Jaundice in Term and Late Preterm Infants: A Single-blind Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7353</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>neonatal Physiological jaundice.</hc_freetext>
      <i_freetext>Intervention 1: The newborns in control group will receive routine care and no intervention will be performed on them. Intervention 2: In first 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. Intervention 3: In second  group;  massage will carry out in 15-minute sessions; Each session consisted of 2 standardized phases. First phase in supine position; Face: Gently massage upper lids with your thumbs outward, from the nose to the cheeks; slide your thumbs from the upper lip to the cheeks; then under the ears with index and middle finger from ears the chin; Arms and hands: Gently massage the armpit with circular movements; slide your hands from the shoulder to the wrists; use twisting movements in opposite direction; Chest: Slide both hands starting from the midline to the sides, from the sides to midline. Abdomen: Slide hand down the abdomen, alternating left and right; slide hands together from right to left over the abdomen. Slide your hands downward on the left side, upward on the right side of the abdomen, then over the belly and bottom and coming down on the left side (inverted U). Slide fingertips of both hands over the abdomen, from right to left. Legs and feet: Slide your hands from the thigh to the ankle, with twisting movements in opposite directions over thigh, leg, and foot; slide hands from ankle to thigh with ascending movements. Finally, turn the child facedown. Slide both hands from the back of the neck to the hips from top to bottom, alternating. Slide your hands from side to side in opposite directions; with the index and middle finger draw circles from top to bottom following the spine.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedrasooli Alehe</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Shariety St ; Faculty of Nursing &amp; Midwifery ; Tabriz ; Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1479 0365</telephone>
        <email>seyyedrasooly@tbzmed.ac.ir</email>
        <affiliation>Faculty of Nursing &amp; Midwifery of Tabriz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  over 35 weeks gestational age; weighing between 2000-4000g; apgar score between 8-10 for first minute and fifth minute; having no congenital disease and problems such as neonatal asphyxia, ecchymosis, birth trauma, congenital infection. exclusion criteria: starting phototherapy in result of elevated total billirubin level; recieving billirubin-lowering drugs.</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>4 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P59.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal jaundice, 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 care and no intervention will be performed on them.</i_keyword>
      <i_keyword>In first 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>
      <i_keyword>In second  group;  massage will carry out in 15-minute sessions; Each session consisted of 2 standardized phases. First phase in supine position; Face: Gently massage upper lids with your thumbs outward, from the nose to the cheeks; slide your thumbs from the upper lip to the cheeks; then under the ears with index and middle finger from ears the chin; Arms and hands: Gently massage the armpit with circular movements; slide your hands from the shoulder to the wrists; use twisting movements in opposite direction; Chest: Slide both hands starting from the midline to the sides, from the sides to midline. Abdomen: Slide hand down the abdomen, alternating left and right; slide hands together from right to left over the abdomen. Slide your hands downward on the left side, upward on the right side of the abdomen, then over the belly and bottom and coming down on the left side (inverted U). Slide fingertips of both hands over the abdomen, from right to left. Legs and feet: Slide your hands from the thigh to the ankle, with twisting movements in opposite directions over thigh, leg, and foot; slide hands from ankle to thigh with ascending movements. Finally, turn the child facedown. Slide both hands from the back of the neck to the hips from top to bottom, alternating. Slide your hands from side to side in opposite directions; with the index and middle finger draw circles from top to bottom following the spine</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduction of billirubin level. Timepoint: during study, daily. Method of measurement: in mg/dl with use of cutaneous and blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stool frequency. Timepoint: daily. Method of measurement: observation.</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>Deputy of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-04-20</approval_date>
        <contact_name>Tabriz University of Medical Science</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>
