<?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>IRCT2013061713691N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-05</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Newborn massage on paternal-Newborn attachment – Randomized control Trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Newborn massage on paternal-Newborn attachment – Randomized control Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13477</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>paternal-Newborn attachment.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group fathers during  3-day study massage their infant once daily.The father warm his hand and place infant on desk and applying oliv oil and start massage infant from leg and continue to arm, chest, head and back durind 8 phase that length aproximate 12 minute. 1) Begin with baby's feet. Using your thumb and index finger, stroke from toe to heel along the sole of the foot and toe to ankle on the top of the foot. &#13;
&#13;
2) Now, hold baby's leg gently at the ankle with one hand and using a slow, gentle circular motion, stroke from baby's ankle to hip with alternating hands. &#13;
&#13;
3) Move to baby's hands. Open baby's hand with your thumb and gently stroke the palm and top of the hand. Gently roll each of baby's fingers between your index finger and thumb. &#13;
&#13;
4) Hold baby's wrist with one hand and stroke from the wrist to the shoulder. Then, massage around each shoulder with gentle, small, circular motions. &#13;
&#13;
5) Using a circular motion and light touch, stroke baby's tummy in a clockwise direction below the rib cage. Avoid baby's naval if the cord is still attached. &#13;
&#13;
6) Then, place both hands on the center of baby's chest. Gently stroke out to the sides, bring your hands down and then back up to the center of the baby's chest. &#13;
&#13;
7) Cradle baby's head with you hands. Using both thumbs, gently stroke baby's head in a circular motion, moving around crown and ears. Avoid baby's soft spots. &#13;
&#13;
8) Place baby on tummy. Start with both hands together on baby's back. Slowly stroke baby from the shoulders to the buttocks and back to the shoulders. Intervention 2: In the Control group, Fathers visit  their infants as ward routine and have no accessibility to rsearch team during hospitalization.</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>Arshadi Bostanabad Mohammad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Sharyati Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 1479 6770</telephone>
        <email>arshadi@tbzmed.ac.irarshadi_m@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iinclution criteria: birth age above 37 week; birth weight above2500gr;Apgar scor of 1 and5 minute after birth was8-10;clinical stability; &#13;
Exclution criteria: serious illness of newborn</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>1 year</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z00.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Examination for normal comparison and control in clinical research programme</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group fathers during  3-day study massage their infant once daily.The father warm his hand and place infant on desk and applying oliv oil and start massage infant from leg and continue to arm, chest, head and back durind 8 phase that length aproximate 12 minute. 1) Begin with baby's feet. Using your thumb and index finger, stroke from toe to heel along the sole of the foot and toe to ankle on the top of the foot. &#13;
&#13;
2) Now, hold baby's leg gently at the ankle with one hand and using a slow, gentle circular motion, stroke from baby's ankle to hip with alternating hands. &#13;
&#13;
3) Move to baby's hands. Open baby's hand with your thumb and gently stroke the palm and top of the hand. Gently roll each of baby's fingers between your index finger and thumb. &#13;
&#13;
4) Hold baby's wrist with one hand and stroke from the wrist to the shoulder. Then, massage around each shoulder with gentle, small, circular motions. &#13;
&#13;
5) Using a circular motion and light touch, stroke baby's tummy in a clockwise direction below the rib cage. Avoid baby's naval if the cord is still attached. &#13;
&#13;
6) Then, place both hands on the center of baby's chest. Gently stroke out to the sides, bring your hands down and then back up to the center of the baby's chest. &#13;
&#13;
7) Cradle baby's head with you hands. Using both thumbs, gently stroke baby's head in a circular motion, moving around crown and ears. Avoid baby's soft spots. &#13;
&#13;
8) Place baby on tummy. Start with both hands together on baby's back. Slowly stroke baby from the shoulders to the buttocks and back to the shoulders.</i_keyword>
      <i_keyword>In the Control group, Fathers visit  their infants as ward routine and have no accessibility to rsearch team during hospitalization.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attachment. Timepoint: before Intervention- 3 days post Intervention. Method of measurement: Paternal- infant attachment Questionnaire John Condon2008.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-06-03</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>South Sharyati Ave.- Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
