<?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>IRCT2014071216937N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-21</date_registration>
      <primary_sponsor>Vice Chancellor for research of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of premature  infant massage on mother attachment</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial the study of premature infant massage by mothers on maternal attachment behavior among infants hospitalized in neonatal intensive care  unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15711</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Statistics were performed using a table of random numbers reference book. Less than 81 were selected and participated in the study.&#13;
80 samples were divided in two qroups number 1 to 40 represents the experimental group and the numbers 41 to 80, representing the control group were classified.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of premature infant massage by mother on attachment behavior.</hc_freetext>
      <i_freetext>Intervention 1: After selecting the samples for starting the research and having enough and clear explanations for mothers about the goals and the type of the research by researcher, and also to clarify the attachment evaluation procedure and to express their attachment behavior to their infants is measured by the researcher before starting massage and the days 5 after massage. Acquiring written satisfaction, and are attendant in this project. In the experimental group a book with a training CD that is prepared by infants health office about massage training will be given to mothers. The massage is done from the tip of the infants toes in the way that the infant is without coverage or is just diapered. The massage training movie is played by the researcher for mothers. Massage training classes is hold in the two hospitals of conference saloon of hospitals.These saloons are equipped with the perfect audio visual system and the manipulation is done with the related authorities in the two hospitals to allow using this equipments. Training classes will be performed during 1 hour in 2 sessions, mothers will learn the massage practically and by face to face training, by the researche. They will practice on the maquette with attendance of the researcher. (The researcher will apply personally for massage training and also evaluation of attachment samples and she will not use the colleague). In the case that mother needs sessions and more hours for training,these training will be continued till the correct massage learning. The researcher control the research by observation of the massage by mothers on the maquette have a correct insight from the massage training. The exact performance of massage and having a correct insight of the massage training by mothers is controlled by the researcher by mothers observation of the maquette.in all stages of the massage training film, and in practical exercise of the massage, the researcher will be present beside mothers for fixing their problems and answering to their questions. (The researcher has received the massage certificate formerly). (Also the researcher telephon number is accessible to them all the time). First massage of the infant by the mother is done by researcher attendance. Every mother massage her infant by odorless olive oil once in 24 hours. For 15 minutes. (used olive oil is of the same trade mark for all samples). Massage is done for 5 days on the infants by their mothers. Evaluation of attachment of mothers in experimental group is done before the massage and the days 5 after massage. The evaluation is done by the researcher regarding spatial time allocation of 1 hour after massage. Attachment evaluation is started by the time the mother is on the infant’s bed and is ready to feed her infant and the evaluation would continue during this feeding, that is if the mother feed or contact her infant less than 15 minutes, the evaluation wouldn’t be accepted and will postpone to other time. (This point of evaluation will be concerned in both the control and experimental group). In order to measure mothers attachment by attachment evaluation scale, 15 minutes interaction between mother and the infant constantly evaluate; in every minute in the first 30 second the mother behavior to the infant evaluated and in 2nd 30 second the behavior is recorded. Counting of seconds is done by counting watch. Before doing massage of the infant, the evaluation then is done in 5th days after starting the massage. Intervention 2: In control group mothers and infants will receive only routine care; (this caring contains doctor visit, daily weighting newborns, serum therapy, training of correct breast feeding to infant, intake and output control, needed training for discharge of the infant, their attachment assess after confirming the needed situations for entering the research, and getting the one turn written satisfactory and then it will be assess in 5th days after massage.</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>Soroor Sohrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7742 8716</telephone>
        <email>soroor.soh@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soroor Sohrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7742 8716</telephone>
        <email>soroor.soh@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Iranian mother; the baby is the result of a single pregnancy; infants 2500 gm birth weight or less and gestational age of 37 weeks or less; infants are clinically stable condition. Exclusion criteria: infants discharged before end of intervention; collide stability and general condition of the baby and mother</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>28 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>-----</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>-----</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After selecting the samples for starting the research and having enough and clear explanations for mothers about the goals and the type of the research by researcher, and also to clarify the attachment evaluation procedure and to express their attachment behavior to their infants is measured by the researcher before starting massage and the days 5 after massage. Acquiring written satisfaction, and are attendant in this project. In the experimental group a book with a training CD that is prepared by infants health office about massage training will be given to mothers. The massage is done from the tip of the infants toes in the way that the infant is without coverage or is just diapered. The massage training movie is played by the researcher for mothers. Massage training classes is hold in the two hospitals of conference saloon of hospitals.These saloons are equipped with the perfect audio visual system and the manipulation is done with the related authorities in the two hospitals to allow using this equipments. Training classes will be performed during 1 hour in 2 sessions, mothers will learn the massage practically and by face to face training, by the researche. They will practice on the maquette with attendance of the researcher. (The researcher will apply personally for massage training and also evaluation of attachment samples and she will not use the colleague). In the case that mother needs sessions and more hours for training,these training will be continued till the correct massage learning. The researcher control the research by observation of the massage by mothers on the maquette have a correct insight from the massage training. The exact performance of massage and having a correct insight of the massage training by mothers is controlled by the researcher by mothers observation of the maquette.in all stages of the massage training film, and in practical exercise of the massage, the researcher will be present beside mothers for fixing their problems and answering to their questions. (The researcher has received the massage certificate formerly). (Also the researcher telephon number is accessible to them all the time). First massage of the infant by the mother is done by researcher attendance. Every mother massage her infant by odorless olive oil once in 24 hours. For 15 minutes. (used olive oil is of the same trade mark for all samples). Massage is done for 5 days on the infants by their mothers. Evaluation of attachment of mothers in experimental group is done before the massage and the days 5 after massage. The evaluation is done by the researcher regarding spatial time allocation of 1 hour after massage. Attachment evaluation is started by the time the mother is on the infant’s bed and is ready to feed her infant and the evaluation would continue during this feeding, that is if the mother feed or contact her infant less than 15 minutes, the evaluation wouldn’t be accepted and will postpone to other time. (This point of evaluation will be concerned in both the control and experimental group). In order to measure mothers attachment by attachment evaluation scale, 15 minutes interaction between mother and the infant constantly evaluate; in every minute in the first 30 second the mother behavior to the infant evaluated and in 2nd 30 second the behavior is recorded. Counting of seconds is done by counting watch. Before doing massage of the infant, the evaluation then is done in 5th days after starting the massage.</i_keyword>
      <i_keyword>In control group mothers and infants will receive only routine care; (this caring contains doctor visit, daily weighting newborns, serum therapy, training of correct breast feeding to infant, intake and output control, needed training for discharge of the infant, their attachment assess after confirming the needed situations for entering the research, and getting the one turn written satisfactory and then it will be assess in 5th days after massage.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attachment. Timepoint: Before massageand and the day5 after massage. Method of measurement: Calculated by taking the average frequencyof attachment behavior By maternal attachment observation form.</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 of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Sixth Floor, Central University, Qods St, Keshavarz Blvd, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
